BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1911768 · Received November 24, 2010

    Report

    Report Number
    2023826-2010-01204
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    October 21, 2010
    Report Date
    November 1, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) EVAL RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND PIECES OF THE LENS OPTIC AND BOTH HAPTICS TORN OFF AND MISSING. THE LENS WAS RETURNED DRY AND THERE WAS EVIDENCE OF DARK RESIDUE. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON INSERTED A CC4204A COLLAMER ASPHERIC SINGLE PIECE LENS AND THE LENS TORE. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND ANOTHER LENS WAS IMPLANTED. THE REPORTER INDICATED THE CAUSE OF THE TORN LENS WAS DUE TO A LOADING ERROR. THIS IS ONE OF TWO LENSES USED FOR THIS PT - SEE MFR REPORT # 2023826-2010-01205.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL INTRAOCULAR LENS HQL STAAR SURGICAL CO. CC4204A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention CARTRIDGE: MODEL AND LOT NUMBER UNK| INJECTOR: MODEL AND LOT NUMBER UNK