BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 2095684 · Received April 22, 2011

    Report

    Report Number
    1119421-2011-00479
    Event Type
    Other
    Date Received
    April 22, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    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. NO SAMPLE WAS RETURNED. 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 03/24/2011, 03/25/2011, 03/30/2011, 04/12/2011, AND 04/19/2011 BY PHONE, FAX, AND MAIL. ADDITIONAL INFORMATION WAS RECEIVED ON 04/20/2011 BY PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT TWO DAYS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HIS DISTANCE VISION IS "NOT AS CLEAR AS HE EXPECTED" (THE FELLOW EYE IS ALSO IMPLANTED WITH THE SAME MODEL LENS WITH "NO PROBLEMS"). HE REPORTED THAT HE AND HIS SURGEON AGREED THAT THIS EYE WOULD BE SET UP FOR INTERMEDIATE VISION AND THE FELLOW EYE FOR DISTANCE VISION. THE CONSUMER STATED THAT WHILE HE IS ABLE TO SEE HIS COMPUTER SCREEN AND READ WITHOUT GLASSES, HIS DISTANCE VISION IS BLURRIER THAN HE CAN TOLERATE. THE CONSUMER REPORTED THAT HIS SURGEON ADVISED HIM THAT THIS "SET-UP" WOULD TAKE SOME TIME TO GET USED TO, YET THE CONSUMER FEELS HE WILL BE UNABLE TO DO SO. MOREOVER, THE CONSUMER THOUGHT THAT BY INTERMEDIATE, HE WOULD BE ABLE TO SEE AT 10-FOOT, VERSUS THE 3-FOOT VISION RANGE HE HAS NOW. IN A FOLLOW-UP, THE SURGEON REPORTED THAT, AT THE PATIENT'S REQUEST, HE WAS "MADE A -1.00 FOR INTERMEDIATE VISION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF 11066458

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other