BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1-DAY ACUVUE MOIST

    MDR report key: 10651449 · Received October 8, 2020

    Report

    Report Number
    1057985-2020-00052
    Event Type
    Injury
    Date Received
    October 8, 2020
    Date of Event
    August 26, 2020
    Report Date
    October 8, 2020
    Manufacturer
    JOHNSON & JOHNSON VISION CARE, INC. ¿ US
    Product Code
    LPL
    PMA / PMN Number
    N18033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON 15 SEP 2020, AN EMAIL WAS RECEIVED FROM A DISTRIBUTOR WHO REPORTED A PATIENT (PT) COMPLAINT OF ¿BODILY INJURY¿ WHILE WEARING 1-DAY ACUVUE® MOIST® BRAND CONTACT LENSES. DATE OF INJURY IS NOTED AS (B)(6) 2020. ON (B)(6) 2020, THE PT WAS CONTACTED, AND ADDITIONAL INFORMATION WAS RECEIVED: THE PT REPORTED VISITING AN OPHTHALMOLOGIST THE WEEK BEFORE LAST (UNSPECIFIED DATE), WHO DIAGNOSED THE PT WITH A ¿BACTERIAL EYE INFECTION¿ IN THE LEFT EYE (OS) WITH ¿HUGE GOBS OF YELLOW STUFF¿ COMING FROM THE EYE. THE PT WAS PRESCRIBED ¿CIPRO TWICE A DAY.¿ THE PT IS CURRENTLY WEARING LENSES AGAIN. THE PT VISITED AN OPTOMETRIST LAST SATURDAY WHO ADVISED THE EYE WAS RED AND DRY. NO FURTHER INFORMATION WAS PROVIDED. ON (B)(6) 2020, A REPRESENTATIVE AT THE OPTOMETRIST OFFICE WAS CONTACTED AND PROVIDED THE FOLLOWING INFORMATION: THE OPTOMETRIST REPRESENTATIVE REPORTED THAT THE PT IS A KNOWN CONTACT LENS ABUSER AND WAS CLEANING DAILY LENSES AND RE-USING THEM. PT IS CURRENTLY PRESCRIBED A BRAND OF DAILY DISPOSABLE CONTACT LENSES FROM A DIFFERENT COMPANY. NO FURTHER INFORMATION WAS PROVIDED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO THE TREATING OPHTHALMOLOGIST, OPTOMETRIST, AND PT TO OBTAIN ADDITIONAL MEDICAL INFORMATION AND LOT NUMBER. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. THE SUSPECT OS CONTACT LENS IS NOT AVAILABLE FOR RETURN. NO PRODUCT OR LOT INFORMATION WAS AVAILABLE. NO ANALYSIS COULD 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
    1114250 1-DAY ACUVUE MOIST LENSES, SOFT CONTACT, DAILY WEAR LPL JOHNSON & JOHNSON VISION CARE, INC. ¿ US NA UNK-1DM

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other| R