BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2231190 · Received August 26, 2011

    Report

    Report Number
    1119421-2011-01054
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    June 7, 2011
    Report Date
    July 27, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORDS 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 INFO. NO FURTHER ACTION IS WARRANTED AT THIS TIME. 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 07/28/2011 BY FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 08/03/2011. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT WHO CAN SEE WELL AT DISTANCE, BUT HAS DECREASED NEAR VISION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. IN A F/U, THE SURGEON REPORTED THE EVENT CONTINUES. IT IS UNK IF THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. MINIMAL POSTERIOR CAPSULE OPACIFICATION (PCO) HAD BEEN NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 11080534

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other VISCOAT| PROVISC