BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2012512 · Received March 9, 2011

    Report

    Report Number
    2023826-2011-00144
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 17, 2011
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    HQL
    PMA / PMN Number
    P030016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO CONSEQUENCES OR IMPACT TO PATIENT. (B)(4) - TEARS, RIPS, HOLES IN DEVICE, DEVICE MATERIAL. EVALUATION METHOD: LENS WORK ORDER SEARCH. RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE LENS OPTIC TORN AND PIECES OF 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: 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. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON INSERTED A 13.2MM MICL 13.2 IMPLANTABLE COLLAMER LENS AND THE LENS TORE. THE LENS WAS REMOVED WITH NO PATIENT INJURY, NO ENLARGED INCISION OR SUTURES. THE BACK-UP LENS WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS HQL STAAR SURGICAL COMPANY MICL 13.2

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR NAVIJECT INJECTOR SYSTEM: LOT NUMBER UNK