BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS CL

    MDR report key: 7647978 · Received June 28, 2018

    Report

    Report Number
    2648035-2018-00920
    Event Type
    Malfunction
    Date Received
    June 28, 2018
    Date of Event
    May 8, 2018
    Report Date
    September 4, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474530737
    PMA / PMN Number
    P880081
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION, RETURNED TO MANUFACTURER ON: 7/17/2018. DEVICE EVALUATION: THE REPORTED LENS RETURNED IN ITS ORIGINAL LENS/INSERT CASE. VISUAL INSPECTION USING MAGNIFICATION WAS PERFORMED: THE LENS RETURNED CUT IN TWO PIECES. A SMALL WHITE PARTICLE WAS OBSERVED ON THE LENS SURFACE IN ONE OF THE TWO LENS PIECES RETURNED. THE REPORTED ISSUE WAS VERIFIED. HOWEVER, THERE IS NO EVIDENCE TO SUGGEST THAT THE COMPLAINT SAMPLE HAS BEEN AFFECTED BY THE MANUFACTURING PROCESS SINCE THE UNIT WAS HANDLED AND PREPARED FOR SURGICAL USE. NO PRODUCT DEFICIENCY WAS IDENTIFIED. SUBJECT MATTER EXPERT (SME) EVALUATION: THE FOREIGN MATERIAL WAS SUBMITTED TO EVAN ANALYTICAL GROUP (EAG) LABORATORIES FOR COMPOSITION IDENTIFICATION THROUGH FTIR (FOURIER TRANSFORM INFRARED SPECTROSCOPY). FTIR ANALYSIS SHOWS A LIGHT PARTICLE ON THE IOL SURFACE THAT IS CONSISTENT WITH AN POLYURETHANE SPECIES. HOWEVER, BASED ON THE EVIDENCE OBSERVED, IT IS NOT POSSIBLE TO CONFIRM IF THE PARTICLE OR SUBSTANCE IS RELATED TO MANUFACTURING AS THE REPORTED LENS WAS HANDLED AND PREPARED FOR SURGICAL USE. MANUFACTURING RECORD REVIEW: THE MANUFACTURING PROCESS RECORD WAS EVALUATED AND NO DEVIATION WAS FOUND DURING PROCESS RELATED TO THE COMPLAINT ISSUE REPORTED. THERE WAS NO DISCREPANCY FOUND DURING THE MRR (MANUFACTURING RECORD REVIEW). THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO OTHER INVESTIGATION REQUEST HAS BEEN RECEIVED FOR 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: 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 · 1

    IF IMPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE INTRAOCULAR LENS WAS NOT IMPLANTED. IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE INTRAOCULAR LENS WAS NOT IMPLANTED. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEBRIS PRESENTED ON Z9002 INTRAOCULAR LENS (IOL) WHEN INSERTING LENS. THERE WAS NO PATIENT INJURY REPORTED AND NO SURGICAL INTERVENTION WAS REQUIRED. PRODUCT IS EXPECTED TO BE RETURNED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488883 TECNIS CL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. Z9002 05050474530737

    Patients

    Seq Age Sex Outcome Treatment
    1