BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 20995846 · Received December 20, 2024

    Report

    Report Number
    3012236936-2024-000341
    Event Type
    Malfunction
    Date Received
    December 20, 2024
    Date of Event
    November 25, 2024
    Report Date
    January 14, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFO: ADDITIONAL RECEIVED, IT WAS REPORTED THERE WAS NO MORE DETAILS REGARDING THE DAMAGE/ISSUE. IT WAS NOTED THERE WAS PROBABLY ERROR IN LOADING LENS INTO CARTRIDGE. IT WAS CONFIRMED THERE WAS NO PATIENT INJURY, COMPLICATIONS, OR MEDICAL TREATMENT OUTSIDE OF STANDARD OF CARE. NO FURTHER INFORMATION WAS RECEIVED. THE FOLLOWING SECTIONS HAS BEEN UPDATED ACCORDINGLY: SECTION H6: DEVICE CODE: 2524 DEVICE ADVANCEMENT ISSUE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. SECTION E1: REPORTER TELEPHONE NUMBER: (B)(6). SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION; 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN PATIENT'S OPERATIVE EYE, BUT WAS REMOVED DUE TO A DAMAGED HAPTIC. PATIENT TOLERATED WELL. A BACK UP LENS WAS OPENED AND IMPLANTED. NO FURTHER INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2312692 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown