BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2001115 · Received February 16, 2011

    Report

    Report Number
    1119421-2011-00116
    Event Type
    Other
    Date Received
    February 16, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 17, 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 INFO WAS REQUESTED ON 01/24/2011, 01/26/2011, AND 02/09/2011 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A TECH REPORTED A PT WITH AN UNEXPECTED POSTOPERATIVE REFRACTION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE TECH REPORTED THE PT HAD MORE ASTIGMATISM THAN BEFORE THE PROCEDURE. SHE REPORTED THE SURGEON DOES NOT FEEL THE IOL WAS DEFECTIVE, BUT DOES NOT HAVE AN EXPLANATION FOR THE REFRACTIVE SURPRISE. IN A FOLLOW UP PHONE CALL WITH THE TECH, SHE REPORTED THE CAUSE OF THE REFRACTIVE SURPRISE WAS THE IOL NOT BEING ALIGNED WITH THE POSTOPERATIVE STEEP MERIDIAN. THE TECH REPORTED THE INTENDED AND CURRENT ORIENTATION OF THE IOL WAS 90 DEGREES, SO THE IOL DID NOT ROTATE. 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. / HUNTINGTON SN6AT3 10870895

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other