BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PY-60AD

    MDR report key: 23885487 · Received December 23, 2025

    Report

    Report Number
    3006723646-2025-00087
    Event Type
    Injury
    Date Received
    December 23, 2025
    Date of Event
    November 7, 2025
    Report Date
    November 26, 2025
    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 INITIAL EMDR IS BEING SUBMITTED TO FDA FOR A REPORTABLE EVENT THAT OCCURRED OUTSIDE THE USA. HAPTIC DAMAGE IS INDICATED AS A POTENTIAL MALFUNCTION RELATED TO THE IOL, AS STATED 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.

    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: H3 - CORRECTED TO YES. H6 - UPDATED CODES FOR MANUFACTURER'S INVESTIGATION: TYPE; FINDINGS; AND CONCLUSION. ADDITIONAL INFORMATION: G6 - TYPE OF REPORT - NOTED AS FOLLOW-UP #1. H2 - TYPE OF FOLLOW-UP - NOTED FOR ADDITIONAL INFORMATION. THE PRODUCT WAS RETURNED TO THE MANUFACTURER. THE INVESTIGATION WAS CONDUCTED, WITH THE METHODS AND RESULTS AS NOTED BELOW. WE COULDN'T CONFIRM THE REPORTED EVENT BECAUSE THE IOL WAS NOT RETURNED. ADDITIONAL INFORMATION WAS REQUESTED, THE CUSTOMER CONFIRMED THAT BOTH THE LEADING AND TRAILING HAPTICS WERE RELATED TO THE REPORTED EVENT. HOWEVER, NO PICTURE AND SURGERY VIDEO WERE AVAILABLE. NO ABNORMALITIES WERE FOUND IN PRODUCTION AND INSPECTION RECORDS OF THE PRODUCT (SERIAL NO.: (B)(6); MODEL: PY-60AD). WE ALSO CONFIRMED THERE WERE NOT ANY ABNORMALITIES ON THE LOOP PULL STRENGTH TEST RECORD OF THE MATERIAL LOT (TYEA-60-03). 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.

    Description of Event or Problem · 0

    EVENT OCCURRED IN CHINA. DEFORMED HAPTIC AFTER IMPLANTATION. HAPTIC DOES NOT FOLD AS PER IFU THE HAPTIC FAILED TO UNFOLD 10 MINUTES AFTER IMPLANTATION. THE SURGEON IDENTIFIED IT AS A QUALITY ISSUE, REPLACED IT WITH A LENS OF THE SAME POWER, AND COMPLETED THE PROCEDURE SUCCESSFULLY. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY; PATIENT HEALTH NOT IMPACTED. IOL WAS EXPLANTED ON (B)(6) 2025. PROBLEM CODE: A040609 - MATERIAL TWISTED/BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616313 PY-60AD INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS, INC. PY-60AD (+ 23 D)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention