BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2251109 · Received June 24, 2011

    Report

    Report Number
    1119421-2011-00795
    Event Type
    Injury
    Date Received
    June 24, 2011
    Date of Event
    June 1, 2009
    Report Date
    May 25, 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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: 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 INFORMATION. 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 HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 05/25/2011, 05/27/201, AND 06/09/2011 BY PHONE, FAX, AND MAIL. ADDITIONAL INFORMATION WAS RECEIVED IN A FOLLOW UP PHONE CALL WITH THE SURGEON ON 05/26/2011. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HE HAS BLURRY VISION AT WORKING DISTANCE. HE IS UNABLE TO SEE HIS COMPUTER SCREEN CLEARLY OR ANYTHING ON HIS DESK. THE CONSUMER REPORTED HIS SURGEON HAS PRESCRIBED GLASSES WHICH HAVE HELPED. THE CONSUMER REPORTED HE WAS NOT SATISFIED BECAUSE HE THOUGHT HE WOULD NO LONGER NEED TO WEAR GLASSES. IN A FOLLOW UP PHONE CALL WITH THE SURGEON, IT WAS REPORTED THAT THE SURGEON DOES NOT BLAME THE LENSES FOR THE CONSUMER'S ISSUES. THE SURGEON STATED THE CONSUMER WAS NOT SATISFIED WITH HIS VISION AT THE RANGE HE LIKES TO WORK. THE SURGEON REPORTED THAT HE HAD OPTIMIZED THIS CONSUMER COMPLETELY, INCLUDING BILATERAL YAG LASER CAPSULOTOMIES. THE SURGEON REPORTED THE CONSUMER HAD GOOD DISTANCE AND VERY NEAR VISION AND THAT GLASSES HAD BEEN PRESCRIBED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. 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 SN6AD1 10900819

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention