BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALLERGAN

    MDR report key: 16476 · Received January 25, 1994

    Report

    Report Number
    16476
    Event Type
    Other
    Date Received
    January 25, 1994
    Date of Event
    August 9, 1993
    Report Date
    August 26, 1993
    Manufacturer
    ALLERGAN MEDICAL OPTICS
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD THE WRONG INTRA-OCULAR LENS INPLANTED. THE PATIENT NEEDED DIOPTER 13, BUT RECEIVED SIZE 13. THE LABELING WAS CORRECT, BUT THE STAFF MISREAD IT. (USER ERROR). PHYSICIAN FELT THAT THE LABELING IS CONFUSING. DIDN'T FEEL SIZE NEEDS TO BE LISTED ON PACKAGE RETURNED TO OR FOR REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLERGAN Implant INTRA OCULAR LENS HQL ALLERGAN MEDICAL OPTICS AC21B

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other