BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 111299 · Received August 5, 1997

    Report

    Report Number
    1119421-1997-00070
    Event Type
    Injury
    Date Received
    August 5, 1997
    Report Date
    July 7, 1997
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED LENS WAS FOUND TO BE WITHIN SPECIFICATIONS AND NO DEFECTS WERE NOTED. NO SIMILAR COMPLAINTS HAVE BEEN REPORTED TO THIS LOT. THE MFR'S INTERNAL REFERENCE NUMBER IS 97L4447. THIS REPORT WAS MAILED IN TO FDA ON: 9/26/97. DISCLAMIER: THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONDIDERED TO BE AN ADMISSION THAT AN ALCON LABORATORIES, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY. NUMBER OF PERSONS AFFECTED = 1.

    Description of Event or Problem · 1

    USER FACILITY REPORTS LENS WOULD NOT FOLD PROPERLY AND WOUND WAS WIDENED.

    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