BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2060900 · Received March 18, 2011

    Report

    Report Number
    1119421-2011-00309
    Event Type
    Other
    Date Received
    March 18, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 3, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. NO SAMPLE WAS RETURNED. ACTION TAKEN: NO FURTHER ACTION IS WARRANTED AT THIS TIME. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED AND FURTHER ACTION WILL BE INITIATED WHEN DEEMED NECESSARY BY THE APPROPRIATE RESPONSIBLE MANAGEMENT PERSONNEL. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 02/17/2011 AND 03/17/2011 BY PHONE, FAX, AND MAIL. ADDITIONAL INFORMATION WAS OBTAINED BY PHONE ON 02/17/2011. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CLINIC DIRECTOR REPORTED A PATIENT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION RELATED TO THE LENS ROTATING 15 DEGREES. HE REPORTED THAT THE SURGEON DOES NOT THINK THE LENS IS DEFECTIVE OR TO BLAME. IN A FOLLOW-UP, THE CLINIC DIRECTOR REPORTED THAT THE PATIENT IS POST-LASIK AND THAT MEASUREMENTS WERE TAKEN WITH DIFFERENT INSTRUMENTS WITH VARYING RESULTS. THE SURGEON STATED THAT THE PATIENT'S TOPOGRAPHY WAS "NOT REGULAR" AND "THIS MAY BE PLAYING A PART". THE SURGEON STATED THAT THE PATIENT WILL HAVE TO WEAR GLASSES FOR NEAR AND THE PATIENT IS NOT UNHAPPY WITH HAVING TO WEAR GLASSES. THE SURGEON WANTED TO SEE IF ROTATING THE LENS WOULD IMPROVE THE UNCORRECTED DISTANCE VISION. HOWEVER, SINCE IT APPEARS THAT ROTATION WOULD NOT HAVE A SIGNIFICANT IMPACT ON THE OUTCOME AND THE PATIENT WOULD STILL BE HYPEROPIC, HAVE A CYLINDRICAL COMPONENT AND BE IN NEED OF GLASSES EVEN IF THE LENS WERE ROTATED, HE HAS DECIDED TO PRESCRIBE GLASSES AS HE IS NOT INTERESTED IN ROTATING, EXCHANGING OR IMPLANTING A SECONDARY IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT4 10970609

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other