BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK-SOFT CONTACT LENSES

    MDR report key: 17949701 · Received October 17, 2023

    Report

    Report Number
    1057985-2023-00076
    Event Type
    Injury
    Date Received
    October 17, 2023
    Date of Event
    June 1, 2022
    Report Date
    October 17, 2023
    Manufacturer
    JOHNSON & JOHNSON VISION CARE, INC. - US
    Product Code
    LPL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : UNKNOWN IF SUSPECT PRODUCT IS AVAILABLE.

    Description of Event or Problem · 0

    ON (B)(6) 2023, AN ARTICLE TITLED, ¿COMPARISON OF OUTCOMES IN PATIENTS WITH AND WITHOUT SOFT CONTACT LENS WEAR FOLLOWING BOSTON KERATOPROSTHESIS TYPE 1¿ WAS REVIEWED BY A JOHNSON AND JOHNSON VISION CARE EMPLOYEE. THE ARTICLE SUMMARIZES A RETROSPECTIVE COHORT STUDY OF 99 PATIENTS WHO UNDERWENT BOSTON KERATOPROSTHESIS TYPE 1 (KPRO) SURGERY BETWEEN 2008 AND 2018. ALL SURGERIES WERE CONDUCTED BY THE SAME SURGEON AND PATIENTS WERE PROVIDED CARE BY THE SAME PRACTICE IN CANADA. THE SUMMARY OF THE ARTICLE REVEALS ALL PATIENTS WERE PLACED IN ONE OF THREE SOFT CONTACT LENSES (SCLS) POST OPERATIVELY. THREE SCL BRANDS WERE IDENTIFIED IN THE STUDY INCLUDING AN ACUVUE BRAND CONTACT LENS WITH A 14MM DIAMETER AND AN 8.4 MM BASE CURVE. THE SCLS WERE WORN ¿AROUND THE CLOCK FOR MONTHS.¿ PATIENTS WERE FOLLOWED FOR UP TO 5 YEARS POST-OPERATIVELY. THE STUDY LOOKED AT PATIENTS WHO CONTINUED TO WEAR THE SCLS VERSUS THOSE WHO DID NOT CONTINUE TO WEAR THE SCLS, CROSS COMPARED WITH 1-YEAR (SHORT-TERM) AND 5-YEAR (LONG-TERM) TIMELINE OF POST OPERATIVE WEAR. THE OBJECTIVE WAS TO DETERMINE IF USE OF SCLS HAD A STATISTICALLY SIGNIFICANT IMPACT ON PREVENTION OF POST-SURGICAL COMPLICATIONS. THE COMPLICATIONS INCLUDED IN THIS SUBMISSION ARE CONSIDERED SERIOUS ADVERSE EVENTS. A PORTION OF PATIENTS BOTH WITH AND WITHOUT SCLS EXPERIENCED THE EVENTS. THERE WAS NO IDENTIFYING INFORMATION PROVIDED FOR THE PATIENTS AND IT IS UNKNOWN WHICH SPECIFIC SCLS WERE WORN WHEN THE SUBJECTS EXPERIENCED ADVERSE EVENTS. ADVERSE EVENTS THAT OCCURRED POST OPERATIVELY AT BOTH THE 1-YEAR AND 5-YEAR FOLLOW-UP WERE DOCUMENTED. THE ADVERSE EVENTS INCLUDE: ENDOPHTHALMITIS, STERILE VITRITIS, INFECTIOUS KERATITIS, RETROPROSTHETIC MEMBRANE, CORNEAL MELT, KPRO EXTRUSION, AND AQUEOUS HUMOUR LEAKAGE. THE STUDY CONCLUDED THERE WAS NOT A STATISTICALLY SIGNIFICANT PROTECTIVE EFFECT OF SCL WEAR AGAINST THE INCIDENCE OF POSTOPERATIVE COMPLICATIONS IN LONG-TERM FOLLOW UP. NO ADDITIONAL MEDICAL INFORMATION HAS BEEN RECEIVED. NO ADDITIONAL MEDICAL INFORMATION IS EXPECTED. THE EVENT DATE WILL BE LISTED AS (B)(6) 2022 (DATE THE STUDY WAS PUBLISHED) AS THE ACTUAL DATE OF EVENT IS UNKNOWN. IT IS UNKNOWN WHICH ACUVUE BRAND CONTACT LENS WAS USED DURING THE STUDY; THEREFORE, UNKNOWN ACUVUE BRAND CONTACT LENS IS BEING REPORTED. IT IS UNKNOWN IF THE SUSPECT CL(S) AND LOT NUMBER ARE AVAILABLE. NO ADDITIONAL EVALUATION CAN BE PERFORMED. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2053469 UNK-SOFT CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR LPL JOHNSON & JOHNSON VISION CARE, INC. - US UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O