BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF IQ TORIC

    MDR report key: 2163610 · Received June 8, 2011

    Report

    Report Number
    1119421-2011-00722
    Event Type
    Other
    Date Received
    June 8, 2011
    Date of Event
    February 23, 2011
    Report Date
    May 9, 2011
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    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. 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. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 05/18/2011 AND 05/26/2011 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 05/27/2011. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT ONE DAY FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES, SHE NOTICED FLICKERING OF LIGHT (IN HER RIGHT EYE), HER DISTANT VISION IS BLURRY AND HER EYES FEEL WEAK, HURT "LIKE THEY'RE WINDBLOWN" AND FEEL "LIKE THERE'S SAND IN THEM IN THE MORNING". THE CONSUMER ALSO STATED THAT AN OPTOMETRIST TOLD HER SHE REMAINS NEAR-SIGHTED. IN A FOLLOW-UP, THE SURGEON REPORTED THE EVENT CONTINUES. IN HER OPINION, THE DEVICE DID NOT CAUSE/CONTRIBUTE TO THE EVENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF IQ TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN6AT3 10989333

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other VISCOAT| SIMVASTATIN| FEXOFENDADINE| NABUMETONE| JANUVIA| CLONIDINE| CARTIA XT| MONARCH HANDPIECE III| MONARCH D CARTRIDGE| PROVISC| NEVANAC (AS NEEDED)| OMEPRAZOLE| INDAPAMIDE| HYDROCHOLOROTHIAZIDE