BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSAR IOL

    MDR report key: 21403331 · Received February 18, 2025

    Report

    Report Number
    3012236936-2025-000032
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    January 27, 2025
    Report Date
    February 24, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474502000
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3, 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 D6A: IF IMPLANTED, GIVE DATE: N/A, AS LENS WAS REMOVED DURING THE SAME PROCEDURE. SECTION D6B: IF EXPLANTED, GIVE DATE: N/A, AS LENS WAS REMOVED DURING THE SAME PROCEDURE. SECTION E1 - TELEPHONE NUMBER: (B)(6). SECTION H3: THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT 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 AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: THIS INCIDENT IS A DUPLICATION OF FILE NUMBER CP-0560952. THEREFORE, THE EVENT IS CONSIDERED NOT REPORTABLE. A THOROUGH REVIEW OF THE FILE INDICATES THAT THE CIRCUMSTANCES, DETAILS, AND OUTCOMES OF THIS INCIDENT ARE IDENTICAL TO THOSE ALREADY RECORDED UNDER REPORT 3012236936-2025-0000363 SUBMITTED ON FEBRUARY 20, 2025. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS IMPLANTED AND THEN EXTRACTED. ACCOUNT PROVIDED THAT THE HAPTIC WAS BENT. NO ADDITIONAL INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2571845 SENSAR IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. AR40E 05050474502000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown