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Suggestion of serious incidents in medical devices used in anterior segment surgery. Proposing ideas (II)
Propuesta de incidentes graves en productos sanitarios utilizados en la cirugía del segmento anterior. Proponiendo ideas (II)
R. Lorente-Moorea, J. Mendicute del Barriob, M.V. Rojas Silvac, A. Macarro-Merinod, E. Larra Mateose,f, J.C. Pastorf,g,
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a Clínica Oftalmología Dr. Lorente, Ourense, Spain
b Hospital Universitario Donostia, San Sebastián, Spain
c Complexo Hospitalario Universitario A Coruña, A Coruña, Spain
d Centro Internacional de Oftalmología Avanzada, Madrid, Spain
e AJL Ophthalmic, Miñano-Alava, Spain
f Clúster de Oftalmología y Ciencias de la Visión, Cluster4Eye, Valladolid, Spain
g IOBA, Universidad de Valladolid, Valladolid, Spain
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The choroidal thinning (white arrow) at nasal level could be physiological and attributable to the patient’s myopia. Subfoveal hyperreflectivity resolved at two weeks (B) leaving a minimal sequel of subfoveal RPE thickening at 1.5 months (C). The outer nasal layers progressively recovered (B and C). In A-OCT 8<span class="elsevierStyleHsp" style=""></span>×<span class="elsevierStyleHsp" style=""></span>8 <span class="elsevierStyleItalic">en-face,</span> at ellipsoid layer level, hyperreflective points were observed surrounding the papilla (green arrow) at debut (D). After two weeks (E), these peripapillary hyperreflective points decreased but hyporeflective spots were observed (white arrow), which correlate with the disruption of the outer retina in autofluorescence. After 1.5 months (F), hyporeflective spots decreased and white peripapillary spots disappeared. 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Proposing ideas (II)" "tieneTextoCompleto" => true "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "R. Lorente-Moore, J. Mendicute del Barrio, M.V. Rojas Silva, A. Macarro-Merino, E. Larra Mateos, J.C. Pastor" "autores" => array:6 [ 0 => array:3 [ "nombre" => "R." "apellidos" => "Lorente-Moore" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] 1 => array:3 [ "nombre" => "J." "apellidos" => "Mendicute del Barrio" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] ] ] 2 => array:3 [ "nombre" => "M.V." "apellidos" => "Rojas Silva" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "aff0015" ] ] ] 3 => array:3 [ "nombre" => "A." 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"apellidos" => "Pastor" "email" => array:1 [ 0 => "josecarlos.pastor@uva.es" ] "referencia" => array:3 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">f</span>" "identificador" => "aff0030" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">g</span>" "identificador" => "aff0035" ] 2 => array:2 [ "etiqueta" => "*" "identificador" => "cor0005" ] ] ] ] "afiliaciones" => array:7 [ 0 => array:3 [ "entidad" => "Clínica Oftalmología Dr. Lorente, Ourense, Spain" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Hospital Universitario Donostia, San Sebastián, Spain" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Complexo Hospitalario Universitario A Coruña, A Coruña, Spain" "etiqueta" => "c" "identificador" => "aff0015" ] 3 => array:3 [ "entidad" => "Centro Internacional de Oftalmología Avanzada, Madrid, Spain" "etiqueta" => "d" "identificador" => "aff0020" ] 4 => array:3 [ "entidad" => "AJL Ophthalmic, Miñano-Alava, Spain" "etiqueta" => "e" "identificador" => "aff0025" ] 5 => array:3 [ "entidad" => "Clúster de Oftalmología y Ciencias de la Visión, Cluster4Eye, Valladolid, Spain" "etiqueta" => "f" "identificador" => "aff0030" ] 6 => array:3 [ "entidad" => "IOBA, Universidad de Valladolid, Valladolid, Spain" "etiqueta" => "g" "identificador" => "aff0035" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "<span class="elsevierStyleItalic">Corresponding author</span>." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Propuesta de incidentes graves en productos sanitarios utilizados en la cirugía del segmento anterior. Proponiendo ideas (II)" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Introduction</span><p id="par0180" class="elsevierStylePara elsevierViewall">In 2017, the European Union (EU) established a new regulation known as 2017/745 Medical Device Regulation or MDR<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> on medical devices, which requires all manufacturers to comply with certain requirements emphasizing safety aspects. Additionally, in March 2023, Royal Decree 192/2023<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> was published, outlining obligations for clinical centers that affect all health care professionals.</p><p id="par0185" class="elsevierStylePara elsevierViewall">Article 35 of the above-mentioned decree states that professionals aware of a serious incident must report it to the Spanish Agency for Medicines and Health Products (AEMPS) through its official online platform.<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> Each health care center must designate a person responsible for monitoring procedures arising from the application of this article and maintain a record—preferably electronic—of implantable products (classes IIa, IIb, and III; i.e., virtually all used in intraocular surgery).</p><p id="par0190" class="elsevierStylePara elsevierViewall">The issue arises when interpreting what can be considered a serious incident. In response to these uncertainties, the Medical Device Coordination Group (MDCG-EU) issued a document attempting to resolve a few doubts and questions.<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> They first clarify the difference between an incident and a serious incident. An incident may simply be a malfunction of a medical device, which, although does not necessarily need to be reported, needs to be considered by the companies. The document provides clinical practice guidelines to determine when an incident is considered serious (Article 2, Section 65, of the MDR), defining it as one that could or has the potential to cause serious health problems and, of course, death.</p><p id="par0195" class="elsevierStylePara elsevierViewall">Furthermore, specific conditions must be met, such as causing an undesirable effect on the patient, and there must be a reasonable cause-and-effect relationship between the use of a particular medical device and the effect.</p><p id="par0200" class="elsevierStylePara elsevierViewall">By clarifying these concepts, the MDCG indicates that serious incidents may include cases in which the physician has to adopt unplanned medical or surgical treatment, those that unusually extend the duration of the intervention, or those that result in the onset of a previously unforeseen chronic problem.</p><p id="par0205" class="elsevierStylePara elsevierViewall">Evidently, with such non-specific concepts, interpreting what constitutes or could be a serious incident is problematic for most ophthalmologists.</p><p id="par0210" class="elsevierStylePara elsevierViewall">The aim of this work is to share information derived from a consensus document prepared by the Ophthalmology and Vision Sciences Cluster<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> and a series of experts selected by the Spanish Society of Implant-Refractive Ocular Surgery (SECOIR), who have provided their surgical experience in identifying situations related to the use of medical devices in anterior segment surgery that could be considered serious incidents and, therefore, must be reported.</p><p id="par0215" class="elsevierStylePara elsevierViewall">Although the list is merely indicative and there may be situations not covered, we hope this work serves as guidance to our colleagues regarding this new legislation, which happens to be mandatory.</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0030">Materials and methods</span><p id="par0220" class="elsevierStylePara elsevierViewall">The Delphi method, also known as expert panel consensus,<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> was used.</p><p id="par0225" class="elsevierStylePara elsevierViewall">A group of 4 experts proposed by SECOIR and a facilitator was created. Experts are SECOIR members with significant experience, publications, and a willingness to participate. After an initial presentation of objectives, they were provided with the appropriate references. Furthermore, 2 additional meetings were held where all possible serious incidents were discussed, reaching a consensus.</p><p id="par0230" class="elsevierStylePara elsevierViewall">In case of doubts, PubMed was consulted in English for publications from the last 10 years.</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Results</span><p id="par0235" class="elsevierStylePara elsevierViewall"><a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a> through 3 list the situations that all members of the working group considered possible serious incidents—i.e., where consensus was reached—and, therefore, should be reported.</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0240" class="elsevierStylePara elsevierViewall">Of note that these must be complications not attributable to poor technique used by the surgeon or the use of an inappropriate technique, and in each case, the total surgical time—including the resolution of the complication—should be established.</p><p id="par0245" class="elsevierStylePara elsevierViewall">The incidents have been categorized into: 1) <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>, those related to viscoelastics and anterior capsule dyes; 2) <a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>, those related to intraocular lenses; and 3) <a class="elsevierStyleCrossRef" href="#tbl0015">Table 3</a>, those related to the use of other surgical medical devices, such as capsular rings, artificial irises, and other implants, as well as cases in which the responsibility for the incident may be due to several products.</p><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><elsevierMultimedia ident="tbl0015"></elsevierMultimedia><p id="par0250" class="elsevierStylePara elsevierViewall">Two references on surgical time are also included, which is considered normal for cataract surgery with phacoemulsification and intraocular lens (IOL) implantation; according to the National Health System (UK), time should range between 30 and 45 minutes.<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a> Another recent article<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a> established that the mean intervention time in a teaching hospital is 31.7 ± 14.03 minutes.</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Discussion</span><p id="par0255" class="elsevierStylePara elsevierViewall">The MDR<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> and the Ministry of Health RD<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> set stricter and updated standards for the marketing and monitoring of medical devices in the EU. Both address the definition of “undesirable secondary incident”, which in the MDR must be understood as any unwanted effects or signs following the normal use of a medical device or health product.</p><p id="par0260" class="elsevierStylePara elsevierViewall">Unwanted incidents can result from malfunction, deterioration in characteristics or inadequate performance of a product, or insufficient information about the product and its use that must be provided by the manufacturer. A failed treatment or a problem attributable to the surgeon should not be considered unwanted effects.</p><p id="par0265" class="elsevierStylePara elsevierViewall">Of note that unwanted effects are not considered in the risk analysis that the manufacturer must perform and, in general, are not quantified in technical documentation or product information. If they occur, they must be managed like any other incident.</p><p id="par0270" class="elsevierStylePara elsevierViewall">Lens surgery requires the use of drugs—pre, intra, and postoperative—equipment—phacoemulsification devices—viscoelastics and intraocular irrigation solutions, dyes, instruments, intraocular lenses, and implantation devices and sutures. All of these have been categorized as Class II medical devices and can be sources of problems.<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a></p><p id="par0275" class="elsevierStylePara elsevierViewall">The use of perioperative drugs is a common thing and can be a potential source of serious incidents, and problems may arise from the use of phacoemulsification systems. These aspects fall outside the scope of this work.</p><p id="par0280" class="elsevierStylePara elsevierViewall">Viscoelastics can be categorized, in simplified terms, into cohesive, dispersive, and viscoadaptive.<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a> This work does not distinguish between them.</p><p id="par0285" class="elsevierStylePara elsevierViewall">Regarding dyes, incidents can arise from the product, the use of inappropriate concentrations, or improper application techniques. Only serious incidents resulting from the first 2 have been considered.</p><p id="par0290" class="elsevierStylePara elsevierViewall">Intraocular lenses (IOLs) are now essential for solving visual and refractive situations after lens extraction or correction of high ametropias. In general, IOLs are made of combinations of acrylic polymers that determine their biocompatibility, tolerance, and long-term behavior. IOLs are characterized by their structure (material and design), and their interaction with light (optical designs), and with the eye (positioning). Therefore, serious incidents may arise from their structure, material, and design (breakages, opacifications, etc.), their interaction with light (dysphotopsias and undesirable visual phenomena), or with the eye, in the form of mispositioning. All 3 characteristics have been considered in identifying serious incidents.</p><p id="par0295" class="elsevierStylePara elsevierViewall">Finally, a series of devices that have been gradually incorporated into the routine clinical practice and are sources of new complications with insufficient bibliography<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> are addressed.</p><p id="par0300" class="elsevierStylePara elsevierViewall">Our recommendation is to carefully evaluate any incident; keep traceability of all materials used in surgery, from acquisition by the clinical center to implantation; record all details on the surgical sheet, including times, and if there are any doubts, report to the AEMPS as a possible serious incident.</p><p id="par0305" class="elsevierStylePara elsevierViewall">It is proposed to generate specific documentation on specific products regarding serious incidents, as well as the circumstances surrounding them, such as exposure time, variations in technique, and significant incidents based on the surgeon’s judgment. Having this information in a standardized manner, in addition to meeting quality standards, would help identify and relate some serious incidents with the use of certain medical products. Such actions do not imply any value judgment about the products and allow for the accumulation of very valuable information.</p><p id="par0310" class="elsevierStylePara elsevierViewall">Some incidents are only recognized by their unusual frequency. Only the reporting of serious incidents from different centers to a common registry could alert to the presence of an unexpected complication.</p><p id="par0315" class="elsevierStylePara elsevierViewall">Of note that many incidents may be common to different medical products. For this reason, we believe that, in the case of a serious incident, it would be advisable to record all materials and medical devices used and report them to the AEMPS, with its responsibility being to identify the possible causative agent.</p><p id="par0320" class="elsevierStylePara elsevierViewall">In conclusion, we hope that this type of expert team work and with the appropriate methodology will help Spanish ophthalmologists become familiar with certain concepts and increase their awareness of the need to identify and report what they consider to be serious incidents related to lens surgery.</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Conflicts of interest</span><p id="par0325" class="elsevierStylePara elsevierViewall">None declared.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:10 [ 0 => array:3 [ "identificador" => "xres2271188" "titulo" => "Abstract" "secciones" => array:1 [ 0 => array:1 [ "identificador" => "abst0005" ] ] ] 1 => array:2 [ "identificador" => "xpalclavsec1893145" "titulo" => "Keywords" ] 2 => array:3 [ "identificador" => "xres2271187" "titulo" => "Resumen" "secciones" => array:1 [ 0 => array:1 [ "identificador" => "abst0010" ] ] ] 3 => array:2 [ "identificador" => "xpalclavsec1893146" "titulo" => "Palabras clave" ] 4 => array:2 [ "identificador" => "sec0005" "titulo" => "Introduction" ] 5 => array:2 [ "identificador" => "sec0010" "titulo" => "Materials and methods" ] 6 => array:2 [ "identificador" => "sec0015" "titulo" => "Results" ] 7 => array:2 [ "identificador" => "sec0020" "titulo" => "Discussion" ] 8 => array:2 [ "identificador" => "sec0025" "titulo" => "Conflicts of interest" ] 9 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2024-01-12" "fechaAceptado" => "2024-06-21" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec1893145" "palabras" => array:5 [ 0 => "Royal Decree 192/2023" 1 => "Medical devices" 2 => "Anterior segment surgery" 3 => "Serious incidents" 4 => "Medical Device Regulation" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec1893146" "palabras" => array:5 [ 0 => "Real Decreto 192/2023" 1 => "Productos sanitarios" 2 => "Cirugía del segmento anterior" 3 => "Incidentes serios" 4 => "Reglamento de Productos Sanitarios de la Comisión Europea" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:2 [ "titulo" => "Abstract" "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">The entry into force of the regulation on medical devices obliges ophthalmologists to identify and report possible serious incidents arising from their use. Faced with the doubts that may arise about what can or cannot be considered a serious incident, a working group of members of the Spanish Society of Refractive and Implant Eye Surgery (SECOIR) and the ophthalmology and vision sciences cluster (Cluster4Eye), have prepared a consensus document that aims to guide ophthalmologists on some of the incidents that, in the experience of the work team, are not common or can cause serious damage to the patient’s function in relation to the use of medical devices. Incidents related to the use of viscoelastics, anterior capsule dyes, intraocular lenses, and other items used in anterior segment surgery have been addressed.</p></span>" ] "es" => array:2 [ "titulo" => "Resumen" "resumen" => "<span id="abst0010" class="elsevierStyleSection elsevierViewall"><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">La entrada en vigor del reglamento sobre productos sanitarios obliga a los oftalmólogos a identificar y reportar los posibles incidentes graves derivados de su utilización. Ante las dudas que pueden suscitarse sobre qué puede o no considerarse incidente grave, un grupo de trabajo, de miembros de la Sociedad Española de Cirugía Ocular Implanto Refractiva (SECOIR) y el clúster de oftalmología y ciencias de la visión (Cluster4Eye), han elaborado un documento que pretende orientar a los oftalmólogos sobre algunos de los incidentes que, en la experiencia del equipo de trabajo, no son habituales o pueden causar un serio daño a la función del paciente en relación con el uso de productos sanitarios. Se han abordado incidentes relacionados con el uso de viscoelásticos, colorantes de capsula anterior, lentes intraoculares y otros elementos utilizados en la cirugía del segmento anterior.</p></span>" ] ] "multimedia" => array:3 [ 0 => array:8 [ "identificador" => "tbl0005" "etiqueta" => "Table 1" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0005" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:1 [ "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">•</span><p id="par0005" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Permanent ocular hypertension:</span> Defined as a pressure > 21 mmHg for more than 2 months after surgery, or an increase over the preoperative values by > 4 mmHg.</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><ul class="elsevierStyleList" id="lis0010"><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">•</span><p id="par0010" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Permanent secondary hypertension with increased angular pigment after sulcus lens implantation:</span> The mean time to sustained hypertension is 21.9 ± 17.0 months, with a range from 0.5 to 48 months.</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><ul class="elsevierStyleList" id="lis0015"><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">•</span><p id="par0015" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Malignant glaucoma or misdirection syndrome</span>.</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><ul class="elsevierStyleList" id="lis0020"><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">•</span><p id="par0020" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Toxic anterior segment syndrome (TASS):</span> Acute inflammatory reaction, typically with membranes and fibrin in the anterior chamber. It has been associated with methylcellulose-based viscoelastics and the concomitant use of vancomycin and ceftazidime (if reporting TASS, include if any intracameral antibiotics were used).</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Serious incidents related to the use of anterior capsule dyes \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><ul class="elsevierStyleList" id="lis0025"><li class="elsevierStyleListItem" id="lsti0025"><span class="elsevierStyleLabel">•</span><p id="par0025" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Prolonged staining of the corneal endothelium:</span> Particularly if it doesn’t disappear within 24–48 hours.</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><ul class="elsevierStyleList" id="lis0030"><li class="elsevierStyleListItem" id="lsti0030"><span class="elsevierStyleLabel">•</span><p id="par0030" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Staining of the anterior vitreous and persistence of dye:</span> If it requires modification of the procedure or persists for more than 24–48 hours.</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><ul class="elsevierStyleList" id="lis0035"><li class="elsevierStyleListItem" id="lsti0035"><span class="elsevierStyleLabel">•</span><p id="par0035" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Staining of the intraocular lens (IOL):</span> Always report, specifying the brand and type of material of the IOL.</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><ul class="elsevierStyleList" id="lis0040"><li class="elsevierStyleListItem" id="lsti0040"><span class="elsevierStyleLabel">•</span><p id="par0040" class="elsevierStylePara elsevierViewall">Allergic reactions to the dye</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><ul class="elsevierStyleList" id="lis0045"><li class="elsevierStyleListItem" id="lsti0045"><span class="elsevierStyleLabel">•</span><p id="par0045" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Increased rigidity of the posterior capsule predisposing to rupture.</span> Described experimentally with indocyanine green (ICG) and trypan blue. Occurs between 1 and 3 minutes after continuous exposure to microscope light.</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab3688506.png" ] ] ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Serious incidents related to viscoelastic agents and anterior capsule dyes.</p>" ] ] 1 => array:8 [ "identificador" => "tbl0010" "etiqueta" => "Table 2" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0010" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:2 [ "leyenda" => "<p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Anterior chamber lenses with angular support, anterior chamber lenses fixed in the iris, posterior chamber lenses, phakic lenses, multifocal lenses, and accommodative lenses have been included.</p>" "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><ul class="elsevierStyleList" id="lis0050"><li class="elsevierStyleListItem" id="lsti0050"><span class="elsevierStyleLabel">•</span><p id="par0050" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Lens malposition, tilt or decentration with decreased visual acuity</span>: Due to design deficiencies of the IOL, not related to surgeries involving capsular instability (e.g., pseudoexfoliation) or insufficient capsular support (e.g., due to complications inherent to the surgical technique).</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><ul class="elsevierStyleList" id="lis0055"><li class="elsevierStyleListItem" id="lsti0055"><span class="elsevierStyleLabel">•</span><p id="par0055" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Glaucoma</span>: Provided it was not pre-existing before surgery, occurring in the context of an uncomplicated surgery, and if ocular hypertension persists > 1 month.</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><ul class="elsevierStyleList" id="lis0060"><li class="elsevierStyleListItem" id="lsti0060"><span class="elsevierStyleLabel">•</span><p id="par0060" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Cystoid macular edema</span>: If no other potential risk factors (e.g., diabetes, prior retinopathy) or intraoperative complications (e.g., capsular rupture) exist, and if it persists or does not improve after 1 month of topical treatment. It has been reported that cystoid macular edema can occur the day after surgery due to intracameral cefuroxime toxicity. Therefore, an early cystoid macular edema occurring within the first 15 days after surgery, should be reported as a serious incident.</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><ul class="elsevierStyleList" id="lis0065"><li class="elsevierStyleListItem" id="lsti0065"><span class="elsevierStyleLabel">•</span><p id="par0065" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Intraocular lens opacification</span>: Any opacification, whether superficial, deep, localized, or total, primary or secondary, should be considered an adverse effect.</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><ul class="elsevierStyleList" id="lis0070"><li class="elsevierStyleListItem" id="lsti0070"><span class="elsevierStyleLabel">•</span><p id="par0070" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Calcifications</span>: If they require lens replacement or cause a clinically relevant decrease in visual acuity.</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><ul class="elsevierStyleList" id="lis0075"><li class="elsevierStyleListItem" id="lsti0075"><span class="elsevierStyleLabel">•</span><p id="par0075" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">SSNGs (lens subsurface nanoglistening)</span>: If it requires lens replacement or results in a clinically relevant decrease in visual acuity.</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><ul class="elsevierStyleList" id="lis0080"><li class="elsevierStyleListItem" id="lsti0080"><span class="elsevierStyleLabel">•</span><p id="par0080" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Material breakage or defects observed after implantation</span>: Not attributable to improper lens handling, either in the optical or haptic parts.</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><ul class="elsevierStyleList" id="lis0085"><li class="elsevierStyleListItem" id="lsti0085"><span class="elsevierStyleLabel">•</span><p id="par0085" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Haptic adhesion to the lens body (optic)</span>.</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><ul class="elsevierStyleList" id="lis0090"><li class="elsevierStyleListItem" id="lsti0090"><span class="elsevierStyleLabel">•</span><p id="par0090" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Discoloration of tinted lenses</span>: If lens replacement is required or it is clinically significant.</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><ul class="elsevierStyleList" id="lis0095"><li class="elsevierStyleListItem" id="lsti0095"><span class="elsevierStyleLabel">•</span><p id="par0095" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Lens dislocation, subluxation, or luxation</span>.</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><ul class="elsevierStyleList" id="lis0100"><li class="elsevierStyleListItem" id="lsti0100"><span class="elsevierStyleLabel">•</span><p id="par0100" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Rapid cataract formation (phakic lenses)</span>: It is accepted that in patients aged 40 years, cataract progression occurs throughout more than 10 years.</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><ul class="elsevierStyleList" id="lis0105"><li class="elsevierStyleListItem" id="lsti0105"><span class="elsevierStyleLabel">•</span><p id="par0105" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Pupillary block</span>.</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><ul class="elsevierStyleList" id="lis0110"><li class="elsevierStyleListItem" id="lsti0110"><span class="elsevierStyleLabel">•</span><p id="par0110" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Z Syndrome</span>: In certain accommodative lenses, sometimes related to capsular fibrosis. The lens configuration in the capsular bag resembles a “Z”, causing asymmetric tilting of the lens, leading to optical aberrations and astigmatism.</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><ul class="elsevierStyleList" id="lis0115"><li class="elsevierStyleListItem" id="lsti0115"><span class="elsevierStyleLabel">•</span><p id="par0115" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Reduction in contrast sensitivity requiring lens replacement</span>: In multifocal and accommodative lenses.</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab3688508.png" ] ] ] ] "descripcion" => array:1 [ "en" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Proposed serious incidents related to intraocular lenses.</p>" ] ] 2 => array:8 [ "identificador" => "tbl0015" "etiqueta" => "Table 3" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0015" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:2 [ "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><ul class="elsevierStyleList" id="lis0120"><li class="elsevierStyleListItem" id="lsti0120"><span class="elsevierStyleLabel">•</span><p id="par0120" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">UGH syndrome (uveitis-glaucoma-hyphema syndrome)</span>: Frequently reported with 1-piece acrylic lenses.</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><ul class="elsevierStyleList" id="lis0125"><li class="elsevierStyleListItem" id="lsti0125"><span class="elsevierStyleLabel">•</span><p id="par0125" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Glaucoma</span>.</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><ul class="elsevierStyleList" id="lis0130"><li class="elsevierStyleListItem" id="lsti0130"><span class="elsevierStyleLabel">•</span><p id="par0130" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Persistent uveitis</span>.</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><ul class="elsevierStyleList" id="lis0135"><li class="elsevierStyleListItem" id="lsti0135"><span class="elsevierStyleLabel">•</span><p id="par0135" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Prosthesis dislocation or luxation</span>.</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><ul class="elsevierStyleList" id="lis0140"><li class="elsevierStyleListItem" id="lsti0140"><span class="elsevierStyleLabel">•</span><p id="par0140" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Corneal decompensation</span>.</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><ul class="elsevierStyleList" id="lis0145"><li class="elsevierStyleListItem" id="lsti0145"><span class="elsevierStyleLabel">•</span><p id="par0145" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Implant breakage during routine handling</span>: Breakage due to prosthetic fragility has been reported in relation to PMMA (polymethyl methacrylate) irradiation treatment.</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><ul class="elsevierStyleList" id="lis0150"><li class="elsevierStyleListItem" id="lsti0150"><span class="elsevierStyleLabel">•</span><p id="par0150" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Need for further secondary surgeries</span>.</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t">Incidents where responsibility may be shared by multiple medical devices \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><ul class="elsevierStyleList" id="lis0155"><li class="elsevierStyleListItem" id="lsti0155"><span class="elsevierStyleLabel">•</span><p id="par0155" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Corneal edema persisting for 1 month after surgery</span>: Generally due to endothelial insufficiency. In the absence of surgical complications, endothelial cell loss should not exceed 6%–7% from phacoemulsification.</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><ul class="elsevierStyleList" id="lis0160"><li class="elsevierStyleListItem" id="lsti0160"><span class="elsevierStyleLabel">•</span><p id="par0160" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Chronic endothelial cell loss</span>: Especially in lenses located in the anterior chamber. Acceptable values are 6% after 1 year and 8.5% after 4 years. Greater losses recommend lens explantation. These have been associated with viscoelastic agents that should initially be stable over time and with intraocular lenses, where they may progress over time.</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><ul class="elsevierStyleList" id="lis0165"><li class="elsevierStyleListItem" id="lsti0165"><span class="elsevierStyleLabel">•</span><p id="par0165" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Infectious endophthalmitis in the absence of patient risk factors</span>: In such cases, include references to all products used during surgery.</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><ul class="elsevierStyleList" id="lis0170"><li class="elsevierStyleListItem" id="lsti0170"><span class="elsevierStyleLabel">•</span><p id="par0170" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">Non-infectious uveitis</span>: Tabulate the intensity of the inflammatory reaction. The SUN Working Group<a class="elsevierStyleCrossRef" href="#tblfn0005">*</a> classification can be used. A reaction of ≥ 1 in cells or “flare” 3 months after surgery should be considered a serious incident. Report all medical devices used during surgery.</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n \t\t\t\t\ttable-entry\n \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n \t\t\t\t\ttop\n \t\t\t\t"><ul class="elsevierStyleList" id="lis0175"><li class="elsevierStyleListItem" id="lsti0175"><span class="elsevierStyleLabel">•</span><p id="par0175" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleBold">TASS (Toxic anterior segment syndrome)</span>.</p></li></ul> \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab3688507.png" ] ] ] "notaPie" => array:1 [ 0 => array:3 [ "identificador" => "tblfn0005" "etiqueta" => "*" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Jabs et al.<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a></p>" ] ] ] "descripcion" => array:1 [ "en" => "<p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Serious incidents related to capsular rings and other implants.</p>" ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:10 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "Reglamento (UE) 2017/745 del Parlamento Europeo y del Consejo de 5 de abril de 2017 sobre los productos sanitarios, por el que se modifican la Directiva 2001/83/CE, el Reglamento (CE) n.◦ 178/2002 y el Reglamento (CE) n.◦ 1223/2009 y por el que se derogan las Directivas 90/385/CEE y 93/42/CEE del Consejo. 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