BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PY-60AD

    MDR report key: 18419752 · Received December 29, 2023

    Report

    Report Number
    3006723646-2023-00469
    Event Type
    Injury
    Date Received
    December 29, 2023
    Date of Event
    November 27, 2023
    Report Date
    April 9, 2024
    Manufacturer
    HOYA SURGICAL OPTICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P080004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT # 1 EMDR IS BEING SUBMITTED TO FDA FOR A REPORTABLE EVENT THAT OCCURRED OUTSIDE THE USA. THE REPORT INCLUDES CORRECTED AND ADDITIONAL INFORMATION NOT AVAILABLE/INCLUDED IN THE INITIAL REPORT. CORRECTED INFORMATION: CORRECTED TO YES ADDITIONAL INFORMATION: TYPE OF REPORT - NOTED AS FOLLOW-UP #1 TYPE OF FOLLOW-UP - NOTED FOR CORRECTION AND ADDITIONAL INFORMATION ADDED CODES FOR MANUFACTURER'S INVESTIGATION: TYPE; FINDINGS; AND CONCLUSION. THE PRODUCT WAS RETURNED TO THE MANUFACTURER. THE INVESTIGATION WAS CONDUCTED, WITH THE METHODS AND RESULTS AS NOTED BELOW. APPEARANCE CHECK RESULT WAS CONSISTENT TO REPORTED INFORMATION. NO ABNORMALITIES WERE FOUND IN PRODUCTION AND INSPECTION RECORDS OF THE PRODUCT. SERIAL NO.: (B)(6) MODEL: PY-60AD. THE DYE TEST RESULT SHOWED THE INJECTOR TIP WAS PROPERLY COATED. THE LENS RELEASE TEST RESULT SHOWED THAT THE RE-INSTALLED NEW IOL COULD BE RELEASED OUT OF THE RETURNED CARTRIDGE/TIP WITHOUT ANY PROBLEMS. THE EXACT ROOT CAUSE WAS NOT DETERMINED. HOWEVER, BASED ON THE AVAILABLE INFORMATION AND OUR INVESTIGATION, WE BELIEVE THIS EVENT WAS NOT CAUSED BY OUR PRODUCT QUALITY. 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.

    Additional Manufacturer Narrative · 0

    THIS INITIAL EMDR IS BEING SUBMITTED TO FDA FOR A COMPLAINT THAT OCCURRED OUTSIDE THE USA FOR A LIKE PRODUCT REPORTING. CRACKED OR DEFORMED CARTRIDGE/TIP IS INDICATED AS A POTENTIAL MALFUNCTION RELATED TO THE IOL, AS COVERED UNDER THE WARNINGS SECTION OF THE PRODUCT'S INSTRUCTIONS FOR USE (IFU). REGARDING SECTION H6 - MANUFACTURER'S CODES FOR: TYPE OF INVESTIGATION, FINDINGS, AND CONCLUSION ARE PENDING 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 · 0

    EVENT OCCURRED IN CHINA CRACKED OR DEFORMED CARTRIDGE/TIP. CRACKED OR BROKEN OPTIC. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY. PRODUCT WAS EXPLANTED ON (B)(6) 2023 PRODUCT DEFECT CODE: A040101, FRACTURE.

    Description of Event or Problem · 0

    EVENT OCCURRED IN CHINA. CRACKED OR DEFORMED CARTRIDGE/TIP. CRACKED OR BROKEN OPTIC. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY. PRODUCT WAS EXPLANTED ON (B)(6) 2023. PRODUCT DEFECT CODE: A040101, FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1742033 PY-60AD INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS, INC. PY-60AD (+ 23 D)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other