BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF TORIC

    MDR report key: 1821704 · Received August 27, 2010

    Report

    Report Number
    1119421-2010-00946
    Event Type
    Other
    Date Received
    August 27, 2010
    Date of Event
    January 1, 2010
    Report Date
    July 28, 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
    CA
    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. A COMPANY OPHTHALMOLOGIST REVIEWED THE CALCULATIONS AND DISCUSSED WITH THE SURGEON THAT A POSSIBLE CAUSE OF THE REFRACTIVE SURPRISE WAS A HIGH TORIC CORNEA WITH MEASUREMENT VARIABILITY AND CROSS CYLINDERS. ADDITIONAL INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "REFRACTIVE SURPRISE" (POSTOPERATIVE REFRACTION, UNEXPECTED). PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFO [IOL (INTRAOCULAR LENS) IMPLANT]). A SURGEON REPORTED A PT WITH A REFRACTIVE SURPRISE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. IN A FOLLOW-UP, THE SURGEON DOES NOT FEEL THE IOL IS DEFECTIVE. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60T9 10970732

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other