BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1841491 · Received September 16, 2010

    Report

    Report Number
    2023826-2010-00929
    Event Type
    Malfunction
    Date Received
    September 16, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 19, 2010
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND NO VISIBLE DAMAGE TO THE LENS. THERE WAS EVIDENCE OF CLEAR SURGICAL RESIDUE ON PRODUCT. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY AND THE EVAL OF THE RETURNED PRODUCT, IT WAS DETERMINED THAT THE ROOT CAUSE OF THIS EVENT WAS DUE TO TECHNICAL LOADING ERROR. (B)(4).

    Description of Event or Problem · 1

    THE RPTR STATED THE SURGEON INSERTED A MICL 12.6MM IMPLANTABLE COLLAMER LENS. LENS WAS INSERTED INTO THE EYE, BUT IT DID NOT UNFOLD. LENS WAS REMOVED WITH NO PT INJURY AND BACKUP LENS WAS IMPLANTED. THE RPTR STATED THE CAUSE OF THIS INCIDENT WAS DUE TO LOADING TECHNIQUE BY THE TECH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR INJECTOR: MODEL - MSI-PF AND LOT NUMBER UNK| CARTRIDGE: MODEL SFC-45 FP AND LOT NUMBER UNK| FORM TIP PLUNGER: MODEL AND LOT NUMBER UNK