BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2161822 · Received July 8, 2011

    Report

    Report Number
    1119421-2011-00864
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    December 15, 2010
    Report Date
    June 10, 2011
    Manufacturer
    ALCON RESEARCH, LTD./ HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, ONLY THE CARTON AND INSERTS WERE RETURNED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE: THE ROOT CAUSE COULD NOT 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 06/13/2011 BY PHONE, FAX AND MAIL. ADDITIONAL INFORMATION WAS RECEIVED 06/17/2011 BY PHONE. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 06/17/2011. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED HALOS, GHOSTING AND A ROUGH FEELING IN THE EYE FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. SHE HAS SEEN CORNEAL AND RETINAL SPECIALISTS WHO HAVE TOLD HER THAT EVERYTHING IS NORMAL. THE CONSUMER ALSO REPORTED THAT PEOPLE TELL HER THEY SEE A FLICKERING IN THE EYE WHILE TALKING TO HER AND THAT SHE USES A LUBRICANT IN THE EYE FOR THE ROUGH FEELING. FOLLOW-UP INFORMATION WAS RECEIVED FROM THE SURGEON, WHO REPORTED THE EVENT CONTINUES. AN UNAPPROVED VISCOELASTIC WAS USED DURING THE IMPLANT SURGERY. A YAG CAPSULOTOMY WAS PERFORMED 3 MONTHS AFTER THE IMPLANT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./ HUNTINGTON SN6AD1 11054901

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention PROVISC| EPSILON INJECTOR| MONARCH D CARTRIDGE