SENSAR IOL

Additional Manufacturer Narrative

SECTION A2: THE MEAN AGE WAS 28.9 ± 16.1 YEARS. SECTION A3A: 82 PATIENTS IN TOTAL AND 50.1% OF THE PATIENTS WERE MALE. SECTIONS A3B, A4, A5: INFORMATION UNKNOWN/NOT PROVIDED SECTION B3 - DATE OF EVENT: EXACT DATE NOT PROVIDED. ARTICLE ACCEPTANCE DATE: NOVEMBER 11, 2025. SECTION D4 - MODEL AND CATALOG #: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D4 - SERIAL #: UNKNOWN/ NOT PROVIDED. SECTION D4 - EXPIRATION DATE: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D4 - UDI #: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A - IMPLANT DATE: UNKNOWN/ NOT PROVIDED. SECTION D6B - EXPLANT DATE: N/A - LENS REMAINS IMPLANTED. SECTION H3 - THE INTRAOCULAR LENS WAS NOT RETURNED FOR ANALYSIS (THE DEVICE REMAINS IMPLANTED). THE SERIAL NUMBER FOR THIS DEVICE IS NOT AVAILABLE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4 - DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. CITATION: HELAYEL, H., MAGLIYAH, M. S., ALNUTAIFI, R., & BADAWI, A. H. (2025). SURGICAL OUTCOMES OF LENS REMOVAL WITH OR WITHOUT INTRAOCULAR LENS IMPLANTATION IN MARFAN SYNDROME: A RETROSPECTIVE COHORT STUDY. CLINICAL OPHTHALMOLOGY, 19, 4245¿4255. HTTPS://DOI.ORG/10.2147/OPTH.S557116. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

Description of Event or Problem

THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: SURGICAL OUTCOMES OF LENS REMOVAL WITH OR WITHOUT INTRAOCULAR LENS IMPLANTATION IN MARFAN SYNDROME: A RETROSPECTIVE COHORT STUDY. "A RETROSPECTIVE OBSERVATIONAL COHORT STUDY WAS CONDUCTED TO EVALUATE THE SURGICAL OUTCOMES OF LENSECTOMY WITH OR WITHOUT INTRAOCULAR LENS (IOL) IMPLANTATION IN PATIENTS WITH MARFAN SYNDROME PRESENTING AND ECTOPIA LENTIS. THE STUDY INCLUDED 55 PATIENTS (85 EYES) WHO UNDERWENT LENS SURGERY. THE SURGICAL APPROACH (USE OF CAPSULAR SUPPORT OR USE OF SCLERAL-FIXATED IOL (SFIOL) TECHNIQUES) WAS INDIVIDUALIZED ACCORDING TO THE DEGREE OF ZONULAR WEAKNESS AND CAPSULAR STABILITY. IN EYES WITH MINIMAL-TO-MILD SUBLUXATION, PHACOEMULSIFICATION MACHINE WAS USED TO REMOVE THE LENS THROUGH A CLEARCORNEAL INCISION AND A FOLDABLEPOSTERIOR CHAMBER IOL, EITHER SINGLE PIECE IN THE PRESENCE OF CAPSULAR TENSION DEVICE (CTD) AS DESCRIBED EARLIER OR THREE-PIECE (SENSAR AR40E ORMA60AC) WAS IMPLANTED IN THE BAG OR SULCUS DEPENDING ON THE DEGREE OF ZONULAR SUPPORT. IN PATIENTS WHO UNDERWENT LENS SURGERY USING THE SCLERAL-FIXATED IOL (SFIOL) TECHNIQUES (FLAP-AND-GLUE SFIOL), A THREE-PIECE IOL (ALCON MA60A OR SENSAR AR40E) WAS INSERTED. THE USE OF SCLERAL-FIXATED IOL (SFIOL) TECHNIQUES ARE CONSIDERED OFF-LABEL. POSTOPERATIVE COMPLICATIONS REPORTED IN THE STUDY INCLUDED POSTOPERATIVE GLAUCOMA (N=11 EYES). IT WAS REPORTED THAT 4 EYES THAT HAD PREVIOUSLY UNDERGONE LENSECTOMY WITH IOL IMPLANTATION LATER REQUIRED IOL EXCHANGE WITH IMPLANTATION OF A NEW SFIOL, APPROXIMATELY 8.3 ± 2.9 YEARS AFTER THE INITIAL SURGERY. IN ADDITION, IOL-RELATED EVENTS REPORTED INCLUDE IOL SUBLUXATION/DECENTRATION (N=6), IOL REPOSITIONING (N=1), AND IOL EXPLANTATION (N=1). FURTHERMORE, IT WAS REPORTED THAT APHAKIC CORRECTION WAS ACHIEVED USING SPECTACLES IN 29 EYES AND CONTACT LENSES IN 6 EYES. IT IS UNCLEAR IF THE COMPLICATIONS OCCURRED IN THE EYES IMPLANTED WITH THE SENSAR AR40E, OR THE NON-JNJ DEVICE.