BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF

    MDR report key: 51719 · Received September 25, 1996

    Report

    Report Number
    1119421-1996-00115
    Event Type
    Malfunction
    Date Received
    September 25, 1996
    Report Date
    August 29, 1996
    Manufacturer
    ALCON LABORATORIES
    Product Code
    HQL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IF DEFECTIVE LENS WERE TO RECUR, IT COULD RESULT IN PATIENT INJURY. TYPE OF DEFECT WAS NOT REPORTED. NO PATIENT INJURY WAS REPORTED WITH THIS EXPERIENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF Implant INTRAOCULAR LENS HQL ALCON LABORATORIES MA60BM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN