BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2452303 · Received February 3, 2012

    Report

    Report Number
    2023826-2012-00085
    Event Type
    Malfunction
    Date Received
    February 3, 2012
    Date of Event
    January 9, 2012
    Report Date
    January 24, 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
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: RESULTS - VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND NO VISIBLE DAMAGE TO THE LENS. LENS WAS RETURNED IN LIQUID. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED, THE SURGEON INSERTED A MICL 12.6MM IMPLANTABLE COLLAMER LENS IN THE PATIENT RIGHT EYE. AFTER LENS WAS INSERTED, THE SURGEON DID NOT LIKE THE WAY THE LENS WAS SITTING IN THE PATIENT'S EYE. DECIDED TO REMOVE THE LENS AND USE THE BACKUP LENS INSTEAD, SAME MODEL AND SIZE. THE INCISION WAS NOT ENLARGED AND NO SUTURE WAS USED. NO PATIENT INJURY. PATIENT IS DOING WELL. THERE WAS NO MALFUNCTION, IT WAS JUST SURGEON'S DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS HQL STAAR SURGICAL CO. MICL12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR FOAM TIP PLUNGER: MODEL| INJECTOR: MODEL MSI-PF| LOT NUMBER UNK| CARTRIDGE: MODEL SFC-45 FP| LOT NUMBER UNK| LOT NUMBER: UNK