BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS FOR ASTIGMATISM

    MDR report key: 7321448 · Received March 7, 2018

    Report

    Report Number
    1057985-2018-00026
    Event Type
    Injury
    Date Received
    March 7, 2018
    Report Date
    February 6, 2018
    Manufacturer
    JOHNSON & JOHNSON VISION CARE, INC. ¿ US
    Product Code
    LPM
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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) FROM (B)(6)TO REPORT OD DISCOMFORT IMMEDIATELY UPON INSERTING THE SUSPECT ACUVUE OASYS FOR ASTIGMATISM BRAND CONTACT LENS IN (B)(6) 2018. PT REPORTED EYE PAIN AND HEADACHE ON REMOVAL OF THE SUSPECT LENS. PT IS A FIRST-TIME WEARER OF THE OASYS FOR ASTIGMATISM BRAND CONTACT LENSES. PT REPORTED A BI-WEEKLY REPLACEMENT SCHEDULE AND DOES NOT SLEEP IN THE LENSES. PT WENT TO AN EYE CARE PROVIDER (ECP) AND REPORTED THE ECP ADVISED THE ¿OD IS INJURED¿. PT WAS PRESCRIBED CYCLOCORT 1 DROP EVERY 3 HOURS AND CONTACT LENS WEAR WAS SUSPENDED. PT HAS A FOLLOW-UP APPOINTMENT ON (B)(6) 2018. ON 06FEB2018 A CALL WAS PLACED TO THE PT AND ADDITIONAL INFORMATION WAS PROVIDED: PT REPORTED THE ECP VISIT WAS ON (B)(6) 2018. PT WAS NOT GIVEN A DIAGNOSIS AND WAS TOLD THAT THE ¿OD IS HURT A LITTLE BIT¿. PT REPORTED OD PAIN AND BLURRY VISION. PT IS USING THE MEDICATION AND REPORTS THE OD IS BETTER TODAY. PT HAS A FOLLOW-UP APPOINTMENT ON (B)(6) 2018. ON 06FEB2018 A CALL WAS PLACED TO THE PTS TREATING ECP AND ADDITIONAL INFORMATION WAS PROVIDED: ECP REPORTED THE DIAGNOSIS IS OD INFECTIOUS CONJUNCTIVITIS AND IT IS NOT RELATED TO THE PRODUCT. ECP REPORTED TREATMENT OF CYCLOCORT DROPS EVERY 3 HOURS, ¿STANDARD OF TREATMENT¿. CONTACT LENS USE WAS SUSPENDED UNTIL THE RETURN VISIT. ON 07FEB2018 AN EMAIL WAS RECEIVED FROM THE JOHNSON AND JOHNSON PROFESSIONAL AFFAIRS PHYSICIAN: "CONSIDERING THE USE OF CORTICOSTEROIDS I CAN PRESUME THERE WAS NO SERIOUS CORNEAL INJURY ". ON (B)(6) 2018 A CALL WAS PLACED TO THE PTS ECP AND ADDITIONAL INFORMATION WAS REQUESTED. NO ADDITIONAL INFORMATION WAS RECEIVED. ON (B)(6) 2018 THE PT REPORTED HE/SHE WENT TO THE ECP TODAY AND THE ¿EYES ARE HEALTHY¿ AND THE PT CAN CONTINUE CONTACT LENS WEAR. PT REPORTED THE ECP DID NOT PROVIDE A NOTE FOR THE PT. ON 09FEB2018 THE PT CALLED TO REPORT DURING THE ECP VISIT THE PT WAS ADVISED THE ¿OD IS NORMAL¿ PT DID NOT GIVE A DIAGNOSIS. PT SAID THE ECP REPORTED IT ¿COULD HAVE BEEN A CONJUNCTIVITIS OR AN INFECTION¿ AND CLEARED THE PT TO RETURN TO CONTACT LENS WEAR. PT REPORTS HE/SHE STILL FEELS AN ABNORMAL SENSATION OD AND THE PT IS WEARING GLASSES. PT IS ON VACATION AND WILL FOLLOW-UP WITH ECP ON ARRIVAL BACK HOME. ON 12FEB2018 AN EMAIL WAS SENT TO THE PTS TREATING ECP REQUESTING PT DIAGNOSIS AND TREATMENT. ON 20FEB2018 AN EMAIL WAS RECEIVED FROM THE PTS TREATING ECP: THE ECP REPORTED THE PT ¿CAME IN FOR AN APPOINTMENT ON (B)(6) 2018 WHERE THE PT WAS DIAGNOSED WITH INFECTIOUS CORNEAL ULCER. DURING TREATMENT THE PT WAS RECOMMENDED TO SUSPEND TEMPORARILY THE USE OF CONTACT LENSES. ON (B)(6) 2018, A NEW EVALUATION WAS DONE WHERE THE USE OF LENSES WAS PERMITTED¿. NO SUSPECT LENS HAS BEEN RECEIVED. 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 B00K8LF 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
    164475 ACUVUE OASYS FOR ASTIGMATISM LENSES, SOFT CONTACT, EXTENDED WEAR LPM JOHNSON & JOHNSON VISION CARE, INC. ¿ US NA B00K8LF

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R