BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES TWENTY THOUSAND LEGACY & ACCESSORIES

    MDR report key: 36602 · Received August 30, 1996

    Report

    Report Number
    2028159-1996-00158
    Event Type
    Injury
    Date Received
    August 30, 1996
    Date of Event
    August 1, 1996
    Report Date
    August 30, 1996
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H11: PARTIAL INFO IN SECTION F PROVIDED BY CUSTOMER'S INITIAL REPORT. NO ADDITIONAL INFO RECEIVED TO DATE. F-10: 1757 - LABELED; 1422 - NA. CODES PROVIDED BY MFR. B-4: 8/1/96.

    Description of Event or Problem · 1

    CORNEAL BURN OCCURRED DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES TWENTY THOUSAND LEGACY & ACCESSORIES OPHTHALMIC SURGERY SYSTEM-CASSETTE PAK HQE ALCON LABORATORIES, INC. STTL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other