BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 12221128 · Received July 23, 2021

    Report

    Report Number
    9614546-2021-07300
    Event Type
    Malfunction
    Date Received
    July 23, 2021
    Date of Event
    June 25, 2021
    Report Date
    December 7, 2021
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    POE
    UDI-DI
    05050474605312
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVALUATION? YES RETURNED TO MANUFACTURER ON: 8/25/2021 DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION REVEALED VISCOELASTIC RESIDUE ON THE OPTIC BODY AND HAPTICS AS WELL AS BEING CUT IN HALF. FURTHERMORE, A SUBSTANCE WAS IDENTIFIED ON THE HAPTICS HOLDING THE TWO LENS HALVES TOGETHER. THE ALLEGED FOREIGN MATERIAL WAS OBSERVED AND WAS FORWARDED TO EAG LABORATORIES FOR FURTHER ANALYSIS. PER EAG LABORATORIES, THE FOREIGN MATERIAL IS IDENTIFIED AS AN ACRYLIC BASED ADHESIVE OR SEALANT CONTAINING FILLERS CONSISTENT WITH CALCIUM CARBONATE AND ALUMINUM SILICATE. THE FOURIER TRANSFORM INFRARED (FTIR) SPECTRUM RAW DATA OUTPUT FILE GENERATED BY EAG LABORATORIES WAS THEN COMPARED AGAINST THE GRONINGEN MANUFACTURING PROCESS FTIR LIBRARY AND DID NOT YIELD ANY RESULTS WITH AT LEAST A 0.90000 CORRELATION. THE TOP HIT WAS ¿000000606HEADCAPROUNDELASTIC¿ WITH A 0.585145 CORRELATION. THE COMPLAINT ISSUE WAS CONFIRMED, HOWEVER DUE TO THE LOW CORRELATION (CORRELATION LESS THAN 0.90000) BETWEEN THE FOREIGN MATERIAL AND THE GRONINGEN MANUFACTURING PROCESS FTIR LIBRARY, IT CANNOT BE CONFIRMED TO BE RELATED TO MANUFACTURING, AS GRONINGEN HAS MANUFACTURING CONTROLS IN PLACE TO PREVENT THE RELEASE OF PRODUCT WITH FOREIGN MATERIAL ON IT. THEREFORE, NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED AT THE MANUFACTURING SITE; THEREFORE, PRODUCT TESTING COULD NOT BE PERFORMED AND THE CUSTOMER¿S REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. THE SEARCH REVEALED THAT NO SIMILAR COMPLAINT FOR THIS PRODUCTION ORDER NUMBER HAS BEEN RECEIVED. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT: UNKNOWN/NOT PROVIDED. IMPLANT DATE: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED DURING THE SAME PROCEDURE. EXPLANT DATE: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED DURING THE SAME PROCEDURE. EMAIL ADDRESS: UNKNOWN, INFORMATION NOT PROVIDED. TELEPHONE NUMBER: (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD A WHITE SUBSTANCE ON THE HAPTIC OF LENS. THE SURGEON IMPLANTED AND EXPLANTED THE LENS AT THE TIME IT WAS OBSERVED AND SUCCESSFULLY REPLACED THE LENS WITH ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER). THERE WAS NO UNPLANNED VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1116851 TECNIS IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO MANUFACTURING NETHERLANDS ZXT150 05050474605312

    Patients

    Seq Age Sex Outcome Treatment
    1 Female