BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 2060979 · Received April 1, 2011

    Report

    Report Number
    1119421-2011-00370
    Event Type
    Other
    Date Received
    April 1, 2011
    Date of Event
    March 1, 2010
    Report Date
    March 4, 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
    VA, 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. ACTION TAKEN: NO FURTHER ACTION IS NOT 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 HAVE BEEN NO OTHER SIMILAR COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 03/09/2011, 03/11/2011, AND 03/28/2011 BY PHONE, FAX, AND MAIL. ADD'L INFO WAS OBTAINED BY PHONE ON 03/09/2011. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT ONE YEAR FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERIES, HE IS SEEING CIRCLES FROM THE IMPLANTS DAY AND NIGHT AND THAT THE LIGHT FROM CARS OR PARKING LOTS MAKE IT DIFFICULT TO DRIVE. HE STATED THAT HE IS STRUGGLING TO DO EVERYDAY TASKS DURING THE DAY BECAUSE OF THE RINGS. HE WAS INFORMED BY HIS SURGEON HE WOULD NOT BE SEEING THE CIRCLES IN THE IMPLANTS WITHIN A SIX MONTH PERIOD. THE CONSUMER ALSO REPORTED THAT, PER HIS SURGEONS' INSTRUCTION, HE TOOK A COURSE ON THE INTERNET THAT WOULD HELP HIM WITH THIS ISSUE, BUT THERE HAS BEEN NO IMPROVEMENT AFTER 25 SESSIONS OF THE COURSE. IN A PHONE FOLLOW-UP, THE SURGICAL COORDINATOR STATED THAT THE SURGEON INFORMS EACH PT ABOUT SEEING THE CIRCLES AFTER IMPLANTATION. SHE REPORTED THAT THE PT HAS DRY EYE AND IS CURRENTLY ON DRY EYE MEDICATIONS. AT THE LAST VISIT, THE SURGEON NOTED SUPERFICIAL PUNCTATE KERATITIS (SPK) AND TOLD THE PT THIS WILL MAKE THE RINGS MORE NOTICEABLE. ADD'L INFO HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD./HUNTINGTON SN6AD3 10870202

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other