BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 2120357 · Received June 10, 2011

    Report

    Report Number
    2023826-2011-00508
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 17, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS. (B)(4). METHOD: LENS WORK ORDER SEARCH. RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND ONE HAPTIC TORN. A PIECE OF THE LENS OPTIC AND THE OTHER HAPTIC WERE TORN OFF AND MISSING. THE LENS WAS RETURNED IN LIQUID AND THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. CONCLUSIONS: 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 STATED THE SURGEON INSERTED A (B)(4) COLLAMER ASPHERIC SINGLE PIECE LENS AND THE HAPTIC TORE. THE LENS WAS REMOVED WITH NO PATIENT INJURY, NO ENLARGED INCISION OR SUTURES. ANOTHER SAME MODEL LENS WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CC4204A

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR INJECTOR SYSTEM MODEL NANOPOINT - LOT NUMBER UNK