BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS

    MDR report key: 8676635 · Received June 6, 2019

    Report

    Report Number
    1057985-2019-00050
    Event Type
    Injury
    Date Received
    June 6, 2019
    Date of Event
    April 30, 2019
    Report Date
    May 14, 2019
    Manufacturer
    JOHNSON & JOHNSON VISION CARE, INC. ¿ US
    Product Code
    LPM
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2019, A REPRESENTATIVE FROM AN EYE CARE PROVIDER'S (ECP) OFFICE CALLED TO REPORT A PATIENT (PT) WAS DIAGNOSED WITH A CORNEAL ULCER WHILE WEARING AN ACUVUE® OASYS® BRAND CONTACT LENS (CL). THE PT WORE 2 CLS ON THE LEFT EYE (OS) AND PRESENTED TO THE ECP WITH REDNESS AND IRRITATION. THE PT WAS REFERRED TO AND SEEN BY A DIFFERENT ECP ON (B)(6) 2019 AND WAS DIAGNOSED WITH A MARGINAL CORNEAL ULCER OS. THE PT WAS PRESCRIBED BESIVANCE, 1 DROP EVERY 2 HOURS FOR THE FIRST DAY THEN FOUR TIMES A DAY (DURATION UNKNOWN). ON (B)(6) 2019, ADDITIONAL INFORMATION WAS RECEIVED FROM A REPRESENTATIVE OF THE TREATING ECP: THE PT WAS SEEN FOR A FOLLOW-UP VISIT ON (B)(6) 2019 AND WAS TOLD THE ULCER HAD RESOLVED AND PT CAN RESUME CL WEAR. ON (B)(6) 2019, THE PT¿S MEDICAL RECORDS WERE RECEIVED FROM THE TREATING ECP: DATE OF VISIT: (B)(6) 2019. IMPRESSION: MARGINAL CORNEAL ULCER, LEFT EYE. PLAN: DISCUSSED DIAGNOSIS IN DETAIL WITH PT. INFECTED ULCER. START BESIVANCE TODAY Q2H, TOMORROW QID UNTIL NEXT VISIT. CHIEF COMPLAINT: PT PRESENTS WITH OS REDNESS THAT STARTED YESTERDAY, PAIN '8' ON SCALE OF 1-10, SENSITIVE TO LIGHT. OCULAR HISTORY: CAT EXTRACTION W POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL) ¿ OS ¿ (B)(6) 2018. VISUAL ACUITY: CURRENT VISIT - SNELLEN. OS: 20/40 -2. SLIT LAMP EXAM: CONJUNCTIVA: OS 3+ INJECTED. CORNEA: OS MARGINAL ULCER @ 2:00. LENS: OS PCIOL IN PLACE. MEDICATIONS PRESCRIBED TODAY: CLARITIN-D 12HR 5MG-120MG TABLE, EXTENDED RELEASE TAKE 1 TABLET PO Q12H. BESIVANCE 0.6 % EYE DROPS, SUSPENSION INSTILL 1 DROP OS Q2H TODAY, TOMORROW START QID. FOLLOW-UP VISIT: (B)(6) 2019. IMPRESSION: MARGINAL ULCER, OS. PLAN: RESOLVED, HOWEVER NO CL, USE BESIVANCE OS UNTIL SUNDAY, SHOULD BE HEALED BY MON AM, THEN PT CAN CONTINUE CL. PT TO CONSIDER DIFFERENT OPTIONS FOR CL, RECOMMEND DAILIES. HISTORY OF PRESENT ILLNESS: PT PRESENTS FOR EVALUATION OF OS K ULCER. PT STATES HER OS FEELS BETTER SINCE LAST APPT AND HAS BEEN COMPLIANT WITH BESIVANCE TO OS QID. VISUAL ACUITY: CURRENT VISIT ¿ SNELLEN. OS: 20/40 -1. SLIT LAMP EXAMINATION: CONJUNCTIVA: WHITE AND QUIET. CORNEA: OS SPK, K ULCER RESOLVED. LENS: OS PCIOL IN PLACE. FOLLOW UP: PRN MARGINAL CORNEAL ULCER, LEFT EYE. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. THE SUSPECT OS CL 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 B00RLPH 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
    468208 ACUVUE OASYS LENSES, SOFT CONTACT, EXTENDED WEAR LPM JOHNSON & JOHNSON VISION CARE, INC. ¿ US NA B00RLPH

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other| R