BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 2023736 · Received February 24, 2011

    Report

    Report Number
    1119421-2011-00187
    Event Type
    Other
    Date Received
    February 24, 2011
    Date of Event
    January 1, 2007
    Report Date
    January 25, 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
    TX, US
    Reporter Occupation
    OTHER

    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: NO FURTHER ACTION IS WARRANTED AT THIS TIME. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED AND FURTHER ACTION WILL BE INITIATED WHEN DEEMED NECESSARY BY THE APPROPRIATE RESPONSIBLE MANAGEMENT PERSONNEL. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 02/22/2011 BY FAX AND MAIL. MEDICAL RECORDS WERE RECEIVED ON 01/25/2011. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A TECHNICIAN REPORTED, BY MEDICAL RECORDS, THAT APPROXIMATELY NINE MONTHS FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES, THE PATIENT SEES "WAVES" IN BOTH EYES, BUT VISUAL ACUITIES ARE "ABOUT THE SAME". AT APPROXIMATELY 18 MONTHS POSTOPERATIVELY, HE REPORTED SEEING A "WAVY LINE", BUT WHEN HE TURNS HIS HEAD EVERYTHING STRAIGHTENS UP, BUT THEN VERTIGO KICKS IN". AT APPROXIMATELY 29 MONTHS POSTOPERATIVELY, HE REPORTED THAT HE HAS INTERMITTENT DOUBLE VISION WHEN TRYING TO READ THE PRINT ON TV. AT APPROXIMATELY 37 MONTHS POSTOPERATIVE, THE WAVY VISION CONTINUES AND THE CONSUMER EXPERIENCES CONSTANT PAIN AND HAS TROUBLE READING. IN A FOLLOW-UP, THE TECHNICIAN REPORTED THAT THE PATIENT HAS MAJOR RETINAL PROBLEMS AND HAS REFUSED TO SEE A RETINAL SPECIALIST THE PAST YEAR. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE. THE REPORT FOR THE RIGHT EYE HAS BEEN PREVIOUSLY SUBMITTED UNDER MFR REPORT # 1119421-2010-00226.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60AT 10731483

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other SERTALINE| TORPOL| NEXIUM| ZETIA| LISINOPRIL/HYDROCHIOROTHIAZIDE| LIPITOR