BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 38868 · Received September 18, 1996

    Report

    Report Number
    2028159-1996-00166
    Event Type
    Injury
    Date Received
    September 18, 1996
    Date of Event
    August 19, 1996
    Report Date
    September 18, 1996
    Manufacturer
    ALCON LABORATORIES, INC
    Product Code
    HQE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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: 1388 - LABELED; 1422 -NA. CODES PROVIDED BY MFR. B-4: 8/1/96.

    Description of Event or Problem · 1

    DURING THE PROCEDURE POOR SUCTION CAUSED CAPSULE RUPTURE AND POSSIBLE CORNEAL BURN ON ONE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other