BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2191130 · Received July 29, 2011

    Report

    Report Number
    1119421-2011-00941
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 30, 2011
    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
    WY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. ACTION TAKEN: INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFO. CONCLUSION: BASED ON OUR CURRENT TRACKING, THERE ARE NO ADVERSE TRENDS FOR THIS REPORTED COMPLAINT AND BASED ON THESE FINDINGS THE RESIDUAL RISK REMAINS UNCHANGED AND AT AN ACCEPTABLE LEVEL. THERE HAS BEEN ONE OTHER SIMILAR COMPLAINT REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 07/01/2011, 07/13/2011, AND 07/14/2011 BY PHONE, FAX AND MAIL. ADD'L INFO WAS RECEIVED IN A F/U PHONE CALL ON 07/19/2011. A COMPLETED QUESTIONAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER'S WIFE REPORTED THAT HER HUSBAND HAS BLURRY DISTANCE VISION FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES. SHE REPORTED THAT HER HUSBAND'S VISION HAS NOT GOTTEN ANY BETTER THAN BEFORE THE SURGERY. THE WIFE REPORTED HER HUSBAND HAS HAD BOTH CORNEAS "SHAVED." IN A F/U PHONE CALL WITH THE CONSUMER, HE REPORTED THAT EVERYTHING IN THE DISTANCE PAST TEN FEET IS BLURRY. HIS RIGHT EYE IS WORSE THAN THE LEFT. WHEN LOOKING AT LIGHTS THEY SEEM TO FLARE OUT. WHEN DRIVING AND LOOKING AT THE STRIPED LINE ON THE HIGHWAY, IF THE GROUND IS WET, LIGHTS SEEM TO BOUNCE. ADD'L INFO HAS BEEN REQUESTED. THERE ARE TWO MED DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 10870502

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention OPTIV| UNK GLAUCOMA MEDICATION