BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPHTHALAS SP

    MDR report key: 291060 · Received August 18, 2000

    Report

    Report Number
    2028159-2000-00200
    Event Type
    Malfunction
    Date Received
    August 18, 2000
    Report Date
    July 20, 2000
    Manufacturer
    ALCON-IRVINE TECHNOLOGY CENTER
    Product Code
    HQB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOW-UP INDICATED PT WAS FOLLOWED ON A REGULAR BASIS AND THIS INCIDENT HAD NO CONSEQUENCE.

    Description of Event or Problem · 1

    REPORTER NOTED 1.7W POWER WAS SELECTED AND FIRED SEVERAL TIMES WITHOUT PROBLEM. SUDDENLY LASER DELIVERED A 2.25W SHOT, CAUSING A SMALL RETINAL BURN. NO INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPHTHALAS SP LASER PHOTOCOAGULATOR HQB ALCON-IRVINE TECHNOLOGY CENTER OPHTHALAS SP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO