BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 176766 · Received July 9, 1998

    Report

    Report Number
    2028159-1998-00196
    Event Type
    Injury
    Date Received
    July 9, 1998
    Date of Event
    June 12, 1998
    Report Date
    June 12, 1998
    Manufacturer
    ALCON LABORATORIES, INC
    Product Code
    HQE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER NOTED HE WAS NOT ACCUSTOMED TO SIZE OF "I/A" TIP. POSTERIOR CAPSULE TEAR OCCURRED; ANTERIOR VITRECTOMY REQUIRED "PC" INTRA OCULAR LENS IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention