BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS1 DAY WITH HYDRALUXE TECHNOLOGY

    MDR report key: 7253007 · Received February 8, 2018

    Report

    Report Number
    9617710-2018-05013
    Event Type
    Injury
    Date Received
    February 8, 2018
    Report Date
    January 15, 2018
    Manufacturer
    JOHNSON & JOHNSON VISION CARE, INC. ¿ LIMERICK
    Product Code
    LPL
    PMA / PMN Number
    K042275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2018 A PATIENT (PT) IN (B)(6) REPORTED DISCOMFORT (AFFECTED EYE NOT PROVIDED) IN (B)(6) 2017 WHILE WEARING THE ACUVUE OASYS 1 DAY BRAND CONTACT LENS. THE PT REPORTED WEARING THE SUSPECT LENS 30 TO 60 MINUTES. THE SUSPECT LENS WAS REMOVED AND THE PT NOTICED THE LENS WAS TORN. THE PT REPORTED THE REDNESS SEEMED TO RESOLVE THE NEXT DAY. THE PT WORE GLASSES. THE PT DEVELOPED EYE SWELLING A FEW DAYS AFTER THE EVENT. ON (B)(6) 2018 THE PT WENT TO AN EYE CARE PROVIDER (ECP) AND WAS DIAGNOSED WITH ¿BACTERIA IN THE EYE AND STAINING¿. THE PT WAS PRESCRIBED EYE DROPS, BUT REFUSED TO PROVIDE THE NAME OR FREQUENCY OF THE TREATMENT. THE PT REPORTED THE EYE SWELLING IS PERSISTING. THE PT REFUSED TO PROVIDE ANY ADDITIONAL MEDICAL INFORMATION AND REFUSED THE MEDICAL INTERVIEW. NO ADDITIONAL MEDICAL INFORMATION WAS PROVIDED AND NO ADDITIONAL INFORMATION IS EXPECTED. 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 5523900106 WAS PRODUCED UNDER NORMAL CONDITIONS. THE SUSPECT PRODUCT WAS DISCARDED. 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
    100679 ACUVUE OASYS1 DAY WITH HYDRALUXE TECHNOLOGY LENSES, SOFT CONTACT LPL JOHNSON & JOHNSON VISION CARE, INC. ¿ LIMERICK NA 5523900106

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R