BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS

    MDR report key: 7484135 · Received May 3, 2018

    Report

    Report Number
    9617710-2018-05031
    Event Type
    Injury
    Date Received
    May 3, 2018
    Report Date
    April 11, 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 · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2018, A PATIENT (PT) FROM (B)(6) CALLED TO REPORT EXPERIENCING BLURRY VISION AND ITCHING IN THE LEFT EYE (OS) WHILE WEARING ACUVUE OASYS CONTACT LENSES (CLS). THE PT STATED THAT THE EVENT FIRST HAPPENED IN (B)(6) 2018. THE PT PRESENTED TO THE EYE CARE PROFESSIONAL (ECP) AND WAS DIAGNOSED WITH PALPEBRAL CONJUNCTIVITIS AND ¿BACTERIA IN THE EYE¿. TWO MEDICATIONS WERE PRESCRIBED, EYE DROPS AND A CREAM (NAMES, DOSAGE, FREQUENCY, AND DURATION WERE UNKNOWN), AND CL WEAR WAS SUSPENDED FOR 10 DAYS. THE PT STATED THAT THE CL APPEARED ¿DIRTY¿ AND THE CL HAD ¿THE FORMAT OF HER EYE¿ UPON REMOVAL. THE PT USED A MULTI-PURPOSE SOLUTION TO CLEAN THE CLS. THE PT STATED THAT AFTER THE TREATMENT WAS COMPLETED, ACUVUE OASYS CLS WERE USED WITHOUT FURTHER ISSUE. PT REFUSED TO PROVIDE ECP INFORMATION. ON (B)(6) 2018, THE PT WAS CONTACTED AND STATED THAT THE PT VISITED THE ECP ON (B)(6) 2018 AND WAS PRESCRIBED MAXIFLOX-D (CIPROFLOXACIN/DEXAMETASONE) 1 GTT EVERY 3 HRS FOR 10 DAYS. THE PT DID NOT HAVE THE INFORMATION FOR THE OTHER MEDICATION AVAILABLE. THE PT STATED THAT THE OS WAS BETTER AFTER 5-6 DAYS WITH USE OF THE MEDICATION. THE PT STATED THAT THE ECP FOLLOW-UP VISIT WAS AFTER THE 10 DAYS OF MEDICATION AND AT THAT TIME THE PT WAS CLEARED TO RETURN TO CL WEAR. THE PT SUCCESSFULLY RETURNED TO CL WEAR ON EITHER (B)(6) 2018 OR (B)(6) 2018. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN MORE INFORMATION FROM THE PT, BUT WERE UNSUCCESSFUL. NO FURTHER INFORMATION WAS PROVIDED. THE SUSPECT PRODUCT IS NOT AVAILABLE FOR RETURN, AS IT WAS DISCARDED. 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 L003488 WAS PRODUCED UNDER NORMAL CONDITIONS. IF ADDITIONAL INFORMATION IS RECEIVED, WILL REPORT 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
    326304 ACUVUE OASYS LENSES, SOFT CONTACT, EXTENDED WEAR LPM JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND NA L003488

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R