BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    MDR report key: 1923775 · Received December 1, 2010

    Report

    Report Number
    2023826-2010-01212
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 3, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P990013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (NO LENS MALFUNCTION). EVAL, METHOD: LENS WORK ORDER SEARCH. RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS OPTIC AND ONE HAPTIC TORN INTO TWO PIECES. THE OTHER HAPTIC WAS 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: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND THE EVAL OF THE RETURNED PRODUCT, THE MOST LIKELY CAUSE OF THE EVENT WAS PT RELATED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON INSERTED A (B)(4) COLLAMER ASPHERIC SINGLE PIECE LENS BUT THE CAPSULE WOULD NOT SUPPORT THE LENS. THE LENS WAS CUT IN HALF TO REMOVE THE PT'S EYE, WITH NO PT INJURY, NO ENLARGED INCISION OR SUTURES. THE REPORTER INDICATED THAT THE CAUSE OF THE EVENT MAY POSSIBLY BE PT RELATED, NOT LENS RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL INTRAOCULAR LENS HQL STAAR SURGICAL CO. CC4204A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR INJECTOR: MODEL AND LOT NUMBER UNK| CARTRIDGE: MODEL AND LOT NUMBER UNK