BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS 1-PIECE

    MDR report key: 10434194 · Received August 20, 2020

    Report

    Report Number
    2648035-2020-00628
    Event Type
    Malfunction
    Date Received
    August 20, 2020
    Date of Event
    May 18, 2020
    Report Date
    October 29, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474531635
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE (B)(4) AND CAPA (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 8/10/2020 DEVICE RETURNED TO MANUFACTURER ¿ YES. DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION REVEALED A DETACHED HAPTIC, WHAT APPEARED TO BE VISCOELASTIC RESIDUE ON THE OPTIC BODY AND HAPTICS, AND THAT THE LENS WAS RECEIVED CUT IN HALF, WHICH IS CONSISTENT WITH A LENS THAT WAS HANDLED DURING REMOVAL AND REPLACEMENT. FURTHERMORE, A FIBER WAS OBSERVED ON THE OPTIC BODY OF THE LENS HALF WITH THE DETACHED HAPTIC, WHICH MAY HAVE BEEN THE ¿DEBRIS ON LENS¿ DESCRIBED BY THE CUSTOMER. THE LENS AND FOREIGN MATERIAL WERE FORWARDED TO EAG LABORATORIES FOR FOREIGN MATTER ANALYSIS. THE LENS WAS SENT TO EAG LABORATORIES FOR FURTHER ANALYSIS OF WHAT APPEARED TO BE A FIBER ON THE OPTIC BODY, WHICH MAY HAVE BEEN THE "DEBRIS ON LENS" AS DESCRIBED BY THE CUSTOMER. FTIR ANALYSIS INDICATES THAT THE FOREIGN MATERIAL IS A MIXTURE OF A CELLULOSIC MATERIAL (E.G. COTTON, RAYON, LINT) AND AN INORGANIC CARBONATE SIMILAR TO CALCIUM CARBONATE. THE COMPLAINT ISSUE WAS CONFIRMED, HOWEVER DUE TO THE LOW CORRELATION (CORRELATION LESS THAN 0.90000) BETWEEN THE FOREIGN MATERIAL AND THE AÑASCO MANUFACTURING PROCESS FTIR LIBRARY IT CANNOT BE CONFIRMED IF THE ISSUE IS RELATED TO HANDLING OR MANUFACTURING, BECAUSE AÑASCO HAS MANUFACTURING CONTROLS IN PLACE TO PREVENT THE RELEASE OF PRODUCT WITH FOREIGN MATERIAL ON IT, AND THEREFORE NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. A SEARCH OF COMPLAINTS REVEALED TWO OTHER COMPLAINTS WERE RECEIVED UNDER THIS PRODUCTION ORDER; HOWEVER, THESE COMPLAINT ISSUES ARE UNRELATED; THEREFORE, NO ESCALATIONS ARE REQUIRED. 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

    AGE/DATE OF BIRTH: UNKNOWN/NOT PROVIDED. IF IMPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE INTRAOCULAR LENS WAS INSERTED AND REMOVED DURING THE SAME PROCEDURE. IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE INTRAOCULAR LENS WAS INSERTED AND REMOVED DURING THE SAME PROCEDURE. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER INSERTION OF AN INTRAOCULAR LENS (IOL) IN THE PATIENT'S LEFT EYE, DEBRIS WAS OBSERVED ON THE LENS. THE LENS WAS REMOVED AND REPLACED IN THE SAME PROCEDURE. THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897662 TECNIS 1-PIECE MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZCB00 05050474531635

    Patients

    Seq Age Sex Outcome Treatment
    1