BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS

    MDR report key: 8578527 · Received May 3, 2019

    Report

    Report Number
    9617710-2019-00010
    Event Type
    Injury
    Date Received
    May 3, 2019
    Date of Event
    April 7, 2019
    Report Date
    April 12, 2019
    Manufacturer
    JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND
    Product Code
    LPM
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).

    Description of Event or Problem · 1

    ON 12APR2019 AN EYE CARE PROVIDER (ECP) IN (B)(6) CALLED TO REPORT A PATIENT (PT) WAS DIAGNOSED WITH A SEVERE CORNEAL ULCER OS AND HOSPITALIZED WHILE WEARING AN ACUVUE OASYS BRAND CONTACT LENS. ON (B)(6) 2019 AFTER APPROXIMATELY 5 HOURS OF CONTACT LENS (CLS) WEAR THE PT FELT A LIGHT DISCOMFORT OS. THE PT WOKE THE FOLLOWING AM AND REPORTED THE OS WAS SWOLLEN AND ¿STICKY¿. IT IS UNKNOWN IF THE SUSPECT CLS WAS WORN DURING THE NIGHT. THE PT SOUGHT MEDICAL ATTENTION AND WAS HOSPITALIZED UNTIL (B)(6) 2019. THE PT WAS PRESCRIBED PGV ATROPIC I 1% ONCE A DAY FOR APPROXIMATELY ONE WEEK AND IF NECESSARY, VISMED AS A SUPPLEMENT. THE PT HAS A FOLLOW-UP APPOINTMENT ON TUESDAY, (B)(6) 2019 WITH THE OPHTHALMOLOGIST. NO ADDITIONAL MEDICAL INFORMATION WAS PROVIDED. ON (B)(6) 2019 A CALL WAS PLACED TO THE PTS TREATING ECP FOR ADDITIONAL MEDICAL INFORMATION. NO ADDITIONAL INFORMATION WAS PROVIDED AS THE ECP IS OUT OF THE OFFICE UNTIL (B)(6) 2019. THE SUSPECT OS LENS WAS DISCARDED. 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 L003427 WAS PRODUCED UNDER NORMAL CONDITIONS. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370250 ACUVUE OASYS LENSES, SOFT CONTACT, EXTENDED WEAR LPM JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND NA L003427

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R