BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS

    MDR report key: 8805140 · Received July 18, 2019

    Report

    Report Number
    1057985-2019-00063
    Event Type
    Injury
    Date Received
    July 18, 2019
    Report Date
    July 16, 2019
    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) 2019 A PATIENT IN (B)(6) CALLED TO REPORT A DIAGNOSIS OF ¿INFECTIOUS CONJUNCTIVITIS¿ IN 2014 WHILE WEARING THE ACUVUE OASYS BRAND CONTACT LENSES. THE PT REPORTED OS ITCHING, TEARING, PHOTOPHOBIA, REDNESS, AND DISCHARGE. THE PT WENT TO AN EYE CARE PROVIDER (ECP) WHO DIAGNOSED THE PT WITH OS ¿INFECTIOUS CONJUNCTIVITIS¿. THE PT WAS PRESCRIBED CYLODEX TID FOR 5 DAYS. PT REPORTED THE OS WAS BETTER IN 4 DAYS. THE PT REPORTED THE LENSES WERE WORN AS DAILY WEAR WITH A REPLACEMENT SCHEDULE OF 40 DAYS. THE PT USED OPTI-FREE OR RENU SOLUTION TO DISINFECT THE LENSES. THE LOT NUMBER IS UNKNOWN AND THE SUSPECT LENSES WERE DISCARDED. THE PT IS UNABLE TO PROVIDE THE TREATING ECP AT THE TIME OF THE EVENT. NO ADDITIONAL MEDICAL OR PRODUCT INFORMATION IS AVAILABLE. THIS OS EVENT IS BEING REPORTED AS A WORST-CASE EVENT AS THE DIAGNOSIS AND TREATMENT WERE UNABLE TO BE VERIFIED WITH THE PTS TREATING ECP. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598860 ACUVUE OASYS LENSES, SOFT CONTACT, EXTENDED WEAR LPM JOHNSON & JOHNSON VISION CARE, INC. ¿ US NA UNK-PH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R