BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2413121 · Received January 10, 2012

    Report

    Report Number
    2023826-2012-00010
    Event Type
    Injury
    Date Received
    January 10, 2012
    Date of Event
    November 4, 2011
    Report Date
    December 14, 2011
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) SECONDARY SURGERY, (B)(4) UNREACTIVE PUPIL (FIXED). (B)(4) EXCESSIVE. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED AN 13.2 MM VICM13.2 IMPLANTABLE COLLAMER LENS ON (B)(6) 2011 IN PT'S RIGHT EYE. THE LENS WAS EXPLANTED ON (B)(6) 2011 DUE TO EXCESSIVE VAULTING. THE PT ALSO EXPERIENCED A UNREACTIVE (FIXED) PUPIL. THE LENS WAS EXCHANGED FOR A SHORTER LENS. PT'S LAST VISIT BCVA WAS 20/20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL CO. VICM13.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention FOAM TIP PLUNGER: MODEL AND LOT NUMBER - UNK| CARTRIDGE: MODEL AND LOT NUMBER - UNK| INJECTOR: MODEL AND LOT NUMBER - UNK