BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 1632742 · Received March 5, 2010

    Report

    Report Number
    2023826-2010-00216
    Event Type
    Other
    Date Received
    March 5, 2010
    Date of Event
    January 25, 2010
    Report Date
    February 8, 2010
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), LENS INSERTED UPSIDE DOWN: EVAL RESULTS - (OTHER): VISUAL INSPECTION OF THE RETURNED PRODUCT SHOWED EVIDENCE OF A CLEAR SURGICAL RESIDUE, HOWEVER, THERE WAS NO VISIBLE DAMAGE OBSERVED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON INSERTED THE MICL13.2 IMPLANTABLE COLLAMER LENS UPSIDE DOWN DUE TO A LOADING ERROR. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL CO. MICL13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR INJECTOR: MODEL UNK, LOT # UNK| CARTRIDGE: MODEL UNK, LOT # UNK| FOAM TIP PLUNGER: MODEL, LOT # UNK