BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2023678 · Received March 3, 2011

    Report

    Report Number
    1119421-2011-00268
    Event Type
    Injury
    Date Received
    March 3, 2011
    Date of Event
    December 23, 2010
    Report Date
    February 9, 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
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVALUATION: THE PRODUCT WAS RETURNED FOR ANALYSIS, THE REPORTED COMPLAINT COULD NOT BE VERIFIED THE OPTIC IS TOO DAMAGED TO CONDUCT A CHECK FOR THE OPTICAL RESOLUTION OR THE DIOPTER OF THE LENS. THE PRODUCT WAS RETURNED AND DAMAGED WAS OBSERVED. AN APPROVED CARTRIDGE WAS USED. HOWEVER, AN UNAPPROVED VISCOELASTIC WAS USED, WHICH IS NOT QUALIFIED FOR USE WITH THIS LENS/CARTRIDGE COMBINATION. ROOT CAUSE. WHILE WE ARE UNABLE TO DETERMINE THE ORIGIN OF THE DAMAGE, OUR OBSERVATION REASONABLY SUGGESTS THAT IT IS NOT MANUFACTURING RELATED. DUE TO THE CONDITION OF THE RETURNED SAMPLE, THE DAMAGE IS POTENTIALLY RELATED TO CUSTOMER HANDLING. INFORMATION PROVIDED INDICATED A FAILURE TO FOLLOW THE DIRECTIONS FOR USE, UNAPPROVED VISCOELASTIC USED. ACTION TAKEN: INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFORMATION. CONCLUSION: BASED ON OUR CURRENT TRACKING, THERE ARE NO ADVERSE TRENDS FOR THIS REPORTED COMPLAINT AND BASED ON THESE FINDINGS THE RESIDUAL RISK REMAINS UNCHANGED AND AT AN ACCEPTABLE LEVEL. THIS REPORT WAS MAILED TO FDA ON 07/22/2011. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS 2011-03086.

    Additional Manufacturer Narrative · 0

    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. DEVICE CODE: 1670 (USE OF DEVICE ISSUE) LABELED. THIS REPORT WAS MAILED TO FDA ON 04/08/2011. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON. THE LENS WAS EXCHANGED AND THE PATIENT IS DOING "FINE" FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON, WHO REPORTS THAT THE EVENT CONTINUES. THE PATIENT NEEDS GLASSES. AN UNAPPROVED VISCOELASTIC WAS USED DURING THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE: NO LOT/SERIAL NUMBER OR SAMPLE WAS RETURNED BY THE CUSTOMER. NO ROOT CAUSE CAN BE DETERMINED AT THIS TIME. 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. ADDITIONAL INFORMATION WAS REQUESTED 02/11/2011 AND 02/28/2011 BY FAX, MAIL AND PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED HAVING A PATIENT WITH RESIDUAL ASTIGMATISM FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303163 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT4 10870908

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Other| R HEALON