BEUDAMED
    FDA Adverse Event Injury Summary report: N

    255

    MDR report key: 16252887 · Received January 27, 2023

    Report

    Report Number
    3006723646-2023-00011
    Event Type
    Injury
    Date Received
    January 27, 2023
    Date of Event
    December 3, 2022
    Report Date
    December 28, 2022
    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
    Health Professional
    N

    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. CORRECTED INFORMATION: H3 - CORRECTED TO YES. ADDITIONAL INFORMATION: D9 - ADDED DATE RETURNED, G6 - TYPE OF REPORT - NOTED AS FOLLOW-UP #1, H2 - TYPE OF FOLLOW-UP - NOTED FOR CORRECTED INFORMATION AND ADDITIONAL INFORMATION H6 - 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. INJECTOR AND IOL WERE AVAILABLE FOR INVESTIGATION. NO ABNORMALITIES WERE FOUND IN PRODUCTION AND INSPECTION RECORDS OF THE PRODUCT. (SERIAL NO.: (B)(6); MODEL: 255). THE DYE TEST RESULT SHOWED THE INJECTOR TIP WAS PROPERLY COATED. PROPER COATING ALLOWS THE LENS TO ADVANCE. WE COULD RELEASE A RE-INSTALLED IOL FROM THE RETURNED INJECTOR WITHOUT ANY PROBLEMS. THE EXACT ROOT CAUSE OF THE EVENT WAS NOT DETERMINED. HOWEVER, BASED ON AVAILABLE INFORMATION, WE BELIEVE THIS EVENT WAS NOT CAUSED BY OUR PRODUCT QUALITY. CAPA-22-0009 HAS BEEN INITIATED FOR "DAMAGED HAPTIC" COMPLAINTS.

    Additional Manufacturer Narrative · 0

    THIS INITIAL REPORT IS BEING SUBMITTED TO FDA FOR A REPORTABLE EVENT THAT OCCURRED OUTSIDE THE USA. POSTERIOR CAPSULE RUPTURE IS INDICATED AS A POTENTIAL ADVERSE EVENT RELATED TO IOL IMPLANTATION, AS COVERED UNDER THE WARNINGS SECTION OF THE PRODUCT'S INSTRUCTIONS FOR USE (IFU). (B)(4). 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

    NO PRODUCT DEFECT. INTRA-OPERATIVE COMPLICATIONS THE POSTERIOR CAPSULE WAS RUPTURED AFTER IOL INSERTION.THE IOL WAS EXPLANTED FROM THE EYE, AND THE BACK UP IOL WAS IMPLANTED. THE PATIENT'S HEALTH IS NOT IMPACTED AS OF (B)(6) 2023.

    Description of Event or Problem · 0

    NO PRODUCT DEFECT. INTRA-OPERATIVE COMPLICATIONS. THE POSTERIOR CAPSULE WAS RUPTURED AFTER IOL INSERTION. THE IOL WAS EXPLANTED FROM THE EYE, AND THE BACK UP IOL WAS IMPLANTED. THE PATIENT'S HEALTH IS NOT IMPACTED AS OF ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616537 255 INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS, INC. 255 (+ 18.50 D)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention