BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1530912 · Received October 30, 2009

    Report

    Report Number
    1119421-2009-01031
    Event Type
    Other
    Date Received
    October 30, 2009
    Date of Event
    July 1, 2009
    Report Date
    October 1, 2009
    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
    MD, 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 10/12/2009,10/13/2009, 10/14/2009, 10/16/2009 AND 10/28/2009 BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONAIRE HAS NOT BEEN RECEIVED. (B) (4). (B) (4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON REPORTED THE PT HAD PRESUMED LENTICULAR ASTIGMATISM PRIOR TO SURGERY. THE SURGEON ALSO REPORTED THE PT WAS SEEING A BLURRED SPOT TEMPORALLY THAT WOULD COME AND GO. THE SURGEON WAS TREATING THE PT WITH MEDICATIONS. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS MJP ALCON RESEARCH LTD/HUNTINGTON SN6AT3 10909416

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other PRAVASTATIN| ATACAND| NEXIUM| ASPIRIN| WELLBUTRIN