BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1912268 · Received November 23, 2010

    Report

    Report Number
    2023826-2010-01191
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 27, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (LENS WOULD NOT UNFOLD) -UNLABELED. EVAL: METHOD: LENS WORK ORDER SEARCH. RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND A PIECE OF ONE HAPTIC 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, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON INSERTED A 12.6 MM MICL 12.6 IMPLANTABLE COLLAMER LENS BUT THE LENS WOULD NOT UNFOLD IN THE PT'S EYE. THE SURGEON EJECTED MORE VISCOELASTIC TO TRY AND OPEN THE LENS, THEN USED A SINSKY HOOK TO TRY AND BREAK THE LENS EDGE ADHERENCE, WITH NO SUCCESS. THE LENS WAS THEN PULLED OUT OF THE EYE WITH FORCEPS, AND IN DOING SO, A PIECE OF THE ICL WAS TORN. THE BACKUP ICL WAS IMPLANTED WITH NO PROBLEM. ADD'L INFO WAS REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADD'L INFO IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL CO. MICL 12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE: MODEL SFC-45 FP -LOT # UNK| FOAM TIP PLUNGER MODEL FOAM TIP PLUNGER -LOT # UNK| INJECTOR: MODEL MSI-PF -LOT # UNK