BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS EYHANCE OB SIMPLICITY

    MDR report key: 21965147 · Received May 5, 2025

    Report

    Report Number
    3012236936-2025-000125
    Event Type
    Injury
    Date Received
    May 5, 2025
    Report Date
    May 5, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS A3, A4 AND A5: INFORMATION UNKNOWN/NOT PROVIDED. SECTION B3 - DATE OF EVENT: EXACT DATE NOT PROVIDED. ARTICLE ACCEPTANCE DATE IS 14 MAY 2024. SECTION D4 - CATALOG NUMBER: A COMPLETE NUMBER IS UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D4 - SERIAL NUMBER: UNKNOWN/NOT PROVIDED. SECTION D4 - EXPIRATION DATE: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D4 - UDI NUMBER: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A - IMPLANT DATE: INFORMATION UNKNOWN/NOT PROVIDED. SECTION D6B - EXPLANT DATE: INFORMATION UNKNOWN/NOT PROVIDED. SECTION G4 - PMA/510(K) NUMBER: THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS OPTIBLUE SIMPLICITY PRELOADED 1-PIECE IOL, MODEL DIB00V THAT HAS A SIMILAR DEVICE, TECNIS SIMPLICITY PRELOADED 1-PIECE IOL MODEL DIB00 WHICH IS DISTRIBUTED IN THE UNITES STATES UNDER PMA P980040. SECTION H3: THE INTRAOCULAR LENS WAS NOT RETURNED FOR ANALYSIS. THE SERIAL NUMBER FOR THIS DEVICE IS NOT AVAILABLE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4 - DEVICE MANUFACTURE DATE: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. CITATION: NOGUCHI, S.; NAKAKURA, S.; TABUCHI, H.; NOGUCHI, A. DIRECT INTRAOCULAR LENS EXTRACTION USING A NEWLY DEVELOPED LENS-GRABBING FORCEPS. J. CLIN. MED. 2024, 13, 2938. HTTPS://DOI.ORG/10.3390/ JCM13102938. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: DIRECT INTRAOCULAR LENS EXTRACTION USING A NEWLY DEVELOPED LENS-GRABBING FORCEPS. A STUDY WAS DONE TO REPORT THE RESULTS OF A NOVEL TECHNIQUE FOR IOL EXPLANTATION THROUGH A SMALL INCISION USING A SPECIALLY-DESIGNED FORCEPS. THE CLINICAL RESULTS FOR THE TECHNIQUE WERE REPORTED FOR 10 CASES WITH DIFFERENT IOLS IMPLANTED. AMONG THE 10 EYES THAT UNDERWENT IOL EXPLANT, 6 WERE PREVIOUSLY IMPLANTED WITH THE FOLLOWING J&J DEVICES: ZLB00 (N=1), ZCB00 (N=1), ZXR00V (N=1), DIB00V (N=3). THE CAUSE FOR THE EXPLANT WAS NOT IDENTIFIED BY THE AUTHORS. NOTE THAT THIS ARTICLE ALSO DISCUSSED MULTIFOCAL IOLS (ZLB00, ZXR00V, ZLB00) WHICH ARE OUT OF SCOPE OF THE CURRENT LITERATURE REVIEW (MONOFOCALS). A COPY OF THE ARTICLE IS ATTACHED TO THIS REPORT. NOTE: A SEPARATE REPORT WILL BE SUBMITTED FOR EACH REPORTED PATIENT. THIS REPORT IS FOR THE RIGHT EYE OF THE 56 YEAR OLD PATIENT. THE LEFT EYE OF THE 56 YEAR OLD PATIENT WAS SUBMITTED UNDER MFR REPORT NUMBER 3012236936-2025-0001250.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1833460 TECNIS EYHANCE OB SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00V

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Unknown Required Intervention