BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE 2 DEFINE

    MDR report key: 7958288 · Received October 11, 2018

    Report

    Report Number
    9617710-2018-05056
    Event Type
    Injury
    Date Received
    October 11, 2018
    Date of Event
    September 4, 2018
    Report Date
    November 16, 2018
    Manufacturer
    JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND
    Product Code
    LPM
    PMA / PMN Number
    N18033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON 16NOV2018 ADDITIONAL MEDICAL INFORMATION WAS RECEIVED FROM THE JAPAN AFFILIATE. THE PATIENT (PT) WAS SEEN BY THE EYE CARE PROVIDER (ECP) ON (B)(6) 2018 AND DIAGNOSED WITH CORNEAL ULCER AND CONJUNCTIVITIS. THE PT PRESENTED WITH PAIN, REDNESS AND TEARING; A DRAWING DEPICTS THE LOCATION OF THE CORNEAL ULCER AT 1 O¿CLOCK, OFF PUPIL; THE VA WAS NOT INDICATED. THE PT WAS PRESCRIBED OFLOGEL EYE DROPS, TOBRACIN EYE DROPS 8 TIMES DAILY AND ECOLICIN OPHTHALMIC OINTMENT FOR OD QID. 10SEP2018 THE PT RETURNED TO THE ECP FOR A FOLLOW-UP VISIT. THE CORNEAL ULCER WAS RESOLVING, BUT REMAINS; VA OD 1.2; PT WAS PRESCRIBED OFLOGEL EYE DROPS AND TOBRACIN EYE DROPS QID. 18SEP2018 FOLLOW-UP VISIT: OUTCOME: IMPROVED, OPACITY REMAINING; PT WAS INSTRUCTED TO RETURN TO THE CLINIC IN 1 MONTH. 10OCT2018 FOLLOW-UP VISIT: NO PAIN WHEN USING THE CONTACT LENSES. NO ADDITIONAL MEDICAL INFORMATION HAS BEEN RECEIVED. NO ADDITIONAL MEDICAL INFORMATION IS EXPECTED. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED. SECTION H ¿ 6: CODE 1784 ¿ CONJUNCTIVITIS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2018 A REPRESENTATIVE FROM AN EYE CARE PROVIDER¿S OFFICE (ECP) IN (B)(6) CALLED TO REPORT A PATIENT (PT) HAD COMPLAINTS OF REDNESS, PAIN, TEARING AND DISCHARGE OD ON (B)(6) 2018 WHILE WEARING THE ACUVUE2 DEFINE BRAND CONTACT LENSES. ON (B)(6) 2018, THE PT WENT TO THE ECP AND WAS DIAGNOSED WITH A CORNEAL ULCER OD. THE PT RETURNED TO THE ECP ON (B)(6) 2018. THE PT WAS PRESCRIBED OFLOGEL EYE DROPS, TOBRACIN (TOBRAMYCIN) EYE DROPS AND ECOLICIN OPHTHALMIC OINTMENT (ERYTHROMYCON LACTOBIONATE). THE REPRESENTATIVE REPORTED THE REDNESS AND PAIN HAD CURRENTLY RESOLVED. THE PT WAS ADVISED TO RETURN TO THE ECP IN 2-3 WEEKS. A MEDICAL INTERVIEW WITH THE ECP WAS SCHEDULED FOR (B)(6) 2018. ON 27SEP2018 A CALL WAS PLACED TO THE ECP¿S OFFICE TO CONFIRM THE MEDICAL INTERVIEW ON (B)(6) 2018. IT WAS CONFIRMED THE ECP WILL BE UNAVAILABLE AND THE MEDICAL INTERVIEW WAS RESCHEDULED FOR (B)(6) 2018. ON (B)(6) 2018 THE ECP WAS UNAVAILABLE FOR THE MEDICAL INTERVIEW. THE ECP IS TO SEND ADDITIONAL MEDICAL INFORMATION VIA MAIL. NO ADDITIONAL MEDICAL INFORMATION HAS BEEN RECEIVED. THE SUSPECT OD 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 3627020101 WAS PRODUCED UNDER NORMAL CONDITIONS. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED. SERIOUS REPORTABLE EVENT TRENDS ARE REVIEWED QUARTERLY IN FRANCHISE MANAGEMENT REVIEW MEETINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799483 ACUVUE 2 DEFINE LENSES, SOFT CONTACT, EXTENDED WEAR LPM JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND NA 3627020101

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R