BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2000755 · Received February 17, 2011

    Report

    Report Number
    1119421-2011-00124
    Event Type
    Injury
    Date Received
    February 17, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 18, 2011
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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. AN UNAPPROVED VISCOELASTIC WAS USED DURING THE SURGICAL PROCEDURE. ADDITIONAL INFO WAS REQUESTED ON 01/28/2011 BY FAX AND MAIL. ADDITIONAL INFO WAS RECEIVED IN FOLLOW UP PHONE CALL ON 01/26/2011. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 02/11/2011. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXCHANGED DUE TO AN UNEXPECTED POSTOPERATIVE REFRACTION. IN A FOLLOW UP PHONE CALL WITH THE NURSE, SHE REPORTED THE PT WAS DOING WELL FOLLOWING THE EXCHANGE. THE NURSE REPORTED THE PT HAD NOT BEEN HAPPY WITH HIS VISION PRIOR TO THE EXCHANGE PROCEDURE. THE IOL WAS EXCHANGED FOR THE SAME MODEL, DIFFERENT POWER LENS. IN A FOLLOW UP, THE SURGEON REPORTED THE UNEXPECTED POSTOPERATIVE REFRACTION WAS UNACCEPTABLE SINCE DISTANCE VISION WAS PLANNED. THE EVENT RESOLVED WITH TREATMENT. AN UNAPPROVED VISCOELASTIC WAS USED DURING THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT3 11034144

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention HA