BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE® OASYS®

    MDR report key: 5480768 · Received March 4, 2016

    Report

    Report Number
    1033553-2016-00021
    Event Type
    Injury
    Date Received
    March 4, 2016
    Date of Event
    February 11, 2016
    Report Date
    April 6, 2016
    Manufacturer
    JOHNSON & JOHNSON VISION CARE, INC. ¿ US
    Product Code
    LPM
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL RECORDS RECEIVED FROM THE PATIENT'S (PT) EYE CARE PROVIDER (ECP) ON 06APR2016: DATE OF VISIT: (B)(6) 2016; COMPLAINT: SEE NOTES; SYMPTOMS: BLURRED VISION; HEADACHES ¿ SINCE THIS MORNING; REDNESS; DOUBLE VISION; GLARE/LIGHT/SENSITIVITY; WATERY EYES; HEADACHES: YES; INJURY: NO INFECTION: NONE; OTHER HEALTH: NONE; MEDICATIONS: PARIET; CIPRALEX MEDICAL NOTES: OD RED AND PAINFUL SINCE LAST NIGHT WHEN HE TOOK OUT HIS CONTACTS (AC OASYS). CHANGES BIWEEKLY, 7/WEEK; HAD ISSUES WITH CONTACTS IN (B)(6) 2015, SAW OD IN (B)(6) 2015, VARIABLE SOLUTION (OPTI FREE SOLUTION); NO OVERNIGHT WEAR; WATERY, MATTED SHUT, PHOTOPHOBIA; GETTING WORSE THROUGHOUT THE DAY/NEW CONTACTS BEEN PROBLEMATIC SINCE GETTING THEM. LAST EYE EXAM: 2015; ASSESSMENT AND PLAN: CL INDUCED KERATITIS, RX TOBRADEX OPH SOLUTION, 1 DROP QID ONLY; DISPENSE 5 ML DATE OF VISIT: (B)(6) 2016; COMPLAINT: KERATITIS/ULCER OD; VISION WORST IN OD; SYMPTOMS: BLURRED VISION ¿ LESS THAN BEFORE; REDNESS; DOUBLE VISION ¿ NOT AS BAD; GLARE/LIGHT SENSITIVITY ¿ DECREASED; WATERY EYES - DECREASED. HEADACHES: YES; INFECTION: NONE; OCULAR HISTORY: STEROID RESPONDER; MEDICATIONS: PARIET; CIPRALEX; TOBRADEX BID OD ONLY; MEDICAL NOTES: OD RED AND PAINFUL SINCE LAST NIGHT WHEN HE TOOK OUT HIS CONTACTS (AC OASYS). CHANGES BIWEEKLY, 7/WEEK; HAD ISSUES WITH CONTACTS IN (B)(6) 2015, SAW OD IN(B)(6) 2015, VARIABLE SOLUTION (OPTI FREE SOLUTION); NO OVERNIGHT WEAR; WATERY, MATTED SHUT, PHOTOPHOBIA; GETTING WORSE THROUGHOUT THE DAY/NEW CONTACTS BEEN PROBLEMATIC SINCE GETTING THEM; EXAM: OD: X 2 SCAR; TONOMETRY: GOLDMAN USING FLURESS AT 5:19 PM - OD: 26 MMHG; ASSESSMENT AND PLAN: RESOLVED KERATITIS OD ¿ STEROID RESPONDER! D/C TOBRADEX. RTC 1 WEEK FOR FULL EXAM AND POTENTIAL CL FITTING. ON (B)(6) 2016 A CALL WAS PLACED TO THE PATIENTS (PT) EYE CARE PROVIDER (ECP) AND ADDITIONAL MEDICAL INFORMATION WAS OBTAINED AS FOLLOWS: THE PT RETURNED FOR EYE EXAM AND CONTACT LENS REFITTING ON (B)(6) 2016. THE PT WAS REFIT IN ACUVUE 1-DAY MOIST MULTIFOCAL "TO REDUCE THE RISK OF FURTHER EPISODES OF KERATITIS." THE ECP REPORTED THAT THE "PT OVERWORE THE OASYS LENSES WHICH IS WHY HE'S IN THE PREDICAMENT HE'S IN NOW." THE ECP ALSO REPORTED THAT "THE PT WAS NOT FIT IN THE OASYS LENSES." THE PT IS REPORTED TO BE DOING WELL IN THE 1-DAY MOIST MULTIFOCAL LENSES WITHOUT FURTHER COMPLAINT NOTED. (B)(4). THE CORRECT LOT # PROVIDED BY THE PT FOR THE OD IS B00K33Z. THE SUSPECT PRODUCT WAS DISCARDED BY THE PATIENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2016 A PATIENT (PT) CALLED TO REPORT DISCOMFORT WITH HIS/HER REPLACEMENT BOX OF ACUVUE OASYS LENSES. ON (B)(6) 2016 A CALL WAS PLACED TO THE PT WHO REPORTED THAT HE/SHE WAS EXPERIENCING RED EYES AND IRRITATION OU WHILE WEARING THE ACUVUE OASYS REPLACEMENT LENSES THAT WERE SENT TO HIM FOR A PREVIOUS ISSUE HE/SHE REPORTED IN (B)(6) 2015 FOR REDNESS AND IRRITATION. THE PT REPORTED THAT HE/SHE WAS GOING TO HIS/HER FAMILY DOCTOR TODAY FOR A REFERRAL TO AN OPHTHALMOLOGIST. THE PT REPORTED THAT HE/SHE "CANNOT WEAR THE LENSES AT ALL AND HIS/HER EYES ARE "BEET RED" AND "KILLING ME." THE PT REPORTED THAT HE/SHE IS NOT CURRENTLY WEARING CONTACT LENSES, BUT IS EXPERIENCING PAIN, IRRITATION, AND EYES ARE RED. ON (B)(6) 2016 THE PT PROVIDED ADDITIONAL MEDICAL INFORMATION AS FOLLOWS: THE PT REPORTED THAT HE/SHE WENT TO SEE AN EYE CARE PROVIDER (ECP) ON (B)(6) 2016 AND WAS DIAGNOSED WITH KERATITIS OD AND A CATARACT IN THE OS. THE PT REPORTED THAT THE ECP STATED THAT HE/SHE "THAT THE OD HAD OLD SCARRING AND NEW SCARRING." THE PT REPORTED THAT HE/SHE WAS TOLD BY THE ECP THAT HE/SHE HAD "SCARRING ON THE EDGE OF THE CORNEA HAD GOTTEN BIGGER THE PT WOULD HAVE A LOSS OF VISION." THE PT REPORTED THAT HE/SHE THINKS THAT THE PREVIOUS LOT NUMBER REPORTED AS B00K509 IS RELATED TO THE "OLD SCARRING" EVENT. THE PT REPORTED THAT HE/SHE DID NOT SEE AN ECP FOR THAT EVENT. THE PT REPORTED THAT HE/SHE WAS GIVEN TOBRADEX OPHTHALMIC DROPS 1 DROP OD QID FOR 5 DAYS. THE PT ALSO REPORTED THAT HE/SHE HAS A FOLLOW-UP APPOINTMENT WITH THE ECP ON (B)(6) 2016. THE PT REPORTED THAT HE/SHE "FELT A LITTLE BETTER TODAY." THE PT REPORTED THAT THE ECP TOLD THE PT THAT IT WOULD BE "A WHILE" BEFORE HE/SHE CAN USE CONTACT LENSES AGAIN AND AT THAT TIME HE/SHE WOULD BE GIVEN A DAILY CONTACT LENS. THE PT DID NOT HAVE THE LOT NUMBER FOR THE CURRENT BOX OF LENSES OD AND REPORTED THAT HE/SHE WOULD SEND THE LOT NUMBER VIA E-MAIL. TWO CALLS WERE PLACED TO THE PT'S TREATING ECP FOR ADDITIONAL INFORMATION, BUT NOTHING ADDITIONAL HAS BEEN RECEIVED. THE LOT NUMBER OF THE PT'S CURRENT OASYS BOX IS UNKNOWN. THE PREVIOUSLY REPORTED LOT NUMBER WAS B00K509, BUT THE SUSPECT PRODUCT WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN FOR EVALUATION. THE CURRENT LOT NUMBER WAS REQUESTED FROM THE PT, BUT HAS NOT YET BEEN RECEIVED. ON (B)(6) 2016 AN E-MAIL WAS RECEIVED FROM THE PT WHO REPORTED THAT HE/SHE SENT THE CURRENT SUSPECT PRODUCT FOR RETURN FOR EVALUATION. THE LOT NUMBER WAS NOT PROVIDED. THE PT ALSO REPORTED THAT HE/SHE WAS "EN ROUTE TO SEE MY EYE DOCTOR AGAIN. THIS WILL BE THE FOURTH VISIT." THE PT REPORTED THAT HE/SHE HAD WAS ADVISED BY THE ECP TO DISCONTINUE THE PRESCRIBED EYE DROPS. THE PT ALSO REPORTS THAT HE/SHE IS STILL EXPERIENCING "FUZZY VISION." THE PT REPORTED THAT HE/SHE "SHOULD GET A PROGNOSIS AND RECOMMENDED NEXT STEPS TODAY." NO ADDITIONAL MEDICAL INFORMATION WAS OBTAINED. 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 B00K509 WAS PRODUCED UNDER NORMAL CONDITIONS. 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
    136370 ACUVUE® OASYS® LENSES, SOFT CONTACT, EXTENDED WEAR LPM JOHNSON & JOHNSON VISION CARE, INC. ¿ US B00K33Z

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other| R