BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV-ABSORBING COLLAMER FOLDABLE INTRAOCULAR LENS

    MDR report key: 832455 · Received November 4, 2004

    Report

    Report Number
    2023826-2004-01775
    Event Type
    Malfunction
    Date Received
    November 4, 2004
    Date of Event
    October 12, 2004
    Report Date
    October 13, 2004
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THAT THE LENS WAS STUCK IN THE CARTRIDGE. THE CARTRIDGE WAS RETURNED AND THE TIP OF THE BARRELL WAS SPLIT AND PART OF THE LENS WAS STUCK I N THE SPLIT. SURGICAL RESIDUE/DEBRIS ON PRODUCT. COMPLAINTS OF THIS NATURE ARE BEING INVESTIGATED.

    Description of Event or Problem · 1

    THE SURGEON ATTEMPTED TO IMPLANT A CC4204BF PLATE COLLAMER LENS. THE LEADING PORTION OF THE LENS HAD FOLDED BACK ON ITSELF PRIOR TO INSERTION INTO THE EYE. NO PT CONTACT. NO PT INJURY. THE IOL INJECTOR, MODEL AND LOT NUMBER UNK. THE IOL INJECTION CARTRIDGE, MODEL SFC-25FP, LOT NUMBER 1192435.

    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