BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSEPT 1-STEP

    MDR report key: 10659871 · Received October 10, 2020

    Report

    Report Number
    3004178847-2020-00023
    Event Type
    Injury
    Date Received
    October 10, 2020
    Report Date
    November 5, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    LPN
    PMA / PMN Number
    P850088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN THE INITIAL MDR SECTION H6 PATIENT CODE 2146 WAS PROVIDED, HOWEVER THE APPROPRIATE CODE FOR IRRITATION IS 1941. THEREFORE, THE CODE IS BEING UPDATED IN THIS SUPPLEMENTAL FILING.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: DATE OF EVENT: EXACT DATE UNKNOWN, INFORMATION NOT PROVIDED. BEST ESTIMATE IS TWO DAYS PRIOR TO THE EVENT BEING REPORTED TO J&J. (B)(6) 2020. LOT#: UNKNOWN, INFORMATION NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS THE LOT# WAS NOT PROVIDED. UNIQUE IDENTIFIER: UNKNOWN, AS THE LOT# WAS NOT PROVIDED. DEVICE MANUFACTURED DATE: UNKNOWN, AS THE LOT# WAS NOT PROVIDED. CONCOMITANT MEDICAL PRODUCTS: CONSEPT 1-STEP NEUTRALIZING TABLET LOT# 84066 OR LOT# 82358, EXACT LOT# USED WITH SOLUTION AT THE TIME OF THE EVENT IS UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CONSUMER REPORTED THAT AFTER USING CONCEPT 1-STEP PRODUCT, HER EYES WERE SEVERELY IRRITATED WHEN WEARING HER CONTACT LENSES. CONSUMER EXPLAINED THAT WHEN SHE ADDED THE NEUTRALIZING TABLET TO THE SOLUTION, BUBBLES SUDDENLY GENERATED. ONE MINUTE AFTER ADDING THE NEUTRALIZING TABLET THE SOLUTION WOULD BUBBLE AND THE TABLET WOULD COMPLETELY DISSOLVE. WHENEVER THIS OCCURRED, SHE ALWAYS TRIED AGAIN TO ENSURE SHE IS TAKING CARE OF HER LENSES APPROPRIATELY. TWO DAYS PRIOR TO THIS REPORT THE PATIENT EXPERIENCED IRRITATION IN HER RIGHT EYE EVEN THOUGH SHE TOOK THE APPROPRIATE STEPS. REPORTEDLY, HER CONTACTS WERE LEFT IN THE SOLUTION ABOUT SEVEN HOURS PRIOR TO USE AND THAT SHE DID ADD THE NEUTRALIZING TABLET TO THE SOLUTION AS THE COLOR TURNED PINK WHEN SHE CHECKED. THIS OCCURRED FIVE TIMES, AND THE SAME CONTACT LENS CASE HAS BEEN USED FOR MORE THAN SIX MONTHS. AS OF THE TIME OF REPORTING THIS EVENT, THE CONSUMER COULD NOT WEAR CONTACT LENSES. SHE HAD SOUGHT MEDICAL ATTENTION AND THE OPHTHALMOLOGIST PRESCRIBED AN OPHTHALMIC SOLUTION. THROUGH FOLLOW-UP IT WAS LEARNED THE CONSUMER WAS PRESCRIBED HYALURONATE NA OPHTHALMIC SOLUTION AND LEVOFLOXACIN OPHTHALMIC SOLUTION. THE CONSUMER¿S CONDITION HAS NOW RESOLVED. NO FURTHER INFORMATION WAS PROVIDED. TWO DIFFERENT LOTS-BOTTLES OF SOLUTION AND TWO DIFFERENT LOTS OF TABLETS WERE USED. THEREFORE, FOUR SEPARATE REPORTS ARE BEING SUBMITTED FOR THIS EVENT, ONE FOR EACH PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124422 CONSEPT 1-STEP SOLUTIONS LPN JOHNSON & JOHNSON SURGICAL VISION, INC. 07167X UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention