BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2023835 · Received March 8, 2011

    Report

    Report Number
    2023826-2011-00187
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    November 29, 2009
    Report Date
    February 8, 2011
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: (OTHER): LENS WORK ORDER SEARCH. RESULTS (OTHER): A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE SAME WORK ORDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED PT HAD A 13.2MM IMPLANTABLE COLLAMER LENS IMPLANTED IN THE LEFT EYE ON (B)(6) 2009. AS PART OF THE POST MARKET STUDY, THE PT REPORTED EXPERIENCING A POSTERIOR VITREOUS DETACHMENT. THE DOCTOR'S OFFICE WAS CONTACTED. STATED THE DETACHMENT WAS NOTED ON (B)(6) 2009 AND DURATION OF CONDITION WAS APPROX ONE MONTH. THE CONDITION HAS BEEN RESOLVED. THE DOCTOR'S OFFICE REPORTED THE PT SAW FLASHES AND FLOATERS. ALL SYMPTOMS HAVE GONE. PATIENT'S LAST VISIT WAS ON (B)(6) 2010, THE PATIENT'S VISUAL ACUITY WAS 20/25. THE ICL REMAINS IMPLANTED.

    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 46 YR Required Intervention