BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 3841834 · Received May 30, 2014

    Report

    Report Number
    2023826-2014-00407
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 8, 2014
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION CODES: METHOD (OTHER): WORK ORDER SEARCH RESULTS (OTHER): A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. THE RETURNED PRODUCT WAS VISUALLY INSPECTED BUT WAS UNABLE TO EVALUATE DUE TO THE RETURNED CONDITION - THERE WAS DRIED SURGICAL RESIDUE/FIBERS ON THE LENS SURFACE. 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 12.6MM MICL12.6 IMPLANTABLE COLLAMER LENS INTO THE PATIENT'S LEFT EYE (OS) BUT NOTED THE LENS WAS TOO LONG. THE LENS WAS REMOVED DURING THE SAME SURGERY WITH NO PATIENT INJURY, NO INCISION ENLARGEMENT OR SUTURES. THE SURGEON INSERTED A SMALLER LENS (MICL12.1) BUT THE LENS WOULD NOT LAY PROPERLY IN THE EYE AND WAS REMOVED - SEE MFR REPORT # 2023826-2014-00408. ANOTHER MICL12.1 WAS IMPLANTED WITH NO PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319639 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY MICL 12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR CARTRIDGE MODEL SFC-45 FP - LOT NUMBER UNK| FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK| INJECTOR MODEL AND LOT NUMBER UNK