BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPHTHALAS 532 LASER

    MDR report key: 40721 · Received September 4, 1996

    Report

    Report Number
    2028159-1996-00163
    Event Type
    Malfunction
    Date Received
    September 4, 1996
    Date of Event
    August 6, 1996
    Report Date
    September 4, 1996
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A POWER SURGE DURING THE PROCEDURE RESULTED IN A STRONGER BURN TO THE RETINA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPHTHALAS 532 LASER LASER PHOTOCOAGULATOR HQB ALCON LABORATORIES, INC. 532 LASER UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN