BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1841632 · Received September 16, 2010

    Report

    Report Number
    1119421-2010-01010
    Event Type
    Injury
    Date Received
    September 16, 2010
    Date of Event
    January 1, 2009
    Report Date
    August 17, 2010
    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
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 08/17/2010 AND 08/18/2010 BY PHONE, FAX, AND MAIL. ADDITIONAL INFORMATION WAS RECEIVED ON 08/17/2010 BY PHONE; MEDICAL RECORDS WERE RECEIVED ON 08/27/2010. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "VISION IS NOT SHARP" (BLURRED VISION); "SHADOWS AROUND IMAGES" (VISION, IMPAIRED). PRODUCT PROBLEM(S): "NONE REPORTED" (NO INFORMATION [IOL (INTRAOCULAR LENS) IMPLANT]). A CONSUMER REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HER VISION IS NOT SHARP. MEDICAL RECORDS WERE REQUESTED AND RECEIVED. FOLLOWING IMPLANT SURGERY, THE CONSUMER REPORTED HAVING A FOREIGN BODY SENSATION. READING WAS BETTER WITH THE RIGHT EYE; DISTANCE VISION WAS BETTER WITH THE LEFT EYE. FIVE MONTHS FOLLOWING THE SURGERY, SHE REPORTED HER VISION WAS NOT SHARP, EVEN WITH GOOD LIGHTING. IN THE MONTHS FOLLOWING, SHE REPORTED SHADOWS WHICH EVENTUALLY IMPROVED WITH GLASSES. SHE UNDERWENT A LASIK PROCEDURE AND REPORTED THAT EVERYTHING WAS "FUZZY" AFTERWARDS. NEARLY ONE YEAR FOLLOWING THE PROCEDURE, A YAG TREATMENTS WAS PERFORMED, AFTER WHICH SHE REPORTED STARBURSTS WHILE DRIVING AT NIGHT, HER VISUAL ACUITY WAS NOT ANY BETTER AND HER PRESCRIPTION GLASSES WERE NOT AS SHARP. SHE WAS PRESCRIBED EYE DROPS WHICH SHE STATED MADE HER EYES FEEL BAD. AT 17 MONTHS POSTOPERATIVELY, SHE REPORTED DRY EYES WHICH CAUSED HER VISION TO BE BLURRY AND STATED THAT MEDICATIONS PRESCRIBED WERE NOT 'DOING THE ENTIRE JOB'. PUNCTUAL PLUGS WERE PLACED BILATERALLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. 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 10870297

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention