BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2334617 · Received November 7, 2011

    Report

    Report Number
    1119421-2011-01340
    Event Type
    Injury
    Date Received
    November 7, 2011
    Date of Event
    September 1, 2011
    Report Date
    October 7, 2011
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE ROOT CAUSE COULD NOT BE IDENTIFIED BY THE INVESTIGATION. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 10/12/2011 AND 10/25/2011 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 10/25/2011. MEDICAL RECORDS WERE RECEIVED ON 10/13/2011. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES. THE SURGEON REPORTED THE INTENDED AXIS POSITION FOR THE LENS WAS 178 DEGREES AND THE CURRENT AXIS POSITION WAS 5 DEGREES. THE SURGEON REPORTED THE USE OF AN UNAPPROVED VISCOELASTIC. IN A FOLLOW UP, THE SURGEON REPORTED THE EVENT CONTINUES. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN6AT3 12050308

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other MONARCH HANDPIECE| STAARVISC| MONARCH B CARTRIDGE