BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 7392006 · Received April 3, 2018

    Report

    Report Number
    2648035-2018-00448
    Event Type
    Injury
    Date Received
    April 3, 2018
    Date of Event
    March 5, 2018
    Report Date
    April 3, 2018
    Manufacturer
    JOHNSON AND JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474558274
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT AND EXPLANT DATES: IF IMPLANTED OR EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE INTRAOCULAR LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. INITIAL REPORTER'S PHONE NUMBER: (B)(6). (B)(4). DEVICE EVALUATION: THE LENS WAS DISCARDED BY THE CUSTOMER. THEREFORE, THE REPORTED COMPLAINT WAS NOT VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DFU PROVIDE THE CUSTOMER WITH PROPER USAGE INSTRUCTIONS AND GUIDELINES. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT AN INTRAOCULAR LENS (IOL)/ PRELOADED DELIVERY SYSTEM HAD PLUNGER ROD ISSUES. THE SCRUB NURSE FOLLOWED THE PROCEDURE OF ADDING THE BALANCED SALT SOLUTION AND HEALON (VISCOELASTIC) TO THE INJECTOR. THE PLUNGER WAS ADVANCED AS PER PROTOCOL. WHEN THE SURGEON ENTERED THE EYE WITH THE INJECTOR, THE PLUNGER WOULD NOT TURN. HE TRIED TO ADVANCE THE PLUNGER THINKING THAT MAYBE IT HAD NOT BEEN ADVANCED FAR ENOUGH AND CLICKED INTO PLACE. THIS WAS UNSUCCESSFUL. HE THEN JUST PUSHED THE PLUNGER TO TRY AND INJECT THE IOL. IT ADVANCED WITH DIFFICULTY AND PUNCTURED THE CAPSULE WALL. SUBSEQUENTLY THE IOL NEEDED TO BE REMOVED. A NON-J&J IOL WAS USED AS A REPLACEMENT. THE VITRECTOR WAS SET UP BUT NOT USED. THE INCISION WAS INCREASED IN SIZE AND NEEDED TO BE SUTURED FOR CLOSURE. PATIENT LEFT THE OPERATING ROOM IN GOOD CONDITION. REPORTEDLY, THE DEVICE WAS DISCARDED BY THE CUSTOMER. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235071 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON AND JOHNSON SURGICAL VISION, INC. PCB00 05050474558274

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention