BEUDAMED
    FDA Adverse Event Other Summary report: N

    UV-ABSORBING COLLAMER FOLDABLE INTRAOCULAR LENS

    MDR report key: 616142 · Received June 22, 2005

    Report

    Report Number
    2023826-2005-00804
    Event Type
    Other
    Date Received
    June 22, 2005
    Report Date
    May 19, 2005
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE SUGEON IMPLANTED A CC4204BF COLLAMER PLATE LENS BUT IT WAS REMOVED IN PIECES DUE TO A PROBLEM WITH THE PT'S EYE. THE CONTACT STATED THE LENS AND DELIVERY SYSTEM DID NOT MALFUNCTION NOR CAUSE ANY INJURY TO THE PT. AN MSI-PF INJECTOR AND AN SFC-25 FP CARTRIDGE WERE USED BUT THE CONTACT WAS UNABLE TO RECALL THE LOT NUMBERS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other