BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1-DAY ACUVUE DEFINE WITH LACREON

    MDR report key: 7422901 · Received April 11, 2018

    Report

    Report Number
    9617710-2018-05029
    Event Type
    Injury
    Date Received
    April 11, 2018
    Report Date
    March 16, 2018
    Manufacturer
    JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND
    Product Code
    LPL
    PMA / PMN Number
    N18033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORTER¿S PHONE NUMBER: (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2018 AN EMAIL WAS RECEIVED FROM A PATIENT (PT) IN (B)(6) REPORTING EXCESSIVE MOVEMENT, UNEVEN COLOR PRINT AND EXPERIENCED IRRITATION AFTER INSERTION OF THE 1-DAY ACUVUE® DEFINE¿ WITH LACREON® BRAND CONTACT LENSES. THE PT IS AN EXPERIENCED WEARER. THE PT REPORTED THE EVENT DATE AS (B)(6) 2018. ON (B)6) 2018 THE PT REPORTED THE EYE CARE PROVIDER (ECP) HAS NOT DIAGNOSED THE PT WITH UVEITIS, BUT THE PT FEELS THE ¿SYMPTOMS ARE SIMILAR¿ TO A PREVIOUS EVENT. ON (B)(6) 2018 THE PT WENT TO THE EMERGENCY ROOM VISIT (B)(6) 2018. PT REPORTED A DIAGNOSIS OF UVEITIS IN THE OD. THE PT WAS PRESCRIBED STEROID EYE DROPS EVERY HOUR FOR THREE HOURS, THEN REDUCE TO ONCE EVERY TWO HOURS. THE PT HAS A FOLLOW-UP APPOINTMENT WITH THE ECP ON (B)(6) 2018. THE PT WILL SEND THE MEDICAL DOCUMENTS. ON (B)(6) 2018 AN EMAIL WAS RECEIVED FROM THE PT WITH PHARMACY RECEIPT, PRESCRIPTION, AND FOLLOW-UP APPOINTMENT LETTER. PT REPORTED THE SYMPTOMS WORSENED ON (B)(6) 2018 AND THE PT WENT TO THE HOSPITAL. PRESCRIPTION DATED (B)(6) 2018 FOR PRED FORTE RE QID FOR 1 MONTH; CYCLOPENTOLATE 1% RE TDS FOR 1 MONTH; MAXIDEX RE NOCTE FOR 2 OP. A FOLLOW-UP APPOINTMENT LETTER FOR (B)(6) 2018 WITH ECP @ 1:00PM. ON (B)(6) 2018 AN EMAIL WAS RECEIVED FROM THE PT WHO REPORTED HE/SHE CONTACTED THE TREATING ECP, BUT THE ECP HAS NOT RESPONDED. ON (B)(6) 2018 AN EMAIL WAS RECEIVED FROM THE PATIENT (PT) WHO PROVIDED A HOSPITAL MEDICAL RECORD DATED (B)(6) 2018: PT WAS REFERRED TO THE HOSPITAL DUE TO POSSIBLE UVEITIS OU; PT WAS DIAGNOSED WITH RECURRENCE OF RIGHT ANTERIOR/IMMEDIATE UVEITIS; NO MEDICATIONS WERE PRESCRIBED; PT COMPLAINED OF 1 WEEK OF FLOATERS AND BLURRED VISION AND A FEW WEEKS OF DISCOMFORT; EXAM NOTED AC +1 CELLS AND VIRITIS +2 CELLS; PLAN INCLUDED G PF Q 1 HOUR FOR 3 DAYS, G CYCLO TDS, RETURN TO CLINIC NEXT WEEK; ¿VA MEASURED 6/8.6 OD¿. ON (B)(6) 2018 A CALL WAS PLACED TO THE PATIENT (PT) AND ADDITIONAL INFORMATION WAS PROVIDED: PT MISSED DOCTOR¿S APPOINTMENTS DUE TO (B)(6) HOLIDAYS, BUT PLANS TO MAKE ANOTHER VISIT SOON. PT REPORTED THAT THE SYMPTOMS ARE SUBSIDING. ON (B)(6) 2018 ADDITIONAL INFORMATION WAS RECEIVED FROM THE PT: PT REPORTED THAT THE LENSES WERE RETURNED FOR EVALUATION. PT REPORTED THAT HER EYE CONDITION HAS BEEN GETTING BETTER WITH ¿IRRITATIONS SETTLING DOWN¿. PT REPORTED THE UVEITIS CONDITION HAS ¿SETTLED DOWN¿ AND PT DOESN¿T PLAN TO FURTHER VISIT HER DOCTOR ON THAT MATTER. 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 3425230458 WAS PRODUCED UNDER NORMAL CONDITIONS. NO ADDITIONAL MEDICAL INFORMATION HAS BEEN RECEIVED. NO ADDITIONAL INFORMATION IS EXPECTED. 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
    264795 1-DAY ACUVUE DEFINE WITH LACREON LENSES, SOFT CONTACT, DAILY WEAR LPL JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND NA 3425230458

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R