BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2130498 · Received June 14, 2011

    Report

    Report Number
    2023826-2011-00523
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 18, 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
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED AN 11.5MM (B)(4) IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE ON (B)(6) 2011. ON (B)(6) 2011, AN ANTERIOR SUBCAPSULAR CATARACT WAS NOTED. THE LENS WAS EXPLANTED ON (B)(6) 2011 DUE TO LOW VAULTING. THE LENS WAS EXCHANGED FOR A LONGER LENS. THE PATIENT'S LAST VISIT ON (B)(6) 2011, 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. ICM115V4 NA

    Patients

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