SENSAR IOL

Additional Manufacturer Narrative

SECTION A3B, A4, AND A5: PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION B3 - DATE OF EVENT: EXACT DATE NOT PROVIDED. ARTICLE ACCEPTANCE DATE IS JULY 1, 2024. 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: S. DOGANAY, D. ERDEM, INVERTED TUNNEL SCLERAL FIXATION TECHNIQUE FOR DROPPED INTRAOCULAR LENS COMPLEX: THE DOUBLE-FLANGED SUTURE METHOD. ARQUIVOS BRASILEIROS DE OFTALMOLOGIA, 2025;88(4):E2024-0190. HTTP://DX.DOI.ORG/10.5935/0004-2749.2024-0190. 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: INVERTED TUNNEL SCLERAL FIXATION TECHNIQUE FOR DROPPED INTRAOCULAR LENS COMPLEX: THE DOUBLE-FLANGED SUTURE METHOD. RAPID RESPONSE TEAM COMMENTS: A RETROSPECTIVE, SINGLE-CENTER, OBSERVATIONAL STUDY WAS DONE TO DESCRIBE A MINIMALLY INVASIVE AND ATRAUMATIC TECHNIQUE FOR MANAGING THE POLYPROPYLENE SUTURE-ASSISTED SCLERAL FIXATION OF INTRAOCULAR LENS¿CAPSULAR BAG COMPLEX OR ARTIFICIAL IRIS¿INTRAOCULAR LENS COMPLEX FOR REPOSITIONING LATE LUXATED OR SUBLUXATED INTRAOCULAR LENS¿CAPSULAR BAGS AND ARTIFICIAL IRIS¿INTRAOCULAR LENS COMPLEXES. THE INTRAOCULAR LENSES (IOLS) USED IN THE PROCEDURES INCLUDED THREE-PIECE HYDROPHOBIC ACRYLIC IOLS, VIZ., ACRYSOF MA60AC (ALCON, FORT WORTH, TEXAS, USA) AND SENSAR AR40 (JOHNSON & JOHNSON VISION, IRVINE, CALIFORNIA, USA), AND A SINGLE-PIECE HYDROPHOBIC ACRYLIC IOL, ACRYSOF SA60AT (ALCON, FORT WORTH, TEXAS, USA), WAS ALSO USED. THE ARTIFICIAL IRIS¿IOL COMPLEX USED WAS REPER® MODEL C (NIZHNY NOVGOROD, RUSSIA). CONJUNCTIVAL PERITOMY WAS PERFORMED IN 4 (36%) PATIENTS, WHEREAS NOT PERFORMED IN 7 (63%) PATIENTS. PREOPERATIVELY, 7 PATIENTS (63%) WERE DIAGNOSED WITH A DISLOCATED IOL CAPSULAR COMPLEX, AND 3 PATIENTS (27%) HAD A DROPPED IOL CAPSULAR COMPLEX. AMONG THESE CASES, THREE-PIECE AND SINGLE-PIECE LENSES WERE DETECTED IN 7 (63%) AND 3 (27%) PATIENTS, RESPECTIVELY. FURTHERMORE, 1 PATIENT (9%) HAD A DISLOCATED ARTIFICIAL IRIS¿IOL COMPLEX. CASE 3 PATIENT ON FOLLOW-UP MONTH 9 HAD PREOPERATIVE DIAGNOSIS OF DROPPED IOL-CAPSULE (THREE-PIECE J&J) WITH PRIOR PARS PLANA VITRECTOMY (PPV) AND NO CONJUNCTIVAL PERITOMY. CASE 7 ON FOLLOW-UP MONTH 15 HAD PREOPERATIVE DIAGNOSIS OF DROPPED IOL-CAPSULE (THREE-PIECE J&J) WITH PRIOR PARS PLANA VITRECTOMY (PPV) AND APPLIED CONJUNCTIVAL PERITOMY. CASE 10 ON FOLLOW-UP MONTH 8 HAD PREOPERATIVE DIAGNOSIS OF DISLOCATED IOL-CAPSULE (THREE-PIECE J&J) WITH NO PRIOR PARS PLANA VITRECTOMY (PPV) AND NO CONJUNCTIVAL PERITOMY. CASE 11 ON FOLLOW-UP MONTH 10 HAD PREOPERATIVE DIAGNOSIS OF DISLOCATED IOL-CAPSULE (THREE-PIECE J&J) WITH NO PRIOR PARS PLANA VITRECTOMY (PPV) AND NO CONJUNCTIVAL PERITOMY. TO TREAT THE COMPLICATIONS, THE SCLERAL LOOP FIXATION OR CLOSED-LOOP HAPTIC TECHNIQUE WAS MODIFIED USING A 6/0 POLYPROPYLENE SUTURE. THE TECHNIQUE INVOLVED ACCESSING THE SCLERA THROUGH THE SAME ENTRY POINT TO CREATE A LOOP, FOLLOWED BY USING THE INVERTED TUNNEL TECHNIQUE TO EMBED THE FLANGE WITHIN THE SCLERA. THERE WERE NO FURTHER INTERVENTIONS REPORTED. NOTE: THIS FILE COVERS CASE 3, FEMALE PATIENT (AGE 73). SEPARATE REPORTS WILL BE SUBMITTED FOR THE OTHER PATIENTS. A COPY OF THE ARTICLE HAS BEEN PROVIDED WITH THIS FILING.