BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2549635 · Received April 18, 2012

    Report

    Report Number
    1119421-2012-00490
    Event Type
    Injury
    Date Received
    April 18, 2012
    Date of Event
    January 1, 2012
    Report Date
    March 19, 2012
    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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE ROOT CAUSE COULD NOT BE IDENTIFIED BY THE INVESTIGATION. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 04/04/2012 AND 04/11/2012 BY PHONE, FAX, AND MAIL. THE SURGEON IS UNWILLING TO COMPLETE THE QUESTIONNAIRE. ADDITIONAL INFORMATION WAS PROVIDED IN FOLLOW UP PHONE CALLS ON 04/03/2012, 04/04/2012 AND 04/16/2012. NO FURTHER INFORMATION IS EXPECTED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOUR YEARS FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HIS VISION IS FOGGY. IN A FOLLOW UP PHONE CALL WITH THE CONSUMER, HE REPORTED THAT HE HAD A LASIK PROCEDURE PERFORMED FOR HIS FELLOW EYE ONLY. HIS VISION IS MUCH BETTER FOLLOWING THE LASIK PROCEDURE. THE CONSUMER REPORTED THAT THE SURGEON DID NOT FEEL THIS EYE REQUIRED A LASIK PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON, WHO REPORTED THE PATIENT DID NOT HAVE A LASIK PROCEDURE BUT HAD A YAG CAPSULOTOMY PERFORMED FOR THE RIGHT EYE ONLY. THE SURGEON DOES NOT FEEL THERE IS ANYTHING WRONG WITH THE LENSES. THE SURGEON IS UNWILLING TO COMPLETE THE QUESTIONNAIRE. THERE ARE TWO MEDICAL 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 INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SA60AT 10704282

    Patients

    Seq Age Sex Outcome Treatment
    1 Other