BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2061045 · Received April 13, 2011

    Report

    Report Number
    1119421-2011-00402
    Event Type
    Other
    Date Received
    April 13, 2011
    Date of Event
    December 22, 2010
    Report Date
    March 14, 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
    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 IDENTIFIED BY THE INVESTIGATION. NO SAMPLE WAS RETURNED. CUSTOMER INDICATED THAT AN UNAPPROVED HANDPIECE WAS USED WITH THE LENS/CARTRIDGE COMBINATION. 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 MGMT PERSONNEL. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED ON 03/17/2011 BY FAX AND MAIL. A COMPLETED QUESTIONAIRE WAS RECEIVED ON (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HIS DISTANCE VISION WAS GOOD, BUT FROM TWO TO FOUR FEET HIS VISION IS BLURRY AND READING IS A PROBLEM. F/U INFO WAS RECEIVED FROM THE SURGEON WHO REPORTED THE PT HAS A HISTORY OF HYPERLIPIDEMIA, HEADACHES, ROSACEA, ARTHRITIS, DRY EYE HIATAL HERNIA AND GLAUCOMA SUSPECTED. AN UNAPPROVED HANDPIECE WAS USED WITH THE LENS/CARTRIDGE COMBINATION DURING THE SURGICAL PROCEDURE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD1 10872439

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other ISTALOL| MONARCH "B" CARTRIDGE| DUOVISC| LUMIGAN| MONARCH III HANDPIECE