BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UV-ABSORBING COLLAMER FOLDABLE INTRAOCULAR LENS

    MDR report key: 604197 · Received May 20, 2005

    Report

    Report Number
    2023826-2005-00630
    Event Type
    Injury
    Date Received
    May 20, 2005
    Date of Event
    April 21, 2005
    Report Date
    April 22, 2005
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE SURGEON IMPLANTED LENS BUT IT TORE WHILE BEING INSERTED. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND SUTURES WERE REQUIRED. THE NURSE STATED IT WAS UNK AS TO WHY THE LENS TORE. AN MSI-PF INJECTOR AND AN SFC-25 FP CARTRIDGE WERE USED BUT THE NURSE 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 91 YR Required Intervention