BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 22350264 · Received June 27, 2025

    Report

    Report Number
    3012236936-2025-000174
    Event Type
    Malfunction
    Date Received
    June 27, 2025
    Date of Event
    June 3, 2025
    Report Date
    June 27, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    UDI-DI
    05050474746565
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 AND COMPLAINT TRENDING WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H6: DEVICE CODE: 1069 - 1069 - BREAK - USED TO INDICATE LENS DAMAGE AND HAPTIC DAMAGE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRE-LOADED TORIC INTRAOCULAR LENS (IOL) MECHANISM DELIVERED LENS IN SUCH A WAY AS THERE WAS A INDENTATION DEFECT ON THE IOL OPTIC AND WAS CUT OUT AND REMOVED FROM PATIENTS LEFT EYE. BACK UP LENS WAS IMPLANTED. THERE WAS NO PATIENT INJURY. SURGERY WAS COMPLETED IN SAME PROCEDURE. DEVICE DID NOT WORK AS INTENDED OR DEVICE ISSUE DURING SET-UP/ PREP/ OR HANDLING. BSS WAS USED AS A LUBRICANT. NO DELIVERY ISSUES OR MANIPULATION WAS NOT REQUIRED TO DEPLOY THE DEVICE. ADDITIONAL INFORMATION RECEIVED STATED THAT THERE WAS A CENTRAL DEFECT THAT OCCURRED DURING DELIVERY OF THE PRE-LOADED IOL. IT LOOKED LIKE THE HAPTIC BENT A DIFFERENT WAY, SO WHEN THE PLUNGER WAS PRESSED FORWARD, IT COULD HAVE INDENTED THE LENS. IT¿S HARD TO SAY. THERE IS NO WAY TO SEE AN DEFECTS PRIOR TO IMPLANTATION. LENS OR HAPTIC WERE NOT STUCK IN CARTRIDGE. NO RESISTANCE FELT DURING DELIVERY; HOWEVER, IT WAS FOLDED WRONG. SOMETIMES IT¿S IMPOSSIBLE TO ¿HOLD ON TO THE PRODUCT¿ AS THIS LENS WAS CUT INTO PIECES TO BE REMOVED. THERE WERE NO COMPLICATIONS, AND THE BACK-UP LENS WENT IN BEAUTIFULLY. NO PATIENT INJURY AND ANY OTHER INTERVENTION WAS NOT REQUIRED. THERE WAS NO USE ERROR. THE PRODUCT WAS DESTROYED AND WILL NOT BE SHIPPED BACK. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1127684 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. DIU150 05050474746565

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female