BEUDAMED
    FDA Adverse Event Injury Summary report: N

    B1PC

    MDR report key: 16509123 · Received March 8, 2023

    Report

    Report Number
    3006723646-2023-00037
    Event Type
    Injury
    Date Received
    March 8, 2023
    Date of Event
    February 7, 2023
    Report Date
    February 12, 2023
    Manufacturer
    HOYA SURGICAL OPTICS, INC.
    Product Code
    HQL
    UDI-DI
    00886158017141
    PMA / PMN Number
    P080004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 IN THE USA. NOTE: DELAYED EMDR SUBMISSION WAS DUE TO FDA ESG WEBTRADER ACCOUNT SYSTEM SOFTWARE ISSUES, PER FDA ESG HELP DESK TICKET # (B)(4) (AND SUBSEQUENT TICKET # (B)(4)). HOYA DUE DILIGENCE IS DOCUMENTED UNDER INTERNAL (B)(4). THE REPORT INCLUDES CORRECTED INFORMATION AND ADDITIONAL INFORMATION NOT AVAILABLE/INCLUDED IN THE INITIAL REPORT. ADDITIONAL INFORMATION: G6 - TYPE OF REPORT - NOTED AS FOLLOW-UP #1. H2 - TYPE OF FOLLOW-UP - NOTED FOR CORRECTED INFORMATION AND ADDITIONAL INFORMATION. H3 - INDICATED DEVICE NOT RETURNED. H6 - ADDED CODES FOR MANUFACTURER'S INVESTIGATION: TYPE; FINDINGS; AND CONCLUSION. THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER. THE INVESTIGATION WAS CONDUCTED, WITH THE METHODS AND RESULTS AS NOTED BELOW. NO ABNORMALITIES WERE FOUND IN PRODUCTION AND INSPECTION RECORDS OF THE PRODUCT. (SERIAL NO.: (B)(6); MODEL: B1PC). WE ALSO CONFIRMED THERE WERE NOT ANY ABNORMALITIES ON THE LOOP PULL STRENGTH TEST RECORD OF THE MATERIAL LOT. (SOUM-G115-15). 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 EMDR IS BEING SUBMITTED TO FDA AS A REPORTABLE EVENT THAT OCCURRED IN THE USA. HAPTIC DAMAGE IS INDICATED AS A POTENTIAL MALFUNCTION RELATED TO THE IOL, AS COVERED UNDER THE WARNINGS SECTION OF THE PRODUCT'S INSTRUCTIONS FOR USE (IFU). MANUFACTURERS 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 · 0

    DAMAGED HAPTIC AFTER IMPLANTATION. DOCTOR IMPLANTED NOTICE BROKEN TRAILING HAPTIC AND HAD TO EXPLANT LENS. PATIENT HEALTH NOT IMPACTED; PATIENT HAS RECOVERED AND IS FINE.

    Description of Event or Problem · 0

    DAMAGED HAPTIC AFTER IMPLANTATION. DOCTOR IMPLANTED NOTICE BROKEN TRAILING HAPTIC AND HAD TO EXPLANT LENS. PATIENT HEALTH NOT IMPACTED; PATIENT HAS RECOVERED AND IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708904 B1PC INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS, INC. B1PC (+17.00 D) 00886158017141

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention