BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UV-ABSORBING COLLAMER FOLDABLE INTRAOCULAR LENS

    MDR report key: 566931 · Received January 24, 2005

    Report

    Report Number
    2023826-2005-00125
    Event Type
    Injury
    Date Received
    January 24, 2005
    Date of Event
    December 28, 2004
    Report Date
    December 30, 2004
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE SURGEON IMPLANTED A CC4204BF COLLAMER PLATE LENS BUT IT BROKE EJECTING FROM THE CARTRIDGE. THE INCISION WAS ENLARGED TO REMOVE THE LENS BUT SUTURES WERE NOT REQUIRED. THE NURSE STATED IT WAS UNK AS TO WHY THE LENS 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 UNKNOWN Required Intervention