BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1981207 · Received January 27, 2011

    Report

    Report Number
    1119421-2011-00059
    Event Type
    Other
    Date Received
    January 27, 2011
    Date of Event
    January 1, 2010
    Report Date
    December 28, 2010
    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 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 01/05/2011, 01/11/2011, AND 01/19/2011 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, SHE SEES HALOS AT NIGHT AND CANNOT READ WITHOUT GLASSES BECAUSE, HER VISION IS BLURRY. THE CONSUMER REPORTED THAT HER DISTANCE AND INTERMEDIATE VISION WAS GOOD, BUT SHE CANNOT READ AT ALL WITHOUT HER GLASSES. THE CONSUMER STATED THAT HER SURGEON TOLD HER THAT SHE HAD BROKEN BLOOD VESSELS SOMETIMES CAUSED BY PARTICLES ON THE IOL AND THAT THESE PARTICLES WOULD DISINTEGRATE EVENTUALLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 10870384

    Patients

    Seq Age Sex Outcome Treatment
    1 Other