BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLERGAN MEDICAL OPTICS

    MDR report key: 61712 · Received December 11, 1996

    Report

    Report Number
    61712
    Event Type
    Injury
    Date Received
    December 11, 1996
    Date of Event
    October 22, 1996
    Report Date
    October 30, 1996
    Manufacturer
    ALLERGAN MEDICAL OPTICS
    Product Code
    HQL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AFTER PLACEMENT OF THE POSTERIOR CHAMBER LENS, IT WAS DETERMINED THAT THERE WAS A DEFECTIVE HAPTIC. THIS LENS WAS EXPLANTED AND AN IDENTICAL DIOPTER LENS WAS PLACED AND DIALED INTO POSITION. THERE WAS NO INJURY TO THE PT. PROBLEM WAS IDENTIFIED IMMEDIATELY AND REPLACEMENT LENS WAS IMPLANTED DURING THE SAME SURGERY. EXPIRATION DATE: 2/2001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLERGAN MEDICAL OPTICS Implant INTRAOCULAR LENS HQL ALLERGAN MEDICAL OPTICS 5140NB *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention