BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE® VITA¿

    MDR report key: 13029104 · Received December 17, 2021

    Report

    Report Number
    1057985-2021-00179
    Event Type
    Injury
    Date Received
    December 17, 2021
    Date of Event
    July 1, 2021
    Report Date
    December 17, 2021
    Manufacturer
    JOHNSON & JOHNSON VISION CARE, INC. - US
    Product Code
    LPL
    PMA / PMN Number
    K160212
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUSPECT PRODUCT DISCARDED.

    Description of Event or Problem · 0

    ON (B)(6) 2021 AN EYE CARE PROVIDER (ECP) IN (B)(6) CALLED TO REPORT A PATIENT (PT) HAS SCARRING ON THE EYE (AFFECTED EYE IS UNKNOWN) WHILE WEARING THE ACUVUE® VITA¿ BRAND CONTACT LENSES (CLS). THE ECP ADVISED THE LENSES TORE ON THE PTS EYE. THE PT HAD TO VISIT A HOSPITAL, HAD AN ¿INFECTION¿ AND WORE EYEGLASSES FOR 2 WEEKS. THE PT WAS PRESCRIBED FLOXAL, FML LIQUID FILM, LACRY, TOBREX.. THE MEDICATION DETAILS AND FREQUENCY OF THE PRESCRIBED MEDICATION ARE UNKNOWN. THE REPORTING ECP DIDN¿T HAVE THE EXACT DATE THE PT VISITED THE HOSPITAL. THE ECP REPORTED THE EVENT OCCURRED SOMETIME AFTER (B)(6) 2021. NO ADDITIONAL MEDICAL INFORMATION WAS PROVIDED. ON (B)(6) 2021 ADDITIONAL MEDICAL INFORMATION WAS PROVIDED. THE AFFECTED EYE IS THE OD. THE PT WAS PRESCRIBED FLOXAL, FML LIQUID FILM, LACRY AND TOBREX FOR 14 DAYS. THE PT HAS NO LOSS OF VISUAL ACUITY AND HAS RETURNED TO CLS WEAR. THE PT CONTACTED THE ECP REGARDING THE EVENT ON (B)(6) 2021, BUT THE DATE OF THE EVENT WAS NOT PROVIDED. NO ADDITIONAL MEDICAL INFORMATION HAS BEEN RECEIVED. NO ADDITIONAL MEDICAL 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 B00X66P WAS PRODUCED UNDER NORMAL CONDITIONS. THE OD SUSPECT CLS WAS DISCARDED. NO ADDITIONAL EVALUATION CAN BE CONDUCTED. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1924726 ACUVUE® VITA¿ LENSES, SOFT CONTACT, DAILY WEAR LPL JOHNSON & JOHNSON VISION CARE, INC. - US B00X66P

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R