BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSAR IOL

    MDR report key: 21653352 · Received March 20, 2025

    Report

    Report Number
    3012236936-2025-000079
    Event Type
    Malfunction
    Date Received
    March 20, 2025
    Date of Event
    February 17, 2025
    Report Date
    March 20, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474502079
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A3B, A4, A5 AND A6: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D6B: IF EXPLANTED, GIVE DATE: UNKNOWN, INFORMATION NOT PROVIDED. SECTION E1: TITLE, EMAIL ADDRESS, CITY, STATE, POST OFFICE OR ZIP CODE: UNKNOWN/NOT PROVIDED SECTION E1: PHONE NUMBER: (B)(6). SECTION H3: THE DEVICE WAS NOT RETURNED FOR ANALYSIS AS THE LENS REMAIN IMPLANTED IN THE EYE. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. THE COMPLAINT ISSUE REPORTED COULD NOT BE CONFIRMED AND NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION COULD BE IDENTIFIED. JOHNSON & JOHNSON SURGICAL VISION WILL CONTINUE TO MONITOR THESE TYPES OF COMPLAINTS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING DAY 1 POST-OP, IT WAS NOTICED THAT 1 HAPTIC WAS MISSING. IOL REMAINS IN THE EYE AS IOL WAS IN POSITION AND DID NOT AFFECT THE PATIENT. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243176 SENSAR IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. AR40E 05050474502079

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male