BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 3183117 · Received June 21, 2013

    Report

    Report Number
    2023826-2013-00519
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    April 8, 2013
    Report Date
    May 28, 2013
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER? NO. LENS NOT RETURNED. EVALUATION METHOD: WORK ORDER SEARCH. RESULTS: 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 AND WORK ORDER SEARCH, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED A LENS IMPLANT CARD FOR A 13.2MM MICL 13.2 IMPLANTABLE COLLAMER LENS. THE FACILITY HAD WRITTEN ON THE CARD "DEFECT/TEAR IN TRAILING HAPTIC (NOTED AFTER IMPLANTATION). THE DEVICE WAS NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED - THE SURGEON STATED THE TRAILING HAPTIC TORE DURING THE LOADING PROCESS BUT WAS NOT NOTED UNTIL THE LENS WAS IN THE EYE. THE LENS WAS REMOVED DURING THE SAME SURGERY, WITH NO PATIENT INJURY. THE BACKUP LENS WAS IMPLANTED. THE LENS WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282701 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL 13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR INJECTOR MODEL MSI-PF| FOAM TIP PLUNGER MODEL FTP| INJECTOR MODEL AND LOT NUMBER UNK| CARTRIDGE MODEL AND LOT NUMBER UNK| CARTRIDGE MODEL SFC-45 FP