BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES TEN THOUSAND COMPACT

    MDR report key: 138054 · Received December 9, 1997

    Report

    Report Number
    2028159-1997-00214
    Event Type
    Injury
    Date Received
    December 9, 1997
    Date of Event
    November 7, 1997
    Report Date
    November 10, 1997
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RPTR NOTED SEVEN SURGERIES ON 11/06/1997. FOUND ENDOPHTHALMITIS IN THREE PTS FIRST DAY POST-OP. PTS STABILIZED AFTER VANCOMYCIN IV. ONE PT CULTURED STREP AND REQUIRED AN INTRAVITREAL INJECTION. FOLLOW-UP INDICATED THAT OTHER TWO PTS CULTURED STREP ALSO, AS WELL AS THE CASSETTE DRAINAGE FLUID FROM THE THREE PTS. PTS APPEAR TO BE RECOVERING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES TEN THOUSAND COMPACT Implant PHACOEMULSIFICATION-ASPIRATION SYSTEM HQE ALCON LABORATORIES, INC. STTC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention