BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF

    MDR report key: 180950 · Received August 4, 1998

    Report

    Report Number
    1119421-1998-00248
    Event Type
    Malfunction
    Date Received
    August 4, 1998
    Report Date
    July 1, 1998
    Manufacturer
    ALCON LABORATORIES,INC.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER FACILITY REPORTED THE LENS HAD A SCRATCH/MARK. THERE WAS NO PT IMPACT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN