BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRAOCULAR LENS

    MDR report key: 22151929 · Received June 5, 2025

    Report

    Report Number
    MW5171119
    Event Type
    Injury
    Date Received
    June 5, 2025
    Date of Event
    February 18, 2025
    Report Date
    May 29, 2025
    Manufacturer
    BAUSCH & LOMB INCORPORATED
    Product Code
    HQL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A BAUSCH + LOMB LENS IMPLANT WAS PUT INTO MY RIGHT EYE. IT WAS A 10 ENVSTA SERIAL NO. (B)(6) BAUSCH & LOMB INC BLMB DIOP (B)(4). BAUSCH & LOMB INC HAS VOLUNTARILY RECALLED THAT LENS. I WAS BLIND IN THAT EYE FOR SEVERAL DAYS UNTIL IT STARTED TO RECEDE. IT'S NOW BEEN 3 MONTHS AND MY EYE IS ALMOST TOTALLY HEALED, OTHER THAN MY VISON IS STILL BLURRY. I AM TOLD THAT IT CAN BE ZAPPED TO IMPROVE IT. NEEDLESS TO SAY I'M A LITTLE HESITANT. I SAW THE DOCTOR EVERY DAY AFTER THE SURGERY FOR APPROXIMATELY A WEEK - WHICH GRADUALLY LESSONED AFTER THAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602716 INTRAOCULAR LENS INTRAOCULAR LENS HQL BAUSCH & LOMB INCORPORATED S3Q32507039

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Other