BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 15214684 · Received August 11, 2022

    Report

    Report Number
    3012236936-2022-02108
    Event Type
    Malfunction
    Date Received
    August 11, 2022
    Report Date
    September 30, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474528888
    PMA / PMN Number
    P990080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS REMAINS IMPLANTED. TELEPHONE NUMBER: (B)(6). THE DEVICE IS NOT RETURNING FOR EVALUATION AS IT REMAINS IMPLANTED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE RECORD AND COMPLAINT TRENDING FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION D9. DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: AUG. 17, 2022. SECTION H3. DEVICE EVALUATED MANUFACTURER? YES. DEVICE EVALUATION: THE ALLEGED FOREIGN MATERIAL WAS RECEIVED TAPED TO THE ORIGINAL LENS CASE. THE ALLEGED FOREIGN MATERIAL WAS SENT TO EAG FOR FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS. EAG LABORATORIES ANALYSIS: A MATERIAL ANALYSIS REPORT WAS REQUESTED FOR THE FOREIGN MATERIAL. PER EAG LABORATORIES, THE FOREIGN SUBSTANCE TESTED IS CONSISTENT WITH A POLYAMIDE RESIN SIMILAR TO NYLON 6,6. THE SAMPLE MAY ALSO CONTAIN GLASS FILLER MATERIAL AND EXHIBITS RESIDUE FROM THE ACRYLIC ADHESIVE USED TO SECURE THE SAMPLE TO THE CARTRIDGE WHEEL. THE FTIR SPECTRUM RAW DATA OUTPUT FILE GENERATED BY EAG LABORATORIES WAS THEN COMPARED AGAINST THE AÑASCO MANUFACTURING PROCESS FTIR LIBRARY YIELDED NO RESULT WITH AT LEAST A 0.90000 CORRELATION. THE TOP HIT FOR THE SWAB WAS ¿TX752BCLEAN TIP SWAB¿ WITH A 0.39765704 CORRELATION. NO ADDITIONAL MATCHES WERE IDENTIFIED. THE COMPLAINT ISSUE "DC-FOREIGN MATERIAL - LOOSE" WAS IDENTIFIED DURING PRODUCT EVALUATION; HOWEVER, BASED ON THE COMPLAINT INVESTIGATION RESULTS THE COMPLAINT ISSUE COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. THE ORIGIN OF THE ALLEGED FOREIGN MATERIAL CANNOT BE DETERMINED TO BE PART OF MANUFACTURING PROCESS AND IS THEREFORE INCONCLUSIVE. THE MANUFACTURING FTIR LIBRARY IS NOT ALL INCLUSIVE FOR MATERIALS FOUND OUTSIDE OF THE MANUFACTURING PROCESS. FURTHERMORE, MANUFACTURING SITE HAS MANUFACTURING CONTROLS IN PLACE TO PREVENT THE RELEASE OF PRODUCT WITH FOREIGN MATERIAL ON IT. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN AN INTRAOCULAR LENS (IOL) WAS BEING IMPLANTED, FOREIGN MATTER LOOKED LIKE A PART OF THE HAPTIC WAS OBSERVED IN THE PATIENT¿S EYE, AND IT WAS REMOVED. THERE WAS NO PATIENT INJURY. THERE WAS NO RETURNING PRODUCT BECAUSE THE LENS REMAINS IMPLANTED. THE IMPLANTATION METHOD WAS PROPER, AND THERE HAD BEEN NO FEELINGS OF STRANGENESS OR RESISTANCE. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302446 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZA9003 05050474528888

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown