BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF TORIC

    MDR report key: 1291028 · Received December 19, 2008

    Report

    Report Number
    1119421-2008-01055
    Event Type
    Other
    Date Received
    December 19, 2008
    Date of Event
    October 1, 2008
    Report Date
    December 3, 2008
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    MJP
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED ON 12/05/2008 AND 12/15/2008 BY PHONE, FAX AND MAIL. THE SURGEON WAS UNWILLING TO COMPLETE THE QUESTIONNAIRE, HOWEVER, ADDITIONAL INFO WAS PROVIDED BY PHONE ON 12/15/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT EXPERIENCING GLARE FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE PT DID HAVE GLARE PRIOR TO SURGERY, BUT THE SURGEON THOUGHT IT WAS DUE TO THE CATARACTS. THE PT IS EXTREMELY HAPPY WITH HER VISION. THE SURGEON DOES NOT BELIEVE THAT THE LENSES ARE DEFECTIVE. IN A FOLLOW-UP, IN THE SURGEON'S OPINION, THE DEVICE DID NOT CAUSE/CONTRIBUTE TO THE EVENT. THERE ARE TWO MEDICAL DEVICE REPORTS FOR THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS MJP ALCON RESEARCH, LTD./HUNTINGTON SN60T3 10845173

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other