BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOYA ISERT 150

    MDR report key: 12194156 · Received July 19, 2021

    Report

    Report Number
    3006723646-2021-00055
    Event Type
    Injury
    Date Received
    July 19, 2021
    Date of Event
    May 20, 2021
    Report Date
    June 22, 2021
    Manufacturer
    HOYA SURGICAL OPTICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P080004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP #2 EMDR IS BEING SUBMITTED TO FDA FOR A REPORTABLE EVENT THAT OCCURRED OUTSIDE OF THE USA. THE REPORT INCLUDES ADDITIONAL INFORMATION NOT AVAILABLE/INCLUDED IN THE INITIAL REPORT AND FOLLOW-UP #1 REPORTS ADDITIONAL INFORMATION: G6 - TYPE OF REPORT - NOTED AS FOLLOW-UP #2. H2 - TYPE OF FOLLOW-UP - NOTED FOR ADDITIONAL INFORMATION. H6 - ADDED CODES FOR ADDITIONAL PATIENT HEALTH EFFECT IMPACT. A COMPLETED POST-OPERATIVE INFLAMMATION SUMMARY (POIS) FORM WAS RECEIVED FROM THE CLINICIAN ON 26-AUG-2021. FOR COMPLAINT(B)(4) (PL) - SN: (B)(6). POIS INDICATED THE FOLLOWING INFORMATION REGARDING PATIENT OUTCOMES RECEIVED TO-DATE: TREATMENT: VITREOUS TAP; AEROBIC CULTURE; AND ANAEROBIC CULTURE. CULTURE RESULTS: NEGATIVE. FOLLOW-UP PLAN: VANCOMYCIN, PPV - PARS PLANA VITRECTOMY, SILICONE OIL.

    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 ADDITIONAL INFORMATION NOT AVAILABLE/INCLUDED IN THE INITIAL REPORT. THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER. THE INVESTIGATION WAS CONDUCTED, WITH THE METHODS AND RESULTS AS NOTED BELOW. THE PRODUCT HAS NOT BEEN RETURNED AND THE POST-OPERATIVE INFLAMMATION SUMMARY (POIS) FORM HAS NOT PROVIDED AS OF (B)(6) 2021. NO ABNORMALITIES WERE FOUND IN PRODUCTION AND INSPECTION RECORDS OF THE PRODUCT. (SERIAL NO.: (B)(6); MODEL: 150). IN ADDITION, NO ABNORMALITIES WERE FOUND ON THE STERILIZATION RECORD FOR THE LOT. (EP304) SINCE THERE WERE NO ABNORMALITIES IN STERILIZATION RECORD ESPECIALLY RESIDUAL EO TEST RESULT, BIOLOGICAL INDICATOR TEST RESULT AND ENDOTOXIN TEST, WE ASSURE THESE BATCHES WERE STERILIZED APPROPRIATELY. IN ADDITION, WE RESEARCHED IN OUR COMPLAINT DATABASE BUT THERE WERE NOT ANY INFLAMMATION COMPLAINTS REPORTED WITH THE PRODUCTS BELONG TO SAME PRODUCTION LOT NUMBERS AND STERILIZATION LOT NUMBERS. THEREFORE, IN OUR OPINION, THIS CASE WOULD NOT BE PRODUCT RELATED BASED ON CURRENT AVAILABLE INFORMATION. RISK ANALYSIS WAS CONDUCTED ON THE PRODUCT LINE AND FAILURE CODE IS NOTED BELOW. 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

    BACTERIAL ENDOPHTHALMITIS; THE PATIENT HAS DEVELOPED A PROBLEM WITH ENDOPHTHALMITIS AFTER SURGERY. THE PATIENT REQUIRED AN IMMEDIATE INTRAVITREAL INJECTION OF ANTIBIOTICS. IT CANNOT BE CLEARLY STATED THAT THE LENS WAS THE CAUSE OF ENDOPHTHALMITIS. THE SURGEON SAYS HE HAS NOT CHANGED ANYTHING IN THE SURGICAL PROCEDURE AND HAS BEEN USING THE SAME PRODUCTS FOR YEARS. IOL REMAINED IN THE EYE.

    Description of Event or Problem · 0

    BACTERIAL ENDOPTHALMITIS; THE PATIENT HAS DEVELOPED A PROBLEM WITH ENDOPHTHALMITIS AFTER SURGERY. THE PATIENT REQUIRED AN IMMEDIATE INTRAVITREAL INJECTION OF ANTIBIOTICS. IT CANNOT BE CLEARLY STATED THAT THE LENS WAS THE CAUSE OF ENDOPHTHALMITIS. THE SURGEON SAYS HE HAS NOT CHANGED ANYTHING IN THE SURGICAL PROCEDURE AND HAS BEEN USING THE SAME PRODUCTS FOR YEARS. IOL REMAINED IN THE EYE.

    Additional Manufacturer Narrative · 1

    THIS INITIAL EMDR IS BEING SUBMITTED TO FDA FOR OUTSIDE US LIKE PRODUCTS REPORTING. "ENDOPHTHALMITIS" IS INDICATED AS A POTENTIAL ADVERSE EVENT RELATED TO IOL IMPLANTATION IN HOYA IFU COVERED UNDER THE WARNINGS SECTION. (B)(4). MANUFACTURER'S CODES FOR INVESTIGATION TYPE, FINDINGS AND CONCLUSION ARE PENDING THE COMPLETION OF THE PRODUCT INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED TO FDA WHICH WILL INCLUDE THE MANUFACTURER'S CODES FOR INVESTIGATION TYPE, FINDINGS AND CONCLUSION.

    Description of Event or Problem · 1

    BACTERIAL ENDOPHTHALMITIS; THE PATIENT HAS DEVELOPED A PROBLEM WITH ENDOPHTHALMITIS AFTER SURGERY. THE PATIENT REQUIRED AN IMMEDIATE INTRAVITREAL INJECTION OF ANTIBIOTICS. IT CANNOT BE CLEARLY STATED THAT THE LENS WAS THE CAUSE OF ENDOPHTHALMITIS. THE SURGEON SAYS HE HAS NOT CHANGED ANYTHING IN THE SURGICAL PROCEDURE AND HAS BEEN USING THE SAME PRODUCTS FOR YEARS. IOL REMAINED IN THE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1086774 HOYA ISERT 150 INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS, INC. HOYA 150 (+24.50 D)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention