BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UV-ABSORBING COLLAMER FOLDABLE INTRAOCULAR LENS

    MDR report key: 565132 · Received January 12, 2005

    Report

    Report Number
    2023826-2005-00053
    Event Type
    Injury
    Date Received
    January 12, 2005
    Date of Event
    December 6, 2004
    Report Date
    December 13, 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
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE SURGEON IMPLANTED A CC4204BF COLLAMER PLATE LENS BUT IT WAS REMOVED DUE TO A CAPSULE TEAR. THE SURGEON DID NOT PERFORM A VITRECTOMY. THE NURSE STATED THAT IT IS UNKNOWN WHAT CAUSED THE CAPSULE TEAR. 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 UNKNOWN Other| R