BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUTRIFILL

    MDR report key: 20994863 · Received December 20, 2024

    Report

    Report Number
    3016114779-2024-00012
    Event Type
    Injury
    Date Received
    December 20, 2024
    Date of Event
    September 1, 2024
    Report Date
    December 12, 2024
    Manufacturer
    ASEPT PAK
    Product Code
    MRC
    UDI-DI
    00850012123002
    PMA / PMN Number
    K181566
    Removal / Correction Number
    96900
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH PATIENT USED SEVERAL PRODUCTS AND INITIAL INVESTIGATION OF NUTRIFILL HAS SHOWN NO ABNORMALITIES, PATIENT INDICATED THAT ONE VIAL WOULD LAST FOR 2-3 DAYS OF APPLICATION/WEAR. SAVING AND REUSING A SINGLE-USE PRESERVATIVE FREE AMPOULE COULD INTRODUCE BACTERIA INTO THE CONTACT LENS WEARING ENVIRONMENT AND CAUSE INFECTION. SINGLE-USE AMPOULES ARE MEANT TO BE DISCARDED IMMEDIATELY AFTER USE AS INSTRUCTED ON PACKAGING. IT IS POSSIBLE THAT PATIENT MISUSE INTRODUCED INFECTION.

    Additional Manufacturer Narrative · 0

    ALTHOUGH PATIENT USED SEVERAL PRODUCTS AND INITIAL INVESTIGATION OF NUTRIFILL HAS SHOWN NO ABNORMALITIES, PATIENT INDICATED THAT ONE VIAL WOULD LAST FOR 2-3 DAYS OF APPLICATION/WEAR. SAVING AND REUSING A SINGLE-USE PRESERVATIVE FREE AMPOULE COULD INTRODUCE BACTERIA INTO THE CONTACT LENS WEARING ENVIRONMENT AND CAUSE INFECTION. SINGLE-USE AMPOULES ARE MEANT TO BE DISCARDED IMMEDIATELY AFTER USE AS INSTRUCTED ON PACKAGING. IT IS POSSIBLE THAT PATIENT MISUSE INTRODUCED INFECTION. UPDATE: INFORMATION RECEIVED LATER FROM THE MANUFACTURER, INCLUDING THE RETESTING OF 4 DIFFERENT SETS OF SAMPLES (RETAINED SAMPLES AND SAMPLES COLLECTED FROM THE FIELD) HAS INDICATED 2 SETS OF SAMPLES WERE NON-STERILE. MISUSE COULD HAVE CONTRIBUTED TO THE SYMPTOMS, BUT WE NOW ARE UNABLE TO CONFIRM THE STERILITY OF LOT HFH. THIS LOT IS BEING RECALLED.

    Description of Event or Problem · 0

    PATIENT (B)(6) CONTACTED THE COMPANY ON 11/13/2024 INDICATING THEY HAD RECENTLY BEEN TREATED FOR SEVERAL INFECTIONS. ON 11/14 (B)(6) AGREED TO A PHONE CALL TO DESCRIBE THE EVENT(S). (B)(6) BEGAN WEARING SCLERAL LENSES FOR KERATOCONUS IN (B)(6) OF 2024 (POST CORNEAL TRANSPLANT). (B)(6) USED UNIQUEPH DISINFECTING SOLUTION, NUTRIFILL SALINE SOLUTION FOR FILLING THEIR SCLERAL LENSES, AND SYSTANE PF DROPS AND AN UNKNOWN SALINE TO OCCASIONALLY RINSE LENSES. (B)(6) INDICATED THAT THEY WOULD USE ONE VIAL OF NUTRIFILL FOR 2-3 DAYS. SOMETIME IN AUGUST (B)(6) BEGAN TO EXPERIENCE IRRITATION, REDNESS AND PAIN OU WHEN WEARING LENSES. BY THE END OF AUGUST (B)(6) VISTED THEIR OPHTHAMOLOGIST FOR AN EMERGENCY VISIT. (B)(6) WAS ADVISED THEY HAD AN INFECTION FROM THEIR CONTACT LENSES AND WERE PRESCRIBED MOXYFLOXACIN AND TOLD TO DISCONTINUE WEAR FOR 10 DAYS UNTIL SYMPTOMS RESOLVED. (B)(6) RESUMED WEAR AFTER THE ADVISED TIME PERIOD AND IMMEDIATELY THE SYMPTOMS RESUMED AND THE OPTHTHAMOLOGIST AGAIN ADVICED TO DISCONTINUE CONTACT LENS WEAR, PRESCRIBED MOXYFLOXACIN AND REVIEWED DISINFECTION OF CONTACT LENSES AND TO REPLACE THEIR CONTACT LENS CASE AND SUGGESTED USING CLEARCARE TO DISINFECT LENSES. AFTER SSEING THEIR OPTOMETRIST (B)(6) RESUMED CONTACT LENS WEAR USING LACRIPURE FOR THEIR FILLING SOLUTION AND USING CLEARCARE ONCE A WEEK TO DISINFECT AND HAS NOT HAD ANY ISSUES SINCE. (B)(6) THEN CONTACTED CONTAMAC SOLUTIONS AND PROVIDED INFORMATION ABOUT THE ADVERSE EVENT AND SHARED THAT THEY HAD BEEN USING LOT NUMBER HFH (PURCHASED IN JULY 2024) AND SENT 4 UNOPENED VIALS AND 2 VIALS THAT HAD BEEN OPEN IN A ZIP-LOC BAG FOR TESTING.

    Description of Event or Problem · 0

    PATIENT (B)(6) CONTACTED THE COMPANY ON (B)(6) 2024 INDICATING THEY HAD RECENTLY BEEN TREATED FOR SEVERAL INFECTIONS. ON (B)(6) AGREED TO A PHONE CALL TO DESCRIBE THE EVENT(S). (B)(6) BEGAN WEARING SCLERAL LENSES FOR KERATOCONUS IN (B)(6) 2024 (POST CORNEAL TRANSPLANT). (B)(6) USED UNIQUEPH DISINFECTING SOLUTION, NUTRIFILL SALINE SOLUTION FOR FILLING THEIR SCLERAL LENSES, AND SYSTANE PF DROPS AND AN UNKNOWN SALINE TO OCCASIONALLY RINSE LENSES. (B)(6) INDICATED THAT THEY WOULD USE ONE VIAL OF NUTRIFILL FOR 2-3 DAYS. SOMETIME IN (B)(6) BEGAN TO EXPERIENCE IRRITATION, REDNESS AND PAIN OU WHEN WEARING LENSES. BY THE END OF (B)(6) VISTED THEIR OPHTHAMOLOGIST FOR AN EMERGENCY VISIT. (B)(6) WAS ADVISED THEY HAD AN INFECTION FROM THEIR CONTACT LENSES AND WERE PRESCRIBED MOXYFLOXACIN AND TOLD TO DISCONTINUE WEAR FOR 10 DAYS UNTIL SYMPTOMS RESOLVED. (B)(6) RESUMED WEAR AFTER THE ADVISED TIME PERIOD AND IMMEDIATELY THE SYMPTOMS RESUMED AND THE OPTHTHAMOLOGIST AGAIN ADVICED TO DISCONTINUE CONTACT LENS WEAR, PRESCRIBED MOXYFLOXACIN AND REVIEWED DISINFECTION OF CONTACT LENSES AND TO REPLACE THEIR CONTACT LENS CASE AND SUGGESTED USING CLEARCARE TO DISINFECT LENSES. AFTER SSEING THEIR OPTOMETRIST (B)(6) RESUMED CONTACT LENS WEAR USING LACRIPURE FOR THEIR FILLING SOLUTION AND USING CLEARCARE ONCE A WEEK TO DISINFECT AND HAS NOT HAD ANY ISSUES SINCE. (B)(6) THEN CONTACTED CONTAMAC SOLUTIONS AND PROVIDED INFORMATION ABOUT THE ADVERSE EVENT AND SHARED THAT THEY HAD BEEN USING LOT NUMBER HFH (PURCHASED IN (B)(6) 2024) AND SENT 4 UNOPENED VIALS AND 2 VIALS THAT HAD BEEN OPEN IN A ZIP-LOC BAG FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2617483 NUTRIFILL NUTRIFILL MRC ASEPT PAK HFH 00850012123002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention SCLERAL LENS (UNKNOWN).| SCLERAL LENS (UNKNOWN).| SYSTANE PF.| SYSTANE PF.| UNIQUEPH.| UNIQUEPH.