BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 2873133 · Received December 13, 2012

    Report

    Report Number
    2023826-2012-00984
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 16, 2012
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME: COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULAR LENS. (B)(4). EVALUATION: RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED THE LENS WAS RECEIVED IN LIQUID, THE OPTIC WAS TORN AND A HAPTIC WAS TORN OFF AND MISSING. CLAIM# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HAPTIC BROKE AS THE LENS WAS INSERTED AND THE LENS WAS REMOVED WITHOUT ANY PATIENT INJURY. THE CUSTOMER PREFERS TO USE A COMPETITORS CARTRIDGE WITH THE LENS AND IT AWARE THAT THIS IS CONSIDERED OFF LABEL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEE H-10 INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY CQ2015A NA

    Patients

    Seq Age Sex Outcome Treatment
    1