BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 2192208 · Received August 4, 2011

    Report

    Report Number
    2023826-2011-00686
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION:RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS OPTIC TORN AND A PIECE OF ONE HAPTIC TORN OFF AND MISSING. THE LENS WAS RETURNED IN LIQUID. (B)(4)

    Additional Manufacturer Narrative · 1

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS. (B)(4) - NO CONSEQUENCES OR IMPACT TO PATIENT. (B)(4). LENS NOT RETURNED.

    Description of Event or Problem · 1

    THE REPORTER STATED THERE WAS A LOADING ERROR WITH A CC4204A COLLAMER ASPHERIC SINGLE PIECE LENS, THE LENS TOUCHED THE PATIENT'S EYE BUT THERE WAS NO INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR INJECTOR SYSTEM NANOPOINT: LOT NUMBER UNK