BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE BRAND MULTI-PURPOSE SOLUTION

    MDR report key: 11953293 · Received June 7, 2021

    Report

    Report Number
    3004178847-2021-07007
    Event Type
    Injury
    Date Received
    June 7, 2021
    Date of Event
    May 8, 2021
    Report Date
    June 7, 2021
    Manufacturer
    AMO(HANGZHOU) CO., LTD.
    Product Code
    LPN
    PMA / PMN Number
    K014202
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO: UNKNOWN, INFORMATION NOT PROVIDED. LOT NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS LOT NUMBER WAS NOT PROVIDED. UNIQUE DEVICE IDENTIFIER (UDI #): UNKNOWN, AS LOT NUMBER WAS NOT PROVIDED. (B)(6). THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THERE WAS NO LOT NUMBER REPORTED FOR THIS DEVICE. THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED, IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN AS SERIAL NUMBER WAS NOT PROVIDED. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO FURTHER INFORMATION HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE CONSUMER FELT PAIN IN HER EYE ON (B)(6) 2021 AFTER SHE WORE A CONTACT LENS THAT HAD BEEN CARED FOR USING COMPLETE DOUBLE MOIST. CONSUMER HAS EXPERIENCED DISCOMFORT SINCE THEN, AND CONSULTED AN OPHTHALMOLOGIST ON (B)(6) 2021. THE OPHTHALMOLOGIST OBSERVED THAT BOTH HER LENS AND EYE HAD BEEN SCRATCHED, AND DIAGNOSED THE CONSUMER WITH CONJUNCTIVITIS. THE EXACT CAUSE OF HE CONJUNCTIVITIS IS UNKNOWN. CONSUMER COULD NOT PROVIDE IF LENS WORN ON (B)(6) WAS A DAILY WEAR OR A BI-WEEKLY LENS. THE CONSUMER WILL NOT RETURN THE PRODUCT FOR EXCHANGE. THE CURRENT STATE OF THE IMPACTED EYE WAS PROVIDED AS FOLLOWS: PAIN HAS SUBSIDED, BUT SYMPTOM IS STILL LASTING AS CONSUMER HAS JUST CONCLUDED THEIR OPHTHALMOLOGIST VISIT TODAY, AND HAS YET TO USE ANY OF THE PRESCRIBED MEDICINES. THREE TYPES OF DRUGS WERE PRESCRIBED, BUT NO NAMES PROVIDED, ONLY THAT ONE IS AN ANTIBACTERIAL OPHTHALMIC SOLUTION, ANOTHER WAS AN OPHTHALMIC SOLUTION TO PREVENT DRYNESS, AND THE THIRD IS A TUBE OINTMENT TO CURE CONJUNCTIVITIS. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841578 COMPLETE BRAND MULTI-PURPOSE SOLUTION ACCESSORIES, SOFT LENS PRODUCTS LPN AMO(HANGZHOU) CO., LTD. 8941X UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention