BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1911742 · Received November 17, 2010

    Report

    Report Number
    2023826-2010-01085
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 25, 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
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS - VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS OPTIC TORN. ONE HAPTIC WAS TORN WITH A PIECE TORN OFF AND MISSING. THE LENS WAS RETURNED IN LIQUID. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSIONS - (NO CONCLUSION CAN BE DRAWN): BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE EVALUATION OF THE RETURNED PRODUCT, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON INSERTED A CC4204A COLLAMER ASPHERIC SINGLE PIECE LENS AND THE PLUNGER OVERRODE AND TORE THE BACK HAPTIC. THE LENS WAS INSERTED AND THE INCISION WAS ENLARGED SLIGHTLY TO REMOVE THE LENS. ANOTHER SAME MODEL LENS WAS IMPLANTED. SUTURES WERE NOT REQUIRED. THE PATIENT'S POST-OP BCVA WAS 20/25.

    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 84 YR Required Intervention FOAM TIP PLUNGER: MODEL FOAM TIP PLUNGER, LOT# UNK| CARTRIDGE: MODEL SFC-45 FP, LOT #UNK| INJECTOR: MODEL MSI-PF, LOT #UNK