BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UV-ABSORBING COLLAMER FOLDABLE INTRAOCULAR LENS

    MDR report key: 582792 · Received March 17, 2005

    Report

    Report Number
    2023826-2005-00329
    Event Type
    Injury
    Date Received
    March 17, 2005
    Date of Event
    February 14, 2005
    Report Date
    February 18, 2005
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE FACILITY STATED THAT THE SURGEON IMPLANTED A CC4204BF PLATE COLLAMER LENS. THE LENS TORE UPON INSERTION INTO THE EYE. THE INCISION WAS ENLARGED TO REMOVE THE LENS. A SUTURE WAS REQUIRED TO CLOSE THE WOUND. THE FACILITY WAS UNABLE TO PROVIDE THE INJECTOR AND CARTRIDGE LOT NUMBERS. THE CARTRIDGE MODEL SFC-25 FP, INJECTOR MODEL WAS UNKNOWN.

    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