BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H-10

    MDR report key: 2012284 · Received March 9, 2011

    Report

    Report Number
    2023826-2011-00202
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    January 3, 2011
    Report Date
    February 10, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULAR LENS. (B)(4) - NO CONSEQUENCES OR IMPACT TO PATIENT, LENS FLIPPED EVALUATION METHOD: LENS WORK ORDER SEARCH. RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS OPTIC TORN INTO TWO PIECES AND BOTH HAPTICS 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. IT SHOULD BE NOTED THAT THE INJECTOR AND CARTRIDGE WERE NOT RETURNED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A CQ2015A COLLAMER ASPHERIC THREE PIECE LENS AND THE LENS FLIPPED IN THE EYE. THE DOCTOR COULDN'T GET THE LENS TO FLIP BACK SO THE LENS WAS REMOVED. THE LENS WAS CUT INTO PIECES TO REMOVE 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 CQ2015A

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR CARTRIDGE: MODEL CQ CARTRIDGE-FP, LOT NUMBER UNK| INJECTOR: MODEL MSI-PM, LOT NUMBER UNK