BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VU-ABSORBING COLLAMER FOLDABLE INTRAOCULAR LENS

    MDR report key: 558500 · Received December 8, 2004

    Report

    Report Number
    2023826-2004-02061
    Event Type
    Injury
    Date Received
    December 8, 2004
    Date of Event
    November 9, 2004
    Report Date
    November 9, 2004
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE SURGEON IMPLANTED A CC4204BF COLLAMER LENS AND THEN REMOVED IT DUE TO A CAPSULE TEAR. AN MSI-PF INJECTOR AND AN SFC-25 FP CARTRIDGE WERE USED BUT THE LOT NUMBERS WERE NOT PROVIDED BY THE FACILITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE FACILITY BUT HAS NOT BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VU-ABSORBING COLLAMER FOLDABLE INTRAOCULAR LENS INTRAOCULAR LENS HQL STAAR SURGICAL CO. CC4204BF NA

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other| R