BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS

    MDR report key: 7387097 · Received March 30, 2018

    Report

    Report Number
    2648035-2018-00436
    Event Type
    Malfunction
    Date Received
    March 30, 2018
    Date of Event
    February 7, 2018
    Report Date
    May 25, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION; RETURNED TO MANUFACTURER ON: 04/05/2018. DEVICE EVALUATION: THE DEBRIS/PARTICLE WAS RECEIVED IN A PLASTIC CONTAINER. SAMPLE WAS SENT TO THE LAB FOR FURTHER ANALYSIS. THE FTIR ANALYSIS INDICATES THAT THE FIBER-LIKE FOREIGN MATERIAL IS CONSISTENT WITH A CELLULOSIC MATERIAL (E.G. COTTON, RAYON, LINT). THIS IS A COMMON MATERIAL USED IN PROTECTIVE CLOTHING OF PRODUCTION OPERATORS. THROUGHOUT THE MANUFACTURING PROCESSES, THERE ARE VARIOUS CLEANING OPERATIONS AND 100% VISUAL INSPECTION UTILIZING MICROSCOPE MAGNIFICATION STEPS THAT WOULD HAVE IDENTIFIED AND DISCARDED A LENS WITH SIMILAR PARTICULATE, AS REQUIRED BY OUR APPROVED PROCEDURES. THE MANUFACTURING PROCESS IS PERFORMED INSIDE A REGULATED CLEAN ROOM THAT REQUIRES FULL GOWNING BEFORE ENTERING THE ROOM. THE MANUFACTURING CONTROLS ARE CAPABLE OF IDENTIFYING THE PRESENCE OF THIS TYPE OF PARTICULATE DURING THE INSPECTION CONTROLS, AS DEFINED PART OF THE MANUFACTURING PROCESS. THE REPORTED COMPLAINT WAS VERIFIED; HOWEVER, IT CANNOT BE FULLY CONFIRM IF THIS ISSUE OCCUR DURING THE MANUFACTURING PROCESS, SINCE THE LENS USED WAS OPENED AT THE SURGERY SITE. BASED ON THE INVESTIGATION RESULTS, THERE IS NO INDICATION OF PRODUCT QUALITY DEFICIENCY. MANUFACTURING RECORD REVIEW: MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED SINCE THE SERIAL NUMBER IS UNKNOWN. 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: BASED ON THE INVESTIGATION RESULTS, 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 · 1

    (B)(6). LENS REMOVED AND REPLACED IN INITIAL PROCEDURE. LENS REMOVED AND REPLACED IN INITIAL PROCEDURE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FOREIGN MATERIAL WAS FOUND IN THE EYE DURING IMPLANTATION. FOREIGN MATERIAL WAS REMOVED SUCCESSFULLY WITH NO PATIENT COMPLICATION. THE INTRAOCULAR LENS (IOL) PRODUCT WAS DISCARDED. THERE WAS NO PATIENT INJURY AND NO ENLARGEMENT OF WOUND. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227990 TECNIS MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. PCB00

    Patients

    Seq Age Sex Outcome Treatment
    1