BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 7482176 · Received May 3, 2018

    Report

    Report Number
    2648035-2018-00646
    Event Type
    Malfunction
    Date Received
    May 3, 2018
    Date of Event
    April 5, 2018
    Report Date
    July 3, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474558212
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 05/9/2018. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: THE PRODUCT WAS RECEIVED INSIDE A PLASTIC BAG. THE REPORTED FOREIGN MATERIAL AS A BLUE FLECK WAS RECEIVED SEALED ON A GAUZE IN A SPECIMEN CONTAINER. THE FOREIGN MATERIAL (BLUE FLECK) WAS SENT TO EVANS ANALYTICAL GROUP LABORATORIES (EAG) FOR FURTHER ANALYSIS. EAG EVALUATION: BASED ON THE EAG LABORATORIES RESULTS AND THE SUBJECT MATTER EXPERT (SME) EVALUATION, THE FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS INDICATES THAT THE FOREIGN MATERIAL IS CONSISTENT WITH POLYPROPYLENE. THE MANUFACTURING DATA CONFIRMS NO PROCESS DEVIATIONS THAT MAY LEAD TO VISIBLE DEBRIS/PARTICLE DEPOSITION ON THE IOL THAT MAY BE UNDETECTED BY CONTROL PROCESS. THE MANUFACTURING CONTROLS SHOULD BE CAPABLE TO IDENTIFY THE PRESENCE OF THIS TYPE OF PARTICULATE OR SUBSTANCE DURING THE INSPECTION CONTROLS DEFINED AS PART OF THE MANUFACTURING PROCESS. BASED ON THE EVALUATION, THE REPORTED ISSUE WAS VERIFIED; HOWEVER, IT IS NOT POSSIBLE TO CONFIRM IF THE PARTICLE OBSERVED IS RELATED TO MANUFACTURING PROCESS AS THE REPORTED DEVICE IS OPENED AND HANDLED. MANUFACTURING RECORD REVIEW OF THE PRODUCTION ORDER AND RELATED DOCUMENT REVEALED THAT THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. THERE WAS NO DISCREPANCY FOUND DURING THE REVIEW. A SEARCH REVEALED THAT NO OTHER COMPLAINT WAS RECEIVED FROM THIS PRODUCTION ORDER. 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

    IF EXPLANTED; GIVE DATE: NOT APPLICABLE (N/A). THE LENS REMAINS IMPLANTED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT A FOREIGN MATERIAL WAS FOUND ON A PCB00 INTRAOCULAR LENS (IOL) AFTER INSERTION INTO THE PATIENT¿S LEFT EYE. FURTHER INFORMATION WAS PROVIDED THAT THE PHYSICIAN INSERTED THE LENS AND WHEN IT UNFOLDED INSIDE THE EYE, HE NOTICED A BLUE SPECK ON THE LENS SURFACE. THE PHYSICIAN SAFELY REMOVED THE SPECK FROM THE LENS SURFACE AND THE LENS REMAINS IMPLANTED. THERE WAS NO PATIENT INJURY AND THE PATIENT IS REPORTED TO BE DOING FINE. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326443 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. PCB00 05050474558212

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR