BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGILENS

    MDR report key: 33722 · Received June 25, 1996

    Report

    Report Number
    MW1009375
    Event Type
    Malfunction
    Date Received
    June 25, 1996
    Date of Event
    June 12, 1996
    Report Date
    June 13, 1996
    Manufacturer
    CHIRON CORP.
    Product Code
    MOE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY THE CIRCULATING NURSE WAS ASKED TO GIVE TOBRADEX ON THE CORNEAL SHIELD. AT THIS TIME THE SCRUB TECH NOTICED IRREGULAR EDGES ON THE SHIELD. AFTER A CLOSER LOOK RPTR NOTICED A LARGE PORTION MISSING FROM THE EDGE. THE SURGEON REJECTED THE LENS AND ANOTHER ONE WAS OPENED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGILENS CORNEAL SHIELD MOE CHIRON CORP. NA Q2Q796A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA