BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2192452 · Received July 27, 2011

    Report

    Report Number
    1119421-2011-00926
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    May 24, 2011
    Report Date
    June 1, 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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE ACCOUNT INDICATED USE OF UNAPPROVED LENS/CARTRIDGE/HANDPIECE COMBINATION. ROOT CAUSE: NO ROOT CAUSE COULD BE IDENTIFIED BY THE INVESTIGATION. INFO PROVIDED INDICATED A FAILURE TO FOLLOW THE DIRECTIONS FOR USE. 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 AND AT AN ACCEPTABLE LEVEL. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED ON 06/02/2011 AND 07/01/2011 BY PHONE, FAX, AND MAIL. ADDITIONAL INFO WAS RECEIVED ON 06/27/2011 BY PHONE. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 07/15/2011. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, SHE HEARD THE SURGEON SAY THAT THERE WAS "LACERATION ON THE LENS." THE CUSTOMER REPORTED THAT THE SURGEON DECIDED TO LEAVE THE LENS IN PLACE AS IT WOULD HAVE BEEN RISKY TO REMOVE IT. THE CONSUMER STATED HER VISION IS FINE AT THE MOMENT BUT HAD CONCERN FOR THE FUTURE. IN A F/U, THE CONSUMER FURTHER REPORTED THAT, AT ONE DAY POSTOPERATIVELY, SHE HAD INCREASED PRESSURE (IOL) AND CORNEAL EDEMA, BUT HAS RESOLVED. THEN, AT FOUR WEEKS POSTOPERATIVELY, HER VISION HAS DETERIORATED AND SEES A FLOATER, HAS DIFFICULTY READING STREET SIGNS. SHE ALSO REPORTED HER SURGEON CLARIFIED THAT THE "LACERATION" ON THE LENS WAS A CREASE OR FOLD. IN A F/U, THE SURGEON REPORTED THE EVENTS (INCREASED IOP AND EDEMA) RESOLVED WITH TREATMENT AND THAT THE LENS DID NOT CAUSE/CONTRIBUTE TO THE EVENT. THE SURGEON REPORTED THE "CRACK" NOTED ON THE IOL IS NOT VISUALLY SIGNIFICANT. ADDITIONAL INFO RECEIVED FROM THE SURGEON ALSO INDICATED THE USE OF AN UNAPPROVED LENS/CARTRIDGE/HANDPIECE COMBINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT4 10909504

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention CEFUROTIME| LIDOCAINE| AMVISC| MONARCH HANDPIECE| MONARCH CARTRIDGE| VISCOAT