BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENVISTA ENVY TORIC HYDROPHOBIC ACRYLIC INTRAOCULAR LENS

    MDR report key: 21859985 · Received April 17, 2025

    Report

    Report Number
    0001313525-2025-00056
    Event Type
    Injury
    Date Received
    April 17, 2025
    Date of Event
    January 14, 2025
    Report Date
    March 21, 2025
    Manufacturer
    BAUSCH + LOMB
    Product Code
    MFK
    UDI-DI
    10757770640338
    PMA / PMN Number
    P240005
    Removal / Correction Number
    RES96594
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REMAINS IMPLANTED. INVESTIGATION OF THIS EVENT IS IN PROGRESS. RECALL OF DEVICE IS UNDERWAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 DAY AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE LEFT EYE (OS), 1-2+ CENTRAL FOLDS, 3-4+ CELL, 3-4+ FIBRIN, THICK FIBRIN COVERING ANTERIOR CAPSULE, AND POOR VIEW OF IOL WAS OBSERVED. AN AC TAP WAS PERFORMED FOR CULTURE. THE RESULTS WERE INCONCLUSIVE, NO GROWTH. IN THE SURGEON'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS THE IOL; STATING IT WAS AN ISOLATED CASE, WITH NO INDICATION WHERE IT CAME FROM. PATIENT OUTCOME IS GOOD. MEDICATION ADMINISTERED DURING ORIGINAL SURGERY: INTRACAMERAL MOXIFLOXACIN. THE FOLLOWING MEDICATIONS WERE PRESCRIBED FOR USE AT HOME POST-OPERATIVELY: PRED/MOXI/BROM 1GTT OU QID UNTIL GONE. PREDNISOLONE ACETATE 1% OS Q 1 HOUR. MEDROL DOSE PACK-ORAL PREDNISONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1776861 ENVISTA ENVY TORIC HYDROPHOBIC ACRYLIC INTRAOCULAR LENS LENS, MULTIFOCAL INTRAOCULAR MFK BAUSCH + LOMB ETN 3Q26434 10757770640338

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention B+L INJECTOR SYSTEM, TOTALVISC, ALCON BSS