BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS CL IOL

    MDR report key: 12447459 · Received September 9, 2021

    Report

    Report Number
    2020664-2021-07147
    Event Type
    Malfunction
    Date Received
    September 9, 2021
    Date of Event
    July 13, 2021
    Report Date
    December 16, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474530652
    PMA / PMN Number
    P880081
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D-9: DEVICE AVAILABLE FOR EVALUATION: YES SECTION D-9: RETURNED TO MANUFACTURER: YES SECTION D-9: DATE RETURNED TO MANUFACTURER: 27-SEP-2021 SECTION H-3: DEVICE EVALUATED BY MANUFACTURER: YES DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION REVEALED VISCOELASTIC RESIDUE ON THE OPTIC BODY AND HAPTICS WHICH IS CONSISTENT WITH A LENS THAT WAS HANDLED PRIOR TO INSERTION. A BROWN SPOT ON THE LENS WAS OBSERVED, WHICH MAY HAVE BEEN THE ALLEGED FOREIGN MATERIAL AND WAS THEREFORE WAS SENT TO AN INDEPENDENT LABORATORIES FOR FURTHER ANALYSIS. PER INDEPENDENT LABORATORIES, FOURIER TRANSFORM INFRARED (FTIR) ANALYSIS INDICATES THE SAMPLE IS CONSISTENT WITH A POLYESTER MATERIAL. THE FTIR SPECTRUM RAW DATA OUTPUT FILE GENERATED BY THE INDEPENDENT LABORATORIES WAS THEN COMPARED AGAINST THE JOHNSON & JOHNSON SURGICAL VISION (JJSV) MANUFACTURING PROCESS FTIR LIBRARY AND DID NOT YIELD ANY RESULTS WITH AT LEAST A 0.900000 CORRELATION. THE TOP HIT WAS ¿RE-USABLELABCOAT/COVERALL¿ WITH A 0.663728 CORRELATION. THE COMPLAINT ISSUE WAS CONFIRMED, HOWEVER DUE TO THE LOW CORRELATION (CORRELATION LESS THAN 0.90000) BETWEEN THE FOREIGN MATERIAL AND THE JJSV MANUFACTURING PROCESS FTIR LIBRARY IT CANNOT BE CONFIRMED IF THE ISSUE IS RELATED TO HANDLING OR MANUFACTURING, BECAUSE JJSV 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 RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED AND NO NON-CONFORMANCE REPORT WAS FOUND AS PART OF THIS MANUFACTURING RECORDS REVIEW. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. HISTORICAL DATA ANALYSIS: A SEARCH IN COMPLAINT SYSTEM REVEALED THAT NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS PRODUCTION ORDER NUMBER. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT MALFUNCTION OR PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT AND ETHNICITY AND RACE: UNKNOWN AS INFORMATION WAS NOT PROVIDED. DATE IMPLANTED: NOT APPLICABLE AS THE IOL WAS NOT IMPLANTED. DATE EXPLANTED: NOT APPLICABLE AS THE IOL WAS NOT IMPLANTED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE INSERTING THE INTRAOCULAR LENS (IOL) THERE WAS DEBRIS ON THE LENS AND THE CARTRIDGE HAD CONTACT WITH THE PATIENT'S OCULAR DEXTER (RIGHT EYE). THE IOL WAS REMOVED AND REPLACED IN THE SAME PROCEDURE WITH ANOTHER LENS WITH THE SAME MODEL AND DIOPTER SIZE. THERE WAS NO MEDICAL INTERVENTION AND NO SURGICAL INTERVENTION. OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. PATIENT STATUS POST-PROCEDURE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1342680 TECNIS CL IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. Z9002 05050474530652

    Patients

    Seq Age Sex Outcome Treatment
    1 Female