BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1833868 · Received September 8, 2010

    Report

    Report Number
    1119421-2010-00994
    Event Type
    Other
    Date Received
    September 8, 2010
    Date of Event
    July 29, 2010
    Report Date
    August 9, 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
    PA, 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 HAS BEEN ONE OTHER COMPLAINT REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 8/9/10 AND 8/11/10 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONAIRE WAS RECEIVED ON 8/25/10. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "MYOPIC REFRACTIVE SURPRISE" (POSTOPERATIVE REFRACTION, UNEXPECTED). PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFO [IOL (INTRAOCULAR LENS) IMPLANT]). A SURGEON REPORTED A PT WITH A MYOPIC REFRACTIVE SURPRISE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON STATED THAT BOTH HE AND THE PT ARE SATISFIED WITH THE OUTCOME AS THIS WILL ALLOW FOR SLIGHT MONOVISION AFFECT WITH IMPROVED INTERMEDIATE VISION. IN A F/U, THE SURGEON REPORTED THAT THERE WILL BE NO MEDICAL OR SURGICAL INTERVENTION PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AT4 10966968

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other VISCOELASTIC