BEUDAMED
    FDA Adverse Event Injury Summary report: N

    255

    MDR report key: 16252917 · Received January 27, 2023

    Report

    Report Number
    3006723646-2023-00014
    Event Type
    Injury
    Date Received
    January 27, 2023
    Date of Event
    December 20, 2022
    Report Date
    December 28, 2022
    Manufacturer
    .
    Product Code
    HQL
    PMA / PMN Number
    P080004
    Adverse Event
    Yes
    Product Problem
    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. PORTIONS OF THE PRODUCT WERE RETURNED TO THE MANUFACTURER. THE INVESTIGATION WAS CONDUCTED, WITH THE METHODS AND RESULTS AS NOTED BELOW. A TIP OF BROKEN TRAILING HAPTIC WAS RETURNED WITH THE INJECTOR EJECTED. APPEARANCE CHECK RESULT WAS CONSISTENT TO REPORTED INFORMATION. NO ABNORMALITIES WERE FOUND IN PRODUCTION AND INSPECTION RECORDS OF THE PRODUCT. (SERIAL NO.: TDM81699; MODEL: 255). 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. 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). 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 THE DOCTOR NOTICED THE TRAILING HAPTIC WAS SEPARATED AT TIP. THE DOCTOR REMOVED THE HAPTIC PIECE FROM THE EYE. PATIENT IMPACT: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS.

    Description of Event or Problem · 0

    DAMAGED HAPTIC AFTER IMPLANTATION. THE DOCTOR NOTICED THE TRAILING HAPTIC WAS SEPARATED AT TIP. THE DOCTOR REMOVED THE HAPTIC PIECE FROM THE EYE. PATIENT IMPACT: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411497 255 INTRAOCULAR LENS HQL . 255 (+ 21.50 D)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention