BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS

    MDR report key: 7328416 · Received March 9, 2018

    Report

    Report Number
    9617710-2018-05025
    Event Type
    Injury
    Date Received
    March 9, 2018
    Report Date
    March 9, 2018
    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

    TWO OPENED BLISTERS WERE RECEIVED CONTAINING 2 LENSES. THE PARAMETERS OF THE TWO LENSES WERE MEASURED AND A VISUAL INSPECTION WAS PERFORMED. THE LENSES MEET COMPANY STANDARDS FOR BASE CURVE, CENTER THICKNESS, AND DIAMETER. ONE LENS WAS OBSERVED TO HAVE EDGE TEARS AND DEPOSITS. ONE LENS WAS OBSERVED TO HAVE EDGE TEARS, EXCESS POLYMER AND DEPOSITS. THE IDENTIFICATION OF DEPOSITS IS INCONCLUSIVE DUE TO THE LENSES BEING RETURNED IN AN OPEN PACKAGE; IT IS NOT KNOWN WHAT OUTSIDE INFLUENCES MIGHT HAVE IMPACTED THE LENSES. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCLUSION NOT YET AVAILABLE-EVALUATION IS PROGRESS.

    Description of Event or Problem · 1

    ON (B)(6) 2018 A PATIENT (PT) IN (B)(6) REPORTED IRRITATION WHILE WEARING THE ACUVUE OASYS BRAND CONTACT LENSES. ON (B)(6) 2018 THE PT CALLED AND ADDITIONAL INFORMATION WAS PROVIDED: PT REPORTED DISCOMFORT AND IRRITATION WHILE WEARING THE OASYS CONTACT LENSES. PT REPORTED AFTER THE SUSPECT LENS WERE REMOVED THE EYE WAS RED, IRRITATED AND TEARING. PT REPORTED THE EVENT BEGAN IN (B)(6) 2017. PT REPORTED HE/SHE HAS NOT RETURNED TO CONTACT LENS WEAR AND IS CURRENTLY WEARING GLASSES. THE PT DID NOT SEEK MEDICAL ATTENTION. PT REPORTED USING SALINE SOLUTION TO CLEAN THE EYES. PT USED RENU SOLUTION TO CLEANSE AND DISINFECT THE LENSES. PT HAS A REPLACEMENT SCHEDULE OF 30-45 DAYS AND A DAILY WEAR SCHEDULE. ON (B)(6) 2018 AN EMAIL WAS RECEIVED FROM THE PT AND ADDITIONAL INFORMATION WAS PROVIDED: AN EYE CARE PROFESSIONAL¿S (ECP) NOTE WAS RECEIVED DATED (B)(6) 2018 REPORTED A DIAGNOSIS OF OS KERATITIS. PRESCRIPTION DATED (B)(6) 2018 FOR VIGADEXA OPHTHALMIC SOLUTION 1 DROP OS Q 3 HOURS; CEPHALEXIN 1GR PO Q 12 HOURS FOR 7 DAYS; DECADRON 0.75 PO Q 12 HOURS. ON (B)(6) 2018 A CALL WAS PLACED TO THE PT AND ADDITIONAL INFORMATION WAS PROVIDED: PT REPORTED THE ECP ADVISED THE PT TO USE ALL 3 MEDICATIONS FOR 7 DAYS AND RETURN FOR A FOLLOW-UP VISIT ON (B)(6) 2018. PT REPORTED THE OS WAS BETTER AND THE REDNESS HAS RESOLVED. PT REPORTED THE ECP ADVISED THE PT TO SUSPEND CONTACT LENS USE WHILE USING THE MEDICATION. NO ADDITIONAL MEDICAL INFORMATION WAS PROVIDED. ON (B)(6) 2018 AN EMAIL WAS RECEIVED FROM THE PT WITH ADDITIONAL INFORMATION: THE PT WENT TO THE ECP FOR FOLLOW-UP VISIT ON (B)(6) 2018 AND WILL HAVE ¿OTHER MEDICAL TESTS¿. PT WILL SEND THE MEDICAL DOCUMENTS. ON (B)(6) 2018 AN EMAIL WAS RECEIVED FROM THE PT WITH THREE ATTACHMENTS: ATTACHMENT: DATED 21FEB2018, REFRACTION: OD -4.25, OS -4.75; ATTACHMENT: ECP NOTE: ¿TO WHOM IT MAY CONCERN: I ATTEST (B)(6) WAS UNDER OUR CARE ON (B)(6) 2018;¿ ATTACHMENT: ORDER FOR OU EXAMS; CORNEAL SPECULAR MICROSCOPY, PAM-VISUAL ACUITY LASER, ULTRASOUND PACHYMETRY, COMPUTERIZED TOPOGRAPHY, ULTRASOUND. A CALL WAS PLACED TO THE PT ON 22FEB2018 AND PT REPORTED THE EYE WAS OK AT THE VISIT AND THE MEDICATIONS WERE DISCONTINUED. PT HAS NOT BEEN CLEARED FOR CONTACT LENS WEAR AND STILL NEEDS OTHER EXAMS, BUT THE PT HASN¿T SCHEDULED THE EXAMS. PT DOES NOT PLAN TO RETURN TO CONTACT LENS WEAR. THE SUSPECT PRODUCT HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. 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 L002WS9 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
    170991 ACUVUE OASYS LENSES, SOFT CONTACT, EXTENDED WEAR LPM JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND NA L002WS9

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R