BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2231172 · Received August 26, 2011

    Report

    Report Number
    1119421-2011-01066
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    October 30, 2008
    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
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    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 08/01/2011 AND 08/24/2011 BY FAX, PHONE AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 08/16/2011. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT SHE "WAS NOT ABLE TO SEE HER COMPUTER" AND THAT SHE "HAD TO TAKE MANY BREAKS IN BETWEEN" FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. IN FOLLOW-UP, THE SURGEON STATED THE CONSUMER'S VISUAL SYMPTOMS WAS DUE TO MILD FORME FRUSLE KERATOCONUS. THIS IS THE FIRST MEDICAL DEVICE REPORT ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE FIRST EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH. LTD. / HUNTINGTON NS6AD3 10775998

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other