BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2070116 · Received April 22, 2011

    Report

    Report Number
    1119421-2011-00471
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 23, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: 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. THE LENS WAS RETURNED WRAPPED IN A WET FOAM LIKE SUBSTANCE. PRODUCT HISTORY RECORDS WERE REVIEWED AND ALL DOCUMENTS INDICATE THE PRODUCT MET RELEASE CRITERIA. AN UNAPPROVED VISCOELASTIC WAS USED. ROOT CAUSE: WHILE WE ARE UNABLE TO DETERMINE THE ORIGIN OF THE DAMAGE, OUR OBSERVATION REASONABLY SUGGESTS THAT IT IS NOT MFG RELATED. DUE TO THE CONDITION OF THE RETURNED SAMPLE, THE DAMAGE IS POTENTIALLY RELATED TO CUSTOMER HANDLING. ACTION TAKEN: INVESTIGATION HAS BEEN COMPLETED BASED ON CURRENT INFO. 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 AT AN ACCEPTABLE LEVEL. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED ON (B)(4) 2011 BY FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON (B)(4) 2011. (B)(4). THIS REPORT WAS MAILED TO FDA ON: (B)(4)2011. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXCHANGED DUE TO UNPLANNED MYOPIA. IN A F/U, IT WAS REPORTED THAT IT IS UNK WHETHER OR NOT THE IOL CAUSED/CONTRIBUTED TO THE EVENT. AN UNAPPROVED VISCOELASTIC WAS USED DURING THE IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT3 10945612

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention HEALON GV