BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2051061 · Received April 5, 2011

    Report

    Report Number
    2023826-2011-00235
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    October 15, 2010
    Report Date
    March 9, 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
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(3) - SECONDARY SURGERY, ENDOTHELIAL CELL LOSS. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON IMPLANTED AN 11.5MM ICM115V4 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S RIGHT EYE ON (B)(6) 2009. THE LENS WAS EXPLANTED ON (B)(6) 2010 DUE TO SIGNIFICANT REDUCTION OF ENDOTHELIAL CELL LOSS. ON (B)(6) 2009, PRE-OPERATIVE VALUE WAS 3369 CELLS/MM. ON (B)(6) 2010, POST-OPERATIVE VALUE WAS 1089 CELLS/MM. NO OTHER LENS WAS IMPLANTED, PT WEARS CONTACT LENS AFTER REMOVING ICL. PATIENT'S LAST VISIT ON (B)(6) 2010, BCVA 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 28 YR Required Intervention FOAM TIP PLUNGER: MODEL AND LOT NUMBER - UNK| INJECTOR: MODEL AND LOT NUMBER - UNK| CARTRIDGE: MODEL AND LOT NUMBER - UNK