BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREVUE C

    MDR report key: 16509078 · Received March 8, 2023

    Report

    Report Number
    3006723646-2023-00035
    Event Type
    Injury
    Date Received
    March 8, 2023
    Date of Event
    February 8, 2023
    Report Date
    February 8, 2023
    Manufacturer
    HOYA SURGICAL OPTICS, INC.
    Product Code
    HQL
    UDI-DI
    10757770564146
    PMA / PMN Number
    P080004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 # 352650 (AND SUBSEQUENT TICKET # 359662). HOYA DUE DILIGENCE IS DOCUMENTED UNDER INTERNAL ISSUE-0807. THE REPORT INCLUDES CORRECTED INFORMATION AND ADDITIONAL INFORMATION NOT AVAILABLE/INCLUDED IN THE INITIAL REPORT. CORRECTED INFORMATION: D3 - CORRECTED ADDRESS; H3 - CORRECTED TO YES. ADDITIONAL INFORMATION: D9 - ADDED DATE OF RETURN; G1 - ADDED CONTACT INFO; 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. PORTIONS OF THE PRODUCT WERE RETURNED TO THE MANUFACTURER. THE INVESTIGATION WAS CONDUCTED, WITH THE METHODS AND RESULTS AS NOTED BELOW. ONLY IOL WAS AVAILABLE FOR INVESTIGATION. 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: PREVUE C). WE ALSO CONFIRMED THERE WERE NOT ANY ABNORMALITIES ON THE LOOP PULL STRENGTH TEST RECORD OF THE MATERIAL LOT. (SOTJ-G115-07) 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). 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 · 0

    BROKEN HAPTIC DURING USE TRAILING HAPTIC BROKE DURING INSERTION. THE LENS WAS REMOVED, AND A BACKUP LENS PLACED WITHOUT ISSUES. PATIENT IMPACT: INTRA-OPERATIVE EXPLANTATION. PATIENT HEALTH NOT IMPACTED.

    Description of Event or Problem · 0

    BROKEN HAPTIC DURING USE. TRAILING HAPTIC BROKE DURING INSERTION. THE LENS WAS REMOVED, AND A BACKUP LENS PLACED WITHOUT ISSUES. PATIENT IMPACT: INTRA-OPERATIVE EXPLANTATION. PATIENT HEALTH NOT IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496866 PREVUE C INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS, INC. PREVUE C (+19.50 D) 10757770564146

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention