BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2180697 · Received May 5, 2011

    Report

    Report Number
    2023826-2011-00382
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Report Date
    April 8, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND PIECES OF BOTH PLATES HAPTICS ARE TORN OFF AND MISSING. LENS WAS RETURNED IN LIQUID. CONCLUSION: BASED ON THE COMPLAINT HISTORY 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 RPTR STATED THE SURGEON USED A MICL 12.6MM IMPLANTABLE COLLAMER LENS. THE LENS RIPPED, NO FURTHER INFO. FURTHER INFO WAS REQUESTED, BUT NONE HAS BEEN FORTHCOMING. IF ADD'L INFO BECOMES AVAILABLE, 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 COMPANY MICL12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 FORM TIP PLUNGER: MODEL AND LOT NUMBER UNK| INJECTOR: MODEL AND LOT NUMBER UNK| CARTRIDGE: MODEL AND LOT NUMBER UNK