BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 7434943 · Received April 16, 2018

    Report

    Report Number
    2648035-2018-00531
    Event Type
    Malfunction
    Date Received
    April 16, 2018
    Date of Event
    March 19, 2018
    Report Date
    June 1, 2018
    Manufacturer
    JOHNSON AND JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474558281
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF IMPLANTED, GIVE DATE: NOT APPLICABLE NO PATIENT CONTACT REPORTED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE NO PATIENT CONTACT REPORTED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PRELOADED DELIVERY SYSTEM WAS RETURNED AT THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION UNDER THE MICROSCOPE SHOWED THAT THE CARTRIDGE TIP WAS DEFORMED. THE INTRAOCULAR LENS (IOL) WAS OBSERVED STUCK AT THE CARTRIDGE TUBE AND TIP. THE PUSH ROD TIP OVERRODE THE LENS AND PROTRUDED ALONG THROUGH THE SIDE OF THE CARTRIDGE TUBE/TIP, CREATING A CRACK. THE CUSTOMER'S REPORTED COMPLAINT WAS VERIFIED. HOWEVER, THE CONDITION OBSERVED WAS CONSISTENT WITH A UNIT THAT WAS HANDLED AND PREPARED FOR SURGICAL PROCESS. THERE IS NO EVIDENCE TO SUGGEST THAT THE COMPLAINT SAMPLE WAS AFFECTED BY THE MANUFACTURING PROCESS. NO PRODUCT DEFICIENCY WAS IDENTIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DIRECTIONS FOR USE (DFU) ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE WAS VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE CARTRIDGE WAS CRACKED. NO PATIENT CONTACT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276878 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON AND JOHNSON SURGICAL VISION, INC. PCB00 05050474558281

    Patients

    Seq Age Sex Outcome Treatment
    1