BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2455430 · Received February 6, 2012

    Report

    Report Number
    2023826-2012-00096
    Event Type
    Malfunction
    Date Received
    February 6, 2012
    Report Date
    January 9, 2012
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    HQL
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): METHOD - LENS WORK ORDER SEARCH. RESULT - VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND A SMALL PIECE OF HAPTIC TORN OFF AND MISSING. LENS WAS RETURNED IN LIQUID. A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINS WERE FOUND WITHIN THE SAME WORK ORDER. CONCLUSION - NO CONCLUSION CAN BE DRAWN. 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.

    Description of Event or Problem · 1

    THE REPORTER STATED THEY RECEIVED A MICL 13.2 MM IMPLANTABLE COLLAMER LENS AND A PIECE OF THE HAPTIC WAS MISSING WHEN THE LENS WAS TAKEN OUT OF THE VIAL. THERE WAS NO PT CONTACT. THERE WAS NO ATTEMPT TO LOAD THE LENS. BACKUP LENS, SAME MODEL AND SIZE WAS IMPLANTED. REPORTER STATED LENS WAS RECEIVED DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS HQL STAAR SURGICAL CO. MICL13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1