BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS FOR ASTIGMATISM

    MDR report key: 6530829 · Received April 28, 2017

    Report

    Report Number
    1057985-2017-00061
    Event Type
    Injury
    Date Received
    April 28, 2017
    Date of Event
    February 7, 2017
    Report Date
    April 6, 2017
    Manufacturer
    JOHNSON & JOHNSON VISION CARE, INC. ¿ US
    Product Code
    LPM
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2017 A PATIENT (PT) CALLED TO REPORT A CURRENT ISSUE WITH HIS/HER OASYS FOR ASTIGMATISM BRAND CONTACT LENSES. DURING THAT TELEPHONE CONVERSATION WITH THE PT HE/SHE REPORTED A DIAGNOSIS OF CORNEAL ULCER IN THE LEFT EYE. THE PT REPORTS A TWO WEEK WEAR SCHEDULE AND DOES NOT SLEEP IN THE LENSES. THE SUSPECT LENS WAS DISCARDED. ON (B)(6) 2017 A CALL WAS PLACED TO THE PTS TREATING EYE CARE PROVIDER¿S OFFICE (ECP) AND A REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION: THE PT WAS SEEN ON (B)(6) 2017 AND DIAGNOSED WITH A CORNEAL ULCER LOCATED BETWEEN 12 AND 1O¿CLOCK; PTS VA OS WAS 20/40 WITH GLASSES, UNSURE IF THIS WAS A SHIFT IN THE VA AS THIS WAS THE FIRST TIME THE PT WAS SEEN BY THE ECP; PT PRESCRIBED ZYMAXID Q1 HOUR OS WHILE AWAKE, BACITRACIN OINTMENT AT BEDTIME UNTIL FOLLOW-UP EXAM ON (B)(6) 2017. PT WAS SEEN FOR FOLLOW-UP VISIT ON (B)(6) 2017, ULCER LOOKING BETTER, FEELING BETTER; ZYMAXID DECREASED TO Q 3H, BACITRACIN OINTMENT AT BEDTIME. ON (B)(6) 2017 THE PT WAS SEEN FOR A FOLLOW-UP VISIT, ULCER LOOKING BETTER, FEELING BETTER; ZYMAXID DECREASED TO TID; BACITRACIN OINTMENT AT BEDTIME. ON (B)(6) 2017 THE PT RETURNED FOR AN ADDITIONAL FOLLOW-UP VISIT AND ADVISED TO CONTINUE MEDS UNTIL (B)(6) 2017, THEN DISCONTINUE AND TO STOP LENS WEAR FOR ANOTHER 2 WEEKS; THE ECP NOTED A SCAR ON THE CORNEA BETWEEN 12 AND 1 O¿CLOCK. NO ADDITIONAL MEDICAL INFORMATION WAS RECEIVED AND NO ADDITIONAL MEDICAL INFORMATION IS EXPECTED. A LOT HISTORY REVIEW WAS PERFORMED AND REVEALED THE FOLLOWING: THE BATCH RECORD DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. LOT B00M0SQ WAS PRODUCED UNDER NORMAL CONDITIONS. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED WITHIN 30 DAYS OF RECEIPT. SERIOUS REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN FRANCHISE MANAGEMENT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311573 ACUVUE OASYS FOR ASTIGMATISM LENSES, SOFT CONTACT, EXTENDED WEAR LPM JOHNSON & JOHNSON VISION CARE, INC. ¿ US NA B00M0SQ

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R