BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 21665492 · Received March 21, 2025

    Report

    Report Number
    3012236936-2025-000079
    Event Type
    Malfunction
    Date Received
    March 21, 2025
    Date of Event
    February 26, 2025
    Report Date
    May 13, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    UDI-DI
    05050474726321
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THE SERIAL NUMBER (B)(6) WAS INCORRECT, AND THE CORRECT SERIAL NUMBER (B)(6) WAS PROVIDED. NO OTHER INFORMATION WAS PROVIDED. THE FOLLOWING FIELDS HAVE BEEN UPDATED ACCORDINGLY: SECTION D1: BRAND NAME: TECNIS SIMPLICITY IS REPLACED TO TECNIS IOL SECTION D2: D2A. COMMON DEVICE NAME: INTRAOCULAR LENS IS REPLACED TO LENS, INTRAOCULAR, TORIC OPTICS SECTION D2: D2B. DEVICE PRODUCT CODE: HQL IS REPLACED TO MJP SECTION D4: MODEL NUMBER: DIB00 WAS REPLACED TO DIU150 SECTION D4 - CATALOG NUMBER: DIB00I0235 WAS REPLACED TO DIU150I150 SECTION D4 - SERIAL NUMBER: (B)(6). SECTION D4 - EXPIRATION DATE: MAR 27, 2026 WAS REPLACED TO OCT 9, 2026. SECTION D4 - UDI NUMBER: (B)(4). SECTION H3: DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED SINCE THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE REPORTED ISSUE COULD NOT BE VERIFIED, AND PRODUCT QUALITY DEFICIENCY COULD NOT BE DETERMINED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH OF COMPLAINTS RELATED TO THIS PRODUCTION ORDER (PO) WAS PERFORMED. THE SEARCH REVEALED THAT ONE ADDITIONAL COMPLAINT WAS RECEIVED FOR THIS PO. NO ESCALATION REQUIRED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. SECTION H4: DEVICE MANUFACTURE DATE: MAR 27, 2023 WAS REPLACED TO OCT 9, 2023. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER THE IMPLANTATION OF PRELOADED INTRAOCULAR LENS, HAPTIC WAS BROKEN. CONSEQUENTLY, THE LENS WAS REMOVED AND REPLACED WITH THE NEW LENS. DIRECTIONS OF USE WERE FOLLOWED. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562571 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. DIU150 05050474726321

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown