BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UV-ABSORBING COLLAMER FOLDABLE INTRAOCULAR LENS

    MDR report key: 557828 · Received December 3, 2004

    Report

    Report Number
    2023826-2004-02063
    Event Type
    Injury
    Date Received
    December 3, 2004
    Date of Event
    November 3, 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

    Narratives

    Description of Event or Problem · 1

    THE SURGEON IMPLANTED A CC4204BF COLLAMER LENS BUT THE HAPTIC BROKE WHILE IT WAS BEING INSERTED. THE INCISION WAS ENLARGED TO REMOVE THE LENS BUT SUTURES WERE NOT REQUIRED. THE FACILITY STATED IT WAS UNKNOWN AS TO WHY THE HAPTIC BROKE. AN MSI-PF INJECTOR AND AN SFC-25 FP CARTRIDGE WERE USED BUT THE LOT NUMBERS WERE NOT PROVIDED BY THE FACILITY.

    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 66 YR Other| R