BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS

    MDR report key: 9234850 · Received October 24, 2019

    Report

    Report Number
    9617710-2019-00039
    Event Type
    Injury
    Date Received
    October 24, 2019
    Date of Event
    October 5, 2019
    Report Date
    February 20, 2020
    Manufacturer
    JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND
    Product Code
    LPM
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE LENS CASE WAS RECEIVED CONTAINING 2 OPENED LENSES FOR LOT # L003QHP. THE PARAMETERS OF THE LENSES WERE MEASURED, AND A VISUAL INSPECTION WAS PERFORMED. NO VISUAL ATTRIBUTES WERE OBSERVED ON THE 2 OPENED LENSES. THE LENSES MEET COMPANY STANDARDS FOR POWER, BASE CURVE, CENTER THICKNESS, AND DIAMETER. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED. SECTION H - 6: CODE 10 - TESTING OF ACTUAL/SUSPECTED DEVICE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2019 A PATIENT (PT) IN (B)(6) CALLED TO REPORT REDNESS, PAIN, AND SWELLING WHILE WEARING 1 OD ACUVUE® OASYS® BRAND CONTACT LENS (CL) ON (B)(6) 2019. THE PT DID NOT NOTICE ANYTHING UNUSUAL WITH THE LENS ON REMOVAL. THE PT WENT TO THE EYE CARE PROVIDER (ECP) ON (B)(6) 2019 AND DIAGNOSED AN ¿INFECTION AND LESION ON OD CAUSED BY BACTERIA.¿ THE PT WAS PRESCRIBED VIGAMOX 1 DROP Q4H UNTIL (B)(6) 2019 FOLLOW-UP APPOINTMENT. THE PT REPORTS DAILY LENS WEAR WITH A MONTHLY REPLACEMENT SCHEDULE. THE PT USES ULTRASEPTI TO CLEAN THE LENSES. ON (B)(6) 2019 A CALL WAS PLACED TO THE PT AND ADDITIONAL INFORMATION WAS PROVIDED: THE PT REPORTED THE OD IS MUCH BETTER AFTER STARTING THE MEDICATION. ON (B)(6) 2019 AN EMAIL WAS RECEIVED FROM THE PT WITH MEDICAL REPORT: THE ECP NOTE IS DATED 09OCT2019; THE PT WAS DIAGNOSED WITH INFECTIOUS KERATITIS OD AND WAS PRESCRIBED VIGADEXA ANTIBIOTIC EYE DROPS 1 DROP Q4H AND HAS IMPROVEMENT OF THE INJURY. ON (B)(6) 2019 A CALL WAS PLACED TO THE PT AND ADDITIONAL INFORMATION WAS PROVIDED: FOLLOW-UP VISIT ON (B)(6) 2019, PT WAS ADVISED TO CONTINUE THE VIGADEXA Q4H UNTIL (B)(6) 2019 ON THE FOLLOW-UP VISIT. THE ECP ADVISED THE PT NOT TO RETURN TO CLS WEAR FOR 15 DAYS. THE PT ADVISED THE OD IS OK NOW. NO ADDITIONAL MEDICAL INFORMATION WAS PROVIDED. ON (B)(6) 2019 AND EMAIL WAS RECEIVED FROM THE PT WITH A NOTE FROM THE TREATING ECP: THE ECP NOTE DATED (B)(6) 2019 ADVISED THE PT'S CLS WEAR IS DISCONTINUED INDEFINITELY DUE TO COMPLICATIONS DEVELOPED FROM CONTACT LENS WEAR. THE PT IS TO ONLY WEAR GLASSES. THE SUSPECT OD LENS WAS REQUESTED FOR RETURN FOR EVALUATION, BUT IT HAS NOT BEEN RECEIVED. 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 L003QHP 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
    1028004 ACUVUE OASYS LENSES, SOFT CONTACT, EXTENDED WEAR LPM JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND NA L003QHP

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other| R ULTRASEPTI