BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 4820232 · Received June 4, 2015

    Report

    Report Number
    2023826-2015-00166
    Event Type
    Injury
    Date Received
    June 4, 2015
    Report Date
    January 26, 2015
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A RESUBMISSION OF THE INITIAL MDR PER FDA REQUEST.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THROUGH SOCIAL MEDIA THE SURGEON IMPLANTED AN ICL IMPLANTABLE COLLAMER LENS IN HIS RIGHT EYE (OD). THE PATIENT REPORTED THREE DAYS POST-OP, HE HAD BLURRY VISION AND COULDN'T READ SMALL PRINT. THE PATIENT REPORTED LARGE LETTERS ARE OK BUT STILL FUZZY AND NOT AS CRISP LIKE WHEN HE WORE CONTACT LENSES. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363906 VISIAN ICL (IMPLANTABLE COLLAMER LENS) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Male