BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2191145 · Received July 29, 2011

    Report

    Report Number
    1119421-2011-00930
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    October 25, 2010
    Report Date
    July 1, 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
    CA, 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 HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 07/06/2011 AND 07/15/2011 BY FAX, MAIL AND PHONE. A COMPLETED QUESTIONAIRE WAS RECEIVED ON 07/20/2011. (B)(4).

    Description of Event or Problem · 1

    AN ATTORNEY REPORTED THAT A CONSUMER WAS IMPLANTED WITH AN INTRAOCULAR LENS (IOL) THAT WAS "INCORRECT FOR HER VISION NEEDS." THE LENS WAS EXCHANGED AND DURING THE PROCEDURE, THERE WAS SIGNIFICANT (UNSPECIFIED) DAMAGE TO HER EYE. F/U INFO WAS RECEIVED FROM THE SURGEON, WHO REPORTS THAT FOLLOWING THE INITIAL IMPLANT, THE CONSUMER HAD A HYPEROPIC RESULT AND BLURRY, UNCORRECTED VISION. IN THE SURGEON'S OPINION, THE IOL DESIGN DID NOT CONTRIBUTE TO THE EVENT. ADDITIONALLY, THE SURGEON REPORTED THE CONSUMER HAD IRIS ATROPHY DUE TO FLOPPY IRIS SYNDROME DURING THE EXCHANGE. FOLLOWING THE LENS EXCHANGE, THE CONSUMER REPORTED PERSISTENT GLARE. IN THE SURGEON'S OPINION, THE IOL DID NOT CAUSE/CONTRIBUTE TO THE EVENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THESE EVENTS. THIS REPORT IS FOR THE INITIAL LENS THAT WAS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60WF 11050707

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention DUOVISC