BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS FOR ASTIGMATISM

    MDR report key: 5029342 · Received August 25, 2015

    Report

    Report Number
    1033553-2015-00052
    Event Type
    Injury
    Date Received
    August 25, 2015
    Report Date
    November 13, 2015
    Manufacturer
    JOHNSON & JOHNSON VISION CARE, INC. ¿ US
    Product Code
    LPM
    PMA / PMN Number
    P040045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT REFLECTS THAT THE PRODUCT WAS MANUFACTURED: JOHNSON AND JOHNSON VISION CARE, INC. (B)(4). THE CORRECT MANUFACTURE ADDRESS IS: JOHNSON AND JOHNSON VISION CARE INC. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR ADVISED THAT "ON (B)(6) 2015 OUR AFFILIATE IN (B)(6) ADVISED THAT A CALL WAS PLACED TO THE PT'S ECP WHO ADVISED THE FOLLOWING INFORMATION: "PT EXPERIENCED REDNESS, ITCHING, AND WATERING ON OU WHEN WEARING CL." THE ERROR IN THE DATE WAS NOTED AS THE FILE WAS REVIEWED ON (B)(6) 2015. THE CORRECT DATE IS: (B)(6) 2015.

    Additional Manufacturer Narrative · 1

    RECEIVED FIVE SEALED BLISTERS. THE PARAMETERS OF THE FIVE SEALED LENSES WERE MEASURED AND A VISUAL INSPECTION WAS PERFORMED. THE LENSES MEET COMPANY STANDARDS FOR BASE CURVE, CENTER THICKNESS, AND DIAMETER. NO OTHER VISUAL ATTRIBUTES WERE OBSERVED. THE SOLUTION WAS ALSO TESTED. THE PH AND CONDUCTIVITY WERE IN SPECIFICATION. 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).

    Description of Event or Problem · 1

    ON (B)(6) 2015 WE WERE ADVISED BY OUR AFFILIATE IN (B)(4) THAT A CALL WAS RECEIVED FROM A PATIENT'S (PT) FAMILY MEMBER STATING THAT THE "PT EXPERIENCED IRRITATION AND INFECTION WEARING CONTACT LENS (CL) ON OU." THE PT'S FAMILY MEMBER ADVISED THAT THE "PT'S EYES WERE INFECTED AFTER REMOVAL OF LENSES." THE PT WEARS ACUVUE OASYS FOR ASTIGMATISM LENSES IN THE OD. THE FAMILY MEMBER ADVISED THAT THE PT VISITED AN EYE CARE PROVIDER (ECP) "AND IS UNDERGOING TREATMENT AND TAKING MEDICINE." ON (B)(6) 2015 OUR AFFILIATE IN (B)(4) ADVISED THAT A CALL WAS PLACED TO THE PT'S ECP WHO ADVISED THE FOLLOWING INFORMATION: "PT EXPERIENCED REDNESS, ITCHING, AND WATERING ON OU WHEN WEARING CL." THE ECP ADVISED THE AFFILIATE THAT THE PT HAD "INFECTION ON BOTH EYES." THE ECP ALSO ADVISED THAT THE "PT WAS USING ANTIBIOTICS AND NOW FEEL COMFORTABLE." THE DATE OF THE EVENT REPORTED AS (B)(6) 2015. IT WAS ADVISED THAT THE PT WAS AN EXPERIENCED WEARER. THE PRODUCT WAS REQUESTED FOR RETURN FOR EVALUATION, BUT IT HAS NOT YET BEEN RECEIVED. SEVERAL ATTEMPTS WERE MADE TO CONTACT THE PT FOR ADDITIONAL INFORMATION, BUT THE ATTEMPTS WERE UNSUCCESSFUL. THIS REPORT IS TO CAPTURE THE OD AS A WORST CASE. THE EVENT FOR THE OS IS BEING CAPTURED ON A SEPARATE REPORT. A LOT HISTORY REVIEW WAS PERFORMED FOR LOT # L002LH6 AND REVEALED THE BATCH DID NOT SHOW ANY ABNORMALITIES IN MONOMER AND SOLUTION TESTING. ALL PARAMETERS TESTED WERE WITHIN SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE SUCCESSFULLY COMPLETED. 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
    561360 ACUVUE OASYS FOR ASTIGMATISM LENSES, SOFT CONTACT, EXTENDED WEAR LPM JOHNSON & JOHNSON VISION CARE, INC. ¿ US L002LH6

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R