BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BVI B3PC

    MDR report key: 10837781 · Received November 13, 2020

    Report

    Report Number
    3006723646-2020-00019
    Event Type
    Injury
    Date Received
    November 13, 2020
    Date of Event
    October 28, 2020
    Report Date
    November 6, 2020
    Manufacturer
    HOYA SURGICAL OPTICS, INC.
    Product Code
    HQL
    UDI-DI
    00886158015772
    PMA / PMN Number
    P080004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP #1 EMDR IS BEING SUBMITTED TO FDA AS A REPORTABLE ADVERSE EVENT THAT OCCURRED IN THE USA. THE REPORT INCLUDES ADDITIONAL INFORMATION NOT AVAILABLE/INCLUDED IN THE INITIAL REPORT. PARTS OF THE PRODUCT WERE RETURNED TO THE MANUFACTURER, AND THE INVESTIGATION WAS CONDUCTED, WITH THE METHODS AND RESULTS AS NOTED BELOW. THE IOL WAS EJECTED OUT FROM THE INJECTOR. THE OPTIC WAS BROKEN FROM THE EDGE AT THE ROOT OF ONE HAPTIC AND BROKEN INTO TWO PIECES. THE INJECTOR WAS NOT RETURNED. NO ABNORMALITIES WERE FOUND IN PRODUCTION AND INSPECTION RECORDS OF THE PRODUCT. (SERIAL NO.: (B)(6); MODEL: B3PC) IN ADDITION, RESEARCH IN OUR COMPLAINT DATABASE INDICATED THERE WERE NOT ANY SIMILAR COMPLAINTS IN THE SAME PRODUCTION LOT. FROM OUR INVESTIGATION, WE BELIEVE THIS EVENT WAS NOT CAUSED BY OUR PRODUCT QUALITY. 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

    IOL GOT STUCK IN THE NOZZLE DURING INSERTION. USER ERROR AS TECH PRESSED SLIDER FORWARD SHE LIKELY DISPUTED BODY OF INJECTOR CAUSING LENS TO SPLIT IN HALF. SURGEON INSERTED SPLIT LENS, WIDENED INCISION AND REMOVED IOL WITH NO INJURY TO PATIENT. PATIENT IMPACT: INTRA-OPERATIVE EXPLANT INCREASED INCISION SIZE; PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY; INCREASED INCISION REQUIRED SUTURES TO CLOSE; PATIENT HEALTH NOT IMPACTED; PATIENT HAS RECOVERED AND IS FINE; NO PERMANENT OR NEGATIVE IMPACT ON PATIENT HEALTH EXPECTED.

    Additional Manufacturer Narrative · 1

    THIS INITIAL EMDR IS BEING SUBMITTED TO FDA AS A REPORTABLE ADVERSE EVENT THAT OCCURRED IN THE USA. MANUFACTURER'S CODES FOR: TYPE OF INVESTIGATION, FINDINGS, AND CONCLUSION ARE PENDING DEVICE RETURN AND COMPLETION OF PRODUCT INVESTIGATION. ONCE THE PRODUCT 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

    IOL GOT STUCK IN THE NOZZLE DURING INSERTION. USER ERROR AS TECH PRESSED SLIDER FORWARD SHE LIKELY DISPUTED BODY OF INJECTOR CAUSING LENS TO SPLIT IN HALF. SURGEON INSERTED SPLIT LENS, WIDENED INCISION AND REMOVED IOL WITH NO INJURY TO PATIENT. PATIENT IMPACT: INTRA-OPERATIVE EXPLANT INCREASED INCISION SIZE; PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY; INCREASED INCISION REQUIRED SUTURES TO CLOSE; PATIENT HEALTH NOT IMPACTED; PATIENT HAS RECOVERED AND IS FINE; NO PERMANENT OR NEGATIVE IMPACT ON PATIENT HEALTH EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1299501 BVI B3PC INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS, INC. BVI B3PC (+19.50 D) 00886158015772

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention