BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 2110733 · Received June 1, 2011

    Report

    Report Number
    2023826-2011-00482
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    April 18, 2011
    Report Date
    May 9, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCULAR LENS. (B)(4). RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS OPTIC TORN. THE LENS WAS RETURNED IN LIQUID AND THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A (B)(4) COLLAMER ASPHERIC SINGLE PIECE LENS BUT THE LENS WAS REMOVED DUE TO THE SURGEON CHANGING HIS MIND. THE LENS WAS UNSTABLE IN THE CAPSULE BAG AND THE BAG WAS TOO SMALL FOR THE LENS. THE LENS WAS REMOVED WITH NO PATIENT INJURY AND AN (B)(4) LENS WAS IMPLANTED. THE REPORTER STATED THE EVENT WAS NOT LENS RELATED.

    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 36 YR CARTRIDGE MODEL AND LOT NUMBER UNK| INJECTOR MODEL AND LOT NUMBER UNK