BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSAR IOL

    MDR report key: 25339480 · Received May 29, 2026

    Report

    Report Number
    3012236936-2026-000136
    Event Type
    Injury
    Date Received
    May 29, 2026
    Report Date
    May 29, 2026
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 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. SECTION H6 - HEALTH EFFECT - CLINICAL CODE 4581: NO CODE AVAILABLE (DEVICE DISLOCATION) 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 · 0

    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. REVIEW COMPLETION DATE: 05/06/2026 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 (B)(6) (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 THE CASE 10, MALE PATIENT (AGE: 78). SEPARATE REPORTS WILL BE SUBMITTED FOR THE OTHER PATIENTS. A COPY OF THE ARTICLE HAS BEEN PROVIDED WITH THIS FILING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521174 SENSAR IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1