BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFINITY MULTIFOCAL (COMFILCON A)

    MDR report key: 17904540 · Received October 10, 2023

    Report

    Report Number
    9614392-2023-00029
    Event Type
    Injury
    Date Received
    October 10, 2023
    Date of Event
    September 23, 2023
    Report Date
    November 28, 2023
    Manufacturer
    COOPERVISION MANUFACTURING, LTD.
    Product Code
    LPM
    PMA / PMN Number
    P080011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NEW RELEVANT MEDICAL INFORMATION RECEIVED 19 OCTOBER 2023. NO PRODUCT HAS BEEN MADE AVAILABLE FOR MANUFACTURER ANALYSIS. LOT NUMBER WAS PROVIDED FOR THE DEVICE ALLEGED TO BE INVOLVED IN THE INCIDENT. BASED ON INVESTIGATION NO ROOT CAUSE COULD BE ESTABLISHED. THE RELATIONSHIP BETWEEN THE COOPERVISION DEVICE AND THE INCIDENT IS UNCONFIRMED. MANUFACTURERS INCIDENT REPORT IS UPDATED TO REFLECT NEW DETAILS AND THE RESULTS OF DEVICE MANUFACTURING RECORDS REVIEW. THIS IT IS UNKNOWN IF THIS INCIDENT INVOLVES BOTH RIGHT AND LEFT EYE AND PATIENT WAS WEARING A DIFFERENT DEVICE IN EACH EYE. PLEASE REFER TO LINKED MANUFACTURER REPORT (B)(4) 9614392-2023-00028-1 FOR SECOND ASSOCIATED INCIDENT REPORT.

    Additional Manufacturer Narrative · 0

    MANUFACTURERS INVESTIGATION OF THE RETURNED DEVICE AND MANUFACTURING RECORDS FOUND NO FAILURES OR NONCONFORMANCES AND NO TRENDS WERE IDENTIFIED. NO ROOT CAUSE COULD BE ESTABLISHED, THE RELATIONSHIP BETWEEN THE COOPERVISION DEVICE AND THE INCIDENT IS UNCONFIRMED. DEVICE SAMPLE RETURNED FOR ANALYSIS, RECEIVED 07 NOVEMBER 2023 AND INVESTIGATION COMPLETED 14 NOVEMBER 2023. FOR UPDATED DATA REFER TO THE FOLLOWING SECTIONS: (B4), (B6), (D9), (G2), (G3), (G6), (H2), (H3), (H6), (H10). THIS IT IS UNKNOWN IF THIS INCIDENT INVOLVES BOTH RIGHT AND LEFT EYE AND PATIENT WAS WEARING A DIFFERENT DEVICE IN EACH EYE. PLEASE REFER TO LINKED MANUFACTURER REPORT (B)(4), 9614392-2023-00028-2 FOR SECOND ASSOCIATED INCIDENT REPORT.

    Additional Manufacturer Narrative · 0

    (SEE H3) NO PRODUCT HAS BEEN MADE AVAILABLE FOR MANUFACTURER ANALYSIS AND NO LOT NUMBER PROVIDED FOR MANUFACTURER INVESTIGATION. GIVEN THE LACK OF AVAILABLE DEVICE INFORMATION, THE MANUFACTURER IS UNABLE TO COMPLETE FURTHER INVESTIGATIONS AT THIS TIME AND NO ROOT CAUSE CAN BE ESTABLISHED. THE RELATIONSHIP BETWEEN THE COOPERVISION DEVICE AND THE EVENT IS UNCONFIRMED. SHOULD FURTHER INFORMATION BECOME AVAILABLE, THE MANUFACTURER WILL COMPLETE FURTHER INVESTIGATIONS AS APPROPRIATE AND SUBMIT A FOLLOW-UP REPORT AS APPLICABLE. THIS IT IS UNKNOWN IF THIS INCIDENT INVOLVES BOTH RIGHT AND LEFT EYE AND PATIENT WAS WEARING A DIFFERENT DEVICE IN EACH EYE. PLEASE REFER TO LINKED MANUFACTURER REPORT CC538473 9614392-2023-00028 FOR SECOND ASSOCIATED INCIDENT REPORT.

    Description of Event or Problem · 0

    THIS INCIDENT WAS INITIALLY REPORTED UNDER 9614392-2023-00029 ON 19 SEPTEMBER 2023 AS AN ALLEGED CORNEAL ULCER WITHOUT SUPPORTING INFORMATION. NEW RELEVANT INFORMATION WAS RECEIVED ON 19 OCTOBER 2023. THE INFORMATION PROVIDED STATES THE PATIENT SOUGHT MEDICAL ATTENTION (B)(6) 2023 DUE TO A STUCK LENS IN THE LEFT (OS) EYE. DURING THE EXAMINATION, BULBAR INJECTION, TARSAL PAPILLAE, AND EPITHELIAL STAINING WERE OBSERVED. NO ADDITIONAL INFORMATION WAS PROVIDED ON THE INCIDENT OR INJURY AND NO FORMAL DIAGNOSIS WAS PROVIDED. AS PART OF THE PATIENT'S TREATMENT PLAN, THE PATIENT WAS PRESCRIBED A PRESERVATIVE FREE EYEWASH SOLUTION (DACUDOSES), ANTISEPTIC EYE DROPS (VITABACT), AND SODIUM HYALURONATE EYE LUBRICANT (VISMED). THERE IS NO INFORMATION PROVIDED ON THE INITIALLY REPORTED INJURY OF CORNEAL ULCER OR CORNEAL DETACHMENT, THE DETAILS OF THAT ALLEGED EVENT REMAIN UNKNOWN. INFORMATION PROVIDED INDICATES THE PATIENT WAS USING A DIFFERENT DEVICE IN EACH EYE. WHILE THIS NEW INFORMATION INDICATES INVOLVEMENT OF THE LEFT EYE ONLY, IT IS UNKNOWN WHICH DEVICE WAS BEING WORN IN THAT EYE. PLEASE REFER TO LINKED MANUFACTURER REPORT (B)(6) 9614392-2023-00028-1 FOR SECOND ASSOCIATED INCIDENT REPORT.

    Description of Event or Problem · 0

    THIS INCIDENT WAS RECEIVED BY THE HEALTHCARE PROFESSIONAL AND LIMITED INFORMATION HAS BEEN MADE AVAILABLE. ACCORDING TO THE DETAILS PROVIDED, THE PATIENT EXPERIENCED WHAT IS DESCRIBED AS CORNEAL ULCER OR CORNEAL DETACHMENT. AS OF THE DATE OF THIS REPORT ADDITIONAL INFORMATION IS UNKNOWN. THIS EVENT IS BEING REPORTED WITH AN ABUNDANCE OF CAUTION DUE TO THE UNKNOWN OR UNCLEAR DIAGNOSIS WITH UNKNOWN NATURE OR SEVERITY OF THE INCIDENT, LACK OF SUPPORTING MEDICAL INFORMATION AND UNKNOWN PATIENT RESOLUTION. SHOULD FURTHER INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPROPRIATE. THIS IT IS UNKNOWN IF THIS INCIDENT INVOLVES BOTH RIGHT AND LEFT EYE AND PATIENT WAS WEARING A DIFFERENT DEVICE IN EACH EYE. PLEASE REFER TO LINKED MANUFACTURER REPORT CC538473 9614392-2023-00028 FOR SECOND ASSOCIATED INCIDENT REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283155 BIOFINITY MULTIFOCAL (COMFILCON A) BIOFINITY MULTIFOCAL (COMFILCON A) LPM COOPERVISION MANUFACTURING, LTD. 10612070121511

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Other