BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2023705 · Received February 24, 2011

    Report

    Report Number
    1119421-2011-00197
    Event Type
    Other
    Date Received
    February 24, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 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
    PA, 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. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. 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. ADDITIONAL INFORMATION WAS REQUESTED ON 02/04/2011 AND 02/11/2011 BY PHONE, FAX, AND MAIL. ADDITIONAL INFORMATION WAS OBTAINED BY PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER'S HUSBAND REPORTED THAT APPROXIMATELY TEN MONTHS FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES, HIS WIFE'S EYES "HAVE NOT TOTALLY CLEARED AND THEY MEASURE 20/50" AND THAT THIS RESULT IS NOT SATISFACTORY. THE HUSBAND ALSO STATED THAT HIS WIFE HAS BEEN EVALUATED SEVERAL TIMES WITH NO CHANGES AND THAT MOST RECENTLY, HER RETINAS WERE EVALUATED WITH NO PROBLEMS DETECTED. IN A FOLLOW-UP THE SURGEON REPORTED THAT HE DOES NOT BELIEVE THIS IS AN ISSUE WITH THE LENS, RATHER A NEURAL ADAPTATION ISSUE. HE REPORTED THAT THE PATIENT HAS TRACE HAZE, GLARE AND "SMUDGY" VISION. SHE HAS NO RESIDUAL ASTIGMATISM AND THAT PREOPERATIVELY, SHE WAS A HIGH HYPEROPE. THE SURGEON REPORTED THAT THE PATIENT HAS SEEN A RETINAL SPECIALIST AND EVERYTHING "LOOKS FINE". THE SURGEON REPORTED THAT HE CONTINUES TO MONITOR THE PATIENT. 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 11019301

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other