BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 1914311 · Received November 15, 2010

    Report

    Report Number
    1119421-2010-01259
    Event Type
    Other
    Date Received
    November 15, 2010
    Date of Event
    August 1, 2010
    Report Date
    October 16, 2010
    Manufacturer
    ALCON RESEARCH, LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 11/01/2010 11/02/2010, AND 11/03/2010 BY PHONE, FAX, AND MAIL. ADDITIONAL INFO WAS REC'D IN A FOLLOWUP PHONE CALL ON 11/03/2010. MEDICAL RECORDS WERE REC'D ON 11/03/2010. A COMPLETED QUESTIONNAIRE HAS NOT BEEN REC'D. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. IN A FOLLOW UP PHONE CALL WITH THE SURGEON'S SURGERY COORDINATOR, SHE REPORTED THE IOL WAS 90 DEGREES OFF AXIS FOLLOWING SURGERY. THE SURGERY COORDINATOR ALSO REPORTED THAT POSTERIOR CAPSULE OPACIFICATION HAD BEEN NOTED. MEDICAL RECORDS WERE REQUESTED AND REC'D. DURING THE INITIAL POSTOPERATIVE VISITS, THE PT'S VISUAL ACUITY WAS COUNT FINGERS. THE VISUAL ACUITY HAD GRADUALLY IMPROVED, ALTHOUGH THE PT WAS ALSO REPORTING DOUBLE VISION. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. SN6AT5 11006450

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other