BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE 2 BRAND CONTACT LENSES

    MDR report key: 3201431 · Received June 28, 2013

    Report

    Report Number
    1033553-2013-00080
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    July 1, 2012
    Report Date
    June 28, 2013
    Manufacturer
    VISTAKON
    Product Code
    LPL
    PMA / PMN Number
    N18033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTED ADDITIONAL INFORMATION FROM AMO. NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME. IF ADDITIONAL MEDICAL OR PRODUCT INFORMATION IS RECEIVED,WE WILL REPORT IT WITHIN 30 DAYS OF RECEIPT. MDR REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN FRANCHISE MANAGEMENT REVIEW MEETINGS.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION FOUND ON A SEARCH OF THE MAUDE DATABASE ON 05/31/2013 FOR THE PERIOD 12/01/2011 THROUGH 05/31/2013. THIS INFORMATION WAS REPORTED TO THE FDA ON (B)(4) 2012 BY ADVANCED MEDICAL OPTICS. AMO'S MDR #: 3004537773-2012-00010. "A (B) (6) FEMALE PATIENT REPORTED SHE EXPERIENCED A BACTERIAL EYE INFECTION WHICH WAS DIAGNOSED AS A CORNEAL ULCER WHILE INCLUDING COMPLETE MULTIPURPOSE SOLUTION EASY RUB IN HER LENS CARE REGIMEN. SHE INDICATED THAT THER SYMPTOMS WERE PHOTOPHOBIA, DRYNESS, IRRITATION AND A LITTLE REDNESS IN THE RIGHT EYE. SHE SOUGHT MEDICAL TREATMENT ON (B) (6) 2012 AND WAS PRESCRIBED CIPROFLOXACIN TO BE USED EVERY HOUR THE FIRST DAY, DECREASED TO EVERY 2 HOURS THE NEXT DAY AND 4 TIMES A DAY FOR THE REMAINING SOLUTION. A CULTURE WAS NOT OBTAINED. MEDICAL RECORDS FROM THE EYE CARE PROFESSIONAL CONFIRMED A CORNEAL ULCER; ADDITIONAL SYMPTOMS OF EPIPHORA, HYPEREMIA, AND CORNEAL OPACITY WERE ALSO NOTED. PRESCRIBED CILOXAN AND BROMDAY. PATIENT SEEN THREE TIMES WITH LAST OFFICE VISIT ON (B)(6) 2012. THE CORNEA HAS SCARS, BUT PATIENT'S VISUAL ACUITY WAS NOT AFFECTED. CONTACT LENS SOLUTION USED WAS NOT MENTIONED IN MEDICAL RECORDS AND NO CAUSALITY ASSESSMENT WAS PROVIDED. THE PATIENT WEARS ACUVUE 2 LENSES ON A DAILY WEAR BASIS DISCARDING THEM EVERY 2 OR 3 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296849 ACUVUE 2 BRAND CONTACT LENSES SOFT CONTACT LENS LPL VISTAKON NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R COMPLETE MULTIPURPOSE SOLUTION EASY RUB