BEUDAMED
    FDA Adverse Event Summary report: N

    IOL

    MDR report key: 13202 · Received February 25, 1994

    Report

    Report Number
    13202
    Date Received
    February 25, 1994
    Date of Event
    February 2, 1994
    Report Date
    February 25, 1994
    Manufacturer
    ALLERGAN MEDICAL OPTICS
    Product Code
    HQL
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IOL WAS IMPLANTED ON 2/2/94, HAPTIC LOOKED STRANGE ACCORDING TO DR, BUT STILL USED BECAUSE HAPTICS ARE FOLDED FOR INSERTION. FIRST DAY POST-OP LENS WAS DISPLACED WITH HAPTIC FORCING LENS OUT OF POSITION. DR TRIED TO CORRECT WITH MEDICATIONS WITHOUT SUCCESS. ON 2/16/94, DR SURGICALLY REPLACED LENS WITH SAME STYLE IOL. ON 2/17/94, VISION IMPROVED, HAS SOME PAIN BEYOND NORMALLY EXPERIENCED, BUT OVERALL, SEEMS TO BE DOING WELL ACCORDING TO DR. DR SAID IOL IMPLANT WAS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IOL Implant IOL FOLDABLE HQL ALLERGAN MEDICAL OPTICS SI26NB

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR