BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1941845 · Received December 17, 2010

    Report

    Report Number
    1119421-2010-01417
    Event Type
    Other
    Date Received
    December 17, 2010
    Date of Event
    January 1, 2010
    Report Date
    November 18, 2010
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    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 COMPLAINT REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 11/23/2010, 11/30/2010, AND 12/03/2010 BY PHONE, FAX, AND MAIL. ADDITIONAL INFORMATION WAS OBTAINED BY PHONE ON 12/03/2010. A COMPLETED QUESTIONNAIRE HAS NOT BEEN REC'D. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, SHE IS EXPERIENCING BLURRY AND DOUBLE VISION AND HER EYE FEELS SWOLLEN AND HURTS AT TIMES. HER SURGEON INFORMED HER THAT SHE NEEDS MORE TIME TO ADJUST AND GAVE HER PRESCRIPTION GLASSES WHICH DID NOT HELP. SHE BOUGHT A BIGGER FRAME AND IT HAS HELPED A LITTLE. IN A F/U PHONE CALL TO THE SURGEON, HE REPORTED THAT THE PT IS SEEING 20/20 WITH CORRECTION AND NO MEDICAL INTERVENTION IS PLANNED. HE STATED THE IMPLANT SURGERY WAS UNREMARKABLE AND WITHOUT COMPLICATIONS. HE REPORTED THAT HE DOES NOT BLAME THE IOL FOR THE EVENTS. HE PLANS ON FOLLOWING UP WITH THE PT REGARDING HER SYMPTOMS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AT5 10932495

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other