BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOYA 255

    MDR report key: 12351567 · Received August 20, 2021

    Report

    Report Number
    3006723646-2021-00066
    Event Type
    Injury
    Date Received
    August 20, 2021
    Date of Event
    July 15, 2021
    Report Date
    July 26, 2021
    Manufacturer
    HOYA SURGICAL OPTICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P080004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP #1 EMDR IS BEING SUBMITTED TO FDA FOR A REPORTABLE EVENT THAT OCCURRED OUTSIDE OF THE USA. THE REPORT INCLUDES CORRECTED INFORMATION AND ADDITIONAL INFORMATION NOT AVAILABLE/INCLUDED IN THE INITIAL REPORT. H10 - NOTE: "ENDOPHTHALMITIS" IS INDICATED AS A POTENTIAL ADVERSE EVENT RELATED TO IOL IMPLANTATION IN HOYA IFU COVERED UNDER THE WARNINGS SECTION. THE INVESTIGATION WAS CONDUCTED, WITH THE METHODS AND RESULTS AS NOTED BELOW. THE EXPLANTED LENS WAS WRAPPED IN GAUZE AND RETURNED TO THE MANUFACTURER. BIOLOGIC MATERIAL (I.E., BLOOD AND OCULAR FLUID), AND NON-BIOLOGIC MATERIAL (I.E., GAUZE FIBERS) WERE FOUND ON THE LENS. NO MATTER/MATERIAL WHICH MIGHT CAUSE STERILE ENDOPHTHALMITIS (E.G., METAL) WAS DETECTED. NO ABNORMALITIES WERE FOUND IN PRODUCTION AND INSPECTION RECORDS OF THE PRODUCT. (SERIAL NO.: (B)(6); MODEL: 255). THERE WERE NOT ANY ABNORMALITIES ON THE STERILIZATION RECORDS OF THE LOT (TL012). A COMPLETED POST-OPERATIVE INFLAMMATION SUMMARY (POIS) FORM WAS RECEIVED FROM THE CLINICIAN AND REVIEWED BY THE EXPERT REVIEWER AND THE MEDICAL MONITOR. THEIR CONCLUSIONS ARE NOTED BELOW: THE EXPERT REVIEWER ASSESSED THE POIS AND REPORTED HER CONCLUSION AS ENDOTOXIN-INDUCED INFLAMMATION. HOWEVER, SHE NOTED THAT THE MANUFACTURING LOT THE LENS CAME FROM HAS MET THE ENDOTOXIN ACCEPTANCE LIMIT, AND ENDOTOXIN CAN COME FROM OTHER SOURCES INCLUDING ANYTHING THAT WAS USED DURING SURGERY INCLUDING THE SURGICAL ADJUNCTS AND ACCESSORIES. THE MEDICAL MONITOR AGREED TO THE EXPERT REVIEWER'S ASSESSMENT AND CONCLUSION. HOWEVER, HE ALSO INDICATED THE POSSIBILITY OF INFECTIOUS ENDOPHTHALMITIS. A REVIEW OF THE MOST RECENT COMPLAINT TRENDING DATA INDICATES THAT NO SIGNIFICANT TRENDS HAVE BEEN IDENTIFIED AT THIS TIME AND NO CAPA IS REQUIRED AS PART OF THE PRODUCT EVALUATION.

    Description of Event or Problem · 0

    THE IOL WAS IMPLANTED ON (B)(6) 2021. THE INFLAMMATION WAS OBSERVED ON (B)(6) 2021. THE IOL WAS EXPLANTED FROM THE PATIENT EYE ON (B)(6) 2021. POST-OPERATIVE INFLAMMATION SUMMARY (POIS) FORM COMPLETED BY THE CLINICIAN INDICATED THE FOLLOWING: HISTORY OF PERIOPERATIVE EXAMINATIONS, MEDICATIONS AND SYMPTOM COURSE (B)(6) 2021: VEGAMOX DROP AND TARIVID OINTMENT WERE PRESCRIBED FOR 4 DAYS. (B)(6) 2021: THE PATIENT WAS IMPLANTED WITH MODEL 255 INTO THE LEFT EYE. THE INCISION WAS SUTURED WITH 10-0 THREAD. DROPS OF ANTIBIOTICS, STEROID, NON-STEROID WERE PRESCRIBED. (B)(6) 2021: THE DOCTOR DIAGNOSED THE INFLAMMATION AS AN ENDOPHTHALMITIS. VEGAMOX (ONCE AN HOUR), 0.1% SANBETASON (5 TIMES A DAY), BRONUK (TWICE A DAY) WERE PRESCRIBED. (B)(6) 2021: VEGAMOX (ONCE TWO HOURS), 0.1% SANBETASON (5 TIMES A DAY), BRONUK (TWICE A DAY) WERE PRESCRIBED. (B)(6) 2021: VEGAMOX (ONCE THREE HOURS), 0.1% SANBETASON (5 TIMES A DAY), BRONUK (TWICE A DAY) WERE PRESCRIBED. (B)(6) 2021: VEGAMOX (5 TIMES A DAY), 5% SODIUM CHRORIDE (4 TIMES A DAY), 0.1% SANBETASON (5 TIMES A DAY), BRONUK (TWICE A DAY) WERE PRESCRIBED. (B)(6) 2021: THE PATIENT INTRODUCED TO THE OTHER HOSPITAL. VITRECTOMY AND INTRAVITREAL INJECTION OF VANCOMYCIN AND CEFTAZIDIME WERE PERFORMED. THE IOL WAS EXPLANTED FROM THE EYE. NOT SPECIFIED: THE VISUAL ACUITY WAS RECOVERED TO 0.9.

    Additional Manufacturer Narrative · 1

    THIS INITIAL EMDR IS BEING SUBMITTED TO FDA FOR OUTSIDE US LIKE PRODUCTS REPORTING. MANUFACTURER'S CODES FOR: TYPE OF INVESTIGATION, FINDINGS, AND CONCLUSION ARE PENDING COMPLETION OF PRODUCT COMPLAINT INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED TO FDA WHICH WILL INCLUDE THE MANUFACTURER'S CODES FOR TYPE OF INVESTIGATION, FINDINGS, AND CONCLUSION.

    Description of Event or Problem · 1

    THE IOL WAS IMPLANTED ON (B)(6) 2021. THE INFLAMMATION WAS OBSERVED ON (B)(6) 2021. THE IOL WAS EXPLANTED FROM THE PATIENT EYE ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1245645 HOYA 255 INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS, INC. HOYA 255 (+15.00 D)

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention