BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 62970 · Received January 9, 1997

    Report

    Report Number
    1119421-1997-00002
    Event Type
    Injury
    Date Received
    January 9, 1997
    Report Date
    September 16, 1996
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVALUATION OF THE RETURNED JOL, THE OPTIC WAS NOT FOUND TO BE HAZY, AS FIRST REPORTED, NOR WAS A SCRATCHED OPTIC OBSERVED AS LATER REPORTED BY THE IMPLANTING SURGEON.

    Description of Event or Problem · 1

    SURGEON REPORTS LENS HAD A SCRATCH ON IT WHICH WAS NOTED AFTER INSERTION. THE WOUND WAS WIDENED IN ORDER TO REMOVE THE LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF Implant INTRAOCULAR LENS HQL ALCON LABORATORIES, INC. MA30BA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention