BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2023673 · Received March 3, 2011

    Report

    Report Number
    1119421-2011-00272
    Event Type
    Other
    Date Received
    March 3, 2011
    Date of Event
    November 18, 2010
    Report Date
    February 10, 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
    FL, US
    Reporter Occupation
    UNKNOWN

    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. 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 INFO WAS REQUESTED ON 02/10/2011 AND 02/21/2011 BY PHONE, EMAIL, FAX AND MAIL. ADDITIONAL INFO WAS RECEIVED BY PHONE 02/21/2011. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 02/24/2011. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT SHE DID NOT EXPECT TO HAVE TO WEAR GLASSES FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. IN A F/U WITH THE CONSUMER, SHE REPORTED THAT HER DISTANCE VISION IS "GREAT", BUT SHE HAS TO WEAR GLASSES TO READ. PRIOR TO HER SURGERY, SHE WAS WEARING BIFOCALS TO READ; NOW SHE HAS TO HAVE A 250 MAGNIFICATION TO READ. ADDITIONAL INFO WAS RECEIVED FROM THE SURGEON'S CLINICAL COORDINATOR, WHO REPORTS THE OUTCOME OF THE EVENT IS UNK. 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 10903155

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other