BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 8516915 · Received April 16, 2019

    Report

    Report Number
    2648035-2019-00460
    Event Type
    Malfunction
    Date Received
    April 16, 2019
    Date of Event
    March 8, 2019
    Report Date
    November 11, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474558236
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVALUATION: YES, RETURNED TO MANUFACTURER ON: 4/9/2019. DEVICE RETURNED TO MANUFACTURER: YES. DEVICE EVALUATION: THE PRODUCT WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. THE PCB00 WAS RECEIVED WITH THE PLUNGER IN ADVANCED POSITION AND LOCK. THE PCB00 WAS OBSERVED AND UNDER MICROSCOPE AND NO VISCOELASTIC WERE OBSERVED INSIDE THE DEVICE. DFU STATES TO COMPLETELY FILL THE VIEWING WINDOW WITH OVD. THE LENS WAS OBSERVED STUCK BETWEEN THE CARTRIDGE TIP AND TUBE. THE PUSHROD WAS ADHERED TO THE STUCK LENS. THE DEVICE WAS OPENED; NO DEFECTS WERE OBSERVED IN THE UPPER BODY, LOWER BODY NEITHER IN THE PUSHROD. THE LENS COULD NOT BE REMOVED SINCE IT WAS STUCK TOO HARD. THE COMPLAINT WAS VERIFIED HOWEVER IT COULD BE RELATED TO THE LACK VISCOELASTIC USED THAT COULD CAUSE THE PUSHROD RESISTANCE DURING THE LENS DELIVERY AND THE LENS TO BE STUCK. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH ON COMPLAINTS RELATED TO THIS PRODUCTION ORDER WAS CONDUCTED IN THE COMPLAINT SYSTEM. THE SEARCH REVEALED THAT NO OTHER COMPLAINTS HAS BEEN RECEIVED FOR THIS PRODUCTION ORDER NUMBER. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & 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, GIVE DATE: NOT APPLICABLE, AS LENS WAS NOT IMPLANTED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS NOT IMPLANTED. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRELOADED INTRAOCULAR LENS GOT CAUGHT UP AND COULD NOT COME OUT OF THE NOSE CONE. THERE WAS PATIENT CONTACT WITH THE LENS. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES REQUIRED, NO PATIENT INJURY. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311063 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. PCB00 05050474558236

    Patients

    Seq Age Sex Outcome Treatment
    1