BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SOLUTION

    MDR report key: 12565547 · Received October 1, 2021

    Report

    Report Number
    2020664-2021-07594
    Event Type
    Injury
    Date Received
    October 1, 2021
    Date of Event
    September 2, 2021
    Report Date
    November 24, 2021
    Manufacturer
    AMO(HANGZHOU) CO., LTD.
    Product Code
    LPN
    PMA / PMN Number
    K014202
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED AT THE MANUFACTURING SITE; THEREFORE, PRODUCT TESTING COULD NOT BE PERFORMED AND THE CUSTOMER¿S REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORD EVALUATION: BASED ON THE MANUFACTURING RECORDS REVIEW, AND HISTORICAL COMPLAINT REVIEW, THERE IS NO INDICATION OF A PRODUCT MALFUNCTION OR PRODUCT QUALITY DEFICIENCY. NO NONCONFORMITY REPORT, DOCUMENTATION OR LABELING CHANGES, AND ESCALATIONS ARE REQUIRED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AGE OR DOB, WEIGHT, ETHNICITY: UNKNOWN/ NOT PROVIDED. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    REPORT WAS RECEIVED THAT A FEMALE CONSUMER EXPERIENCED DISCOMFORT UPON INSERTION OF HER CONTACT LENSES AFTER USING COMPLETE MULTIPURPOSE SOLUTION FOR THE FIRST TIME. ADDITIONALLY, SHE EXPERIENCED TEARING AND REDNESS, AND COULD NOT OPEN HER EYES PROPERLY THIS MORNING. THE CONSUMER SOUGHT MEDICAL ATTENTION AND THE PHYSICIAN USED STROKE-PHYSIOLOGICAL SALINE SOLUTION TO CLEAN OUT HER EYES, AND THEY ARE BETTER NOW. IT IS REPORTED THE DIRECTIONS FOR USE WERE FOLLOWED, THE PRODUCT WAS JUST OPEN THE DAY OF USE. CONTACT LENSES USED ARE SOFT LENSES, AND NEITHER THE LENSES NOR LENS CASE WERE RINSED WITH WATER. THE PHYSICIAN DID NOT PRESCRIBE MEDICATIONS FOR THIS EVENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1458896 COMPLETE SOLUTION ACCESSORIES, SOFT LENS PRODUCTS LPN AMO(HANGZHOU) CO., LTD. 08772X ZJ05027

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention SOFT CONTACT LENSES BRAND UNKNOWN