BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2032431 · Received March 25, 2011

    Report

    Report Number
    1119421-2011-00335
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    May 10, 2010
    Report Date
    February 23, 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
    DE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: 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 IDENTIFY BY THE INVESTIGATION. NO SAMPLE WAS RETURNED. ACTION TAKEN: NO FURTHER ACTION IS WARRANTED AT THIS TIME. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED AND FURTHER ACTION WILL BE INITIATED WHEN DEEMED NECESSARY BY THE APPROPRIATE RESPONSIBLE MANAGEMENT PERSONNEL. THERE HAS BEEN ONE OTHER SIMILAR COMPLAINTS REPORTED IN THE LOT NUMBER WHICH IS FOR THE RELATED FILE. ADD'L INFO WAS REQUESTED ON 02/23/2011, 03/03/2011, AND 03/17/2011 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 03/14/2011. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED POOR READING VISION FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES. IN A FOLLOW-UP, THE SURGEON REPORTED THAT POSTERIOR CAPSULAR OPACIFICATION (PCO) WAS NOTED APPROX FOUR MONTHS FOLLOWING THE SURGERIES AND YAG LASER WAS PERFORMED FOR BOTH EYES. THE SURGEON REPORTED THE PT CONTINUES TO HAVE POOR READING VISION IN LOW LIGHT CONDITIONS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE FOLLOW EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON SN6AD1 10925115

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention AMVISC| MONARCH CARTRIDGE