BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2276556 · Received September 30, 2011

    Report

    Report Number
    1119421-2011-01194
    Event Type
    Injury
    Date Received
    September 30, 2011
    Date of Event
    July 29, 2011
    Report Date
    August 31, 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
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS WAS NOT RETURNED FOR ANALYSIS. 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 08/31/2011 AND 09/06/2011 BY PHONE, FAX, AND MAIL. ADDITIONAL INFO WAS RECEIVED BY PHONE ON 09/06/2011. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 09/15/2011. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT WITH A REFRACTIVE SURPRISE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. IN A FOLLOW-UP, THE SURGEON REPORTED THE LENS WAS REPOSITIONED AND THE EVENT RESOLVED. INFO RECEIVED INDICATED THERE WAS A FORMULATION ERROR, AS WELL AS, AN INCORRECT LENS CONSTANT WAS USED IN THE FORMULA; THE PREOPERATIVE STEEP AXIS CHANGED FROM THE POSTOPERATIVE ONE, AND THE LENS AS 23 DEGREES OFF AXIS. THE SURGEON REPORTED HE COULD NOT EXPLAIN WHAT CAUSED THE LENS TO ROTATE AS HE PLACED IT ON AXIS DURING THE SURGERY. IN THE SURGEON'S OPINION, THE LENS DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT4 11025857

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention