BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2231169 · Received August 26, 2011

    Report

    Report Number
    1119421-2011-01071
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 28, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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. 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 HAS BEEN ONE OTHER SIMILAR COMPLAINT REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 08/01/2011 AND 08/23/2011 BY FAX, PHONE AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PT WAS NOT HAPPY WITH HER NEAR VISION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. SHE STATED THE PT'S BCVA HAS DECREASED, BUT DOES IMPROVE WITH THE USE OF ARTIFICIAL TEARS. THE SURGEON STATED SHE DOES NOT BLAME THE LENS FOR THE DECREASED VISION, BUT SHE THINKS IT IS DUE TO THE PT'S MILD DRY EYE/OCULAR SURFACE DISORDER. SHE REPORTED SHE EXPECTS THE PT'S VISION TO IMPROVE WITH TIME AND BETTER TEAR FILM/OCULAR SURFACE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 10870521

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other