BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS 1-PIECE

    MDR report key: 7474750 · Received April 30, 2018

    Report

    Report Number
    2648035-2018-00631
    Event Type
    Malfunction
    Date Received
    April 30, 2018
    Date of Event
    March 5, 2018
    Report Date
    June 6, 2018
    Manufacturer
    JOHNSON AND JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474531697
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION, RETURNED TO MANUFACTURER ON: 05/04/2018. DEVICE EVALUATION: THE INTRAOCULAR LENS (IOL) WAS RETURNED AT THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION SHOWED THAT THE LENS WAS STUCK AT THE CARTRIDGE TIP. THE LENS WAS OBSERVED TORN AND THE CARTRIDGE TIP WAS CRACKED AND DEFORMED. THE CUSTOMER'S REPORTED COMPLAINT FOR LENS CRACKED UPON OPENING COULD NOT BE VERIFIED SINCE THE CONDITION OF THE RETURNED SAMPLE WAS CONSISTENT WITH A UNIT THAT WAS HANDLED AND PREPARED FOR SURGICAL PROCESS. BASED ON THE ANALYSIS THERE IS NO INDICATION OF PRODUCT QUALITY DEFICIENCY. 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) ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. THE DFU STATES TO EXAMINE THE LENS THOROUGHLY TO ENSURE PARTICLES HAVE NOT BECOME ATTACHED TO IT, AND EXAMINE THE LENS OPTICAL SURFACES FOR OTHER DEFECTS. 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 · 1

    IF IMPLANTED, GIVE DATE: NOT APPLICABLE NO PATIENT CONTACT WAS REPORTED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE NO PATIENT CONTACT WAS REPORTED. 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 INTRAOCULAR LENS (IOL) WAS NOTICED CRACKED WHEN THE LENS CASE WAS OPENED. NO PATIENT CONTACT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315575 TECNIS 1-PIECE MONOFOCAL IOLS HQL JOHNSON AND JOHNSON SURGICAL VISION, INC. ZCB00 05050474531697

    Patients

    Seq Age Sex Outcome Treatment
    1