BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 9083850 · Received September 18, 2019

    Report

    Report Number
    2648035-2019-01015
    Event Type
    Malfunction
    Date Received
    September 18, 2019
    Report Date
    November 10, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474558274
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVALUATION: YES, RETURNED TO MANUFACTURER ON 9/16/2019. DEVICE RETURNED TO MANUFACTURER: YES. DEVICE EVALUATION: THE RETURNED PCB00 DEVICE WAS RECEIVED IN A PLASTIC BAG. THE PLUNGER WAS ADVANCED FOR DELIVERY AND FOUND LOCKED AND FUNCTIONAL. THE PCB00 DEVICE WAS OBSERVED UNDER MICROSCOPE AND TRACES OF VISCOELASTIC AND/OR BALANCED SALT SOLUTION WERE OBSERVED ONLY AT THE CARTRIDGE TIP. THE DIRECTIONS FOR USE INCLUDES THE FOLLOWING: COMPLETELY FILL THE VIEWING WINDOW WITH OPHTHALMIC VISCOSURGICAL DEVICE (OVD). THE LENS IS STUCK AND TORN AT THE CARTRIDGE TIP; THE REPORTED ISSUE WAS VERIFIED. THE CARTRIDGE IS DEFORMED AND CRACKED. THERE WERE NO DAMAGES OBSERVED ON THE ASSEMBLY; THERE IS NO VISIBLE GAP. THE ASSEMBLY OF THE DEVICE RETURNED WAS FOUND CORRECT FOR THE PUSHROD ORIENTATION PRELOADED ASSEMBLY INSTRUCTIONS. BASED ON THE PRODUCT RETURNED EVALUATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED NO ADDITIONAL INVESTIGATION REQUEST (IR) FOR THIS PRODUCTION ORDER NUMBER HAS BEEN RECEIVED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE (B)(4) AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    IF IMPLANTED, IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS STUCK IN INSERTER. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION WAS PROVIDED STATING THAT THE TIP OF THE CARTRIDGE AND THE LEADING HAPTIC WERE IN CONTACT WITH PATIENT'S EYE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACK UP LENS. THERE WAS NO INCISION ENLARGEMENT, NO SUTURE AND NO VITRECTOMY. NO OTHER MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED AND THE PATIENT WAS DOING WELL AT THE TIME OF DISCHARGE. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877847 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. PCB00 05050474558274

    Patients

    Seq Age Sex Outcome Treatment
    1