BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1545591 · Received November 23, 2009

    Report

    Report Number
    1119421-2009-01134
    Event Type
    Injury
    Date Received
    November 23, 2009
    Date of Event
    July 18, 2009
    Report Date
    October 26, 2009
    Manufacturer
    ALCON RESEARCH LTD. / HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAS BEEN ONE OTHER SIMILAR COMPLAINT REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 10/28/2009 AND 11/04/2009 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 11/04/2009. (B) (4). (B) (4). (B) (4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED EXPERIENCING BLURRY DISTANCE AND INTERMEDIATE VISION FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. HE HAS BEEN GIVEN PRESCRIPTION GLASSES FOR DISTANCE. HE ALSO REPORTED THAT TWO LASIK PROCEDURES HAVE BEEN DONE WITH LITTLE IMPROVEMENT AND FLOATERS IN HIS VISION. IN A FOLLOW-UP, THE SURGEON CONFIRMED THAT LASIK WAS PERFORMED AND THE EVENT CONTINUES. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH LTD. / HUNTINGTON SA60D3 10713143

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DUOVISC| SYSTANE