BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 21830719 · Received April 11, 2025

    Report

    Report Number
    3012236936-2025-000102
    Event Type
    Malfunction
    Date Received
    April 11, 2025
    Report Date
    June 9, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474531758
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION AND DEVICE/PHOTO EVALUATION: THE SERIAL NUMBER OF THE ZCB00 LENS WAS PROVIDED AS (B)(6). THE FOLLOWING SECTIONS HAVE BEEN UPDATED ACCORDINGLY: SECTION D4: MODEL NUMBER: ZCB00. SECTION D4: CATALOG NUMBER: ZCB0000220. SECTION D4: SERIAL NUMBER: (B)(6). SECTION D4: EXPIRATION DATE: FEB 7, 2028. SECTION D4: UNIQUE DEVICE IDENTIFIER (UDI #): (B)(4). SECTION D9: DEVICE AVAILABLE FOR EVALUATION: NO. HOWEVER, PHOTO WAS PROVIDED FOR EVALUATION. SECTION D9: RETURNED TO MANUFACTURER ON: NOT APPLICABLE AS DEVICE IS NOT RETURNED. HOWEVER, PHOTO WAS PROVIDED. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: NO. HOWEVER, THE PHOTO WAS EVALUATED. DEVICE/PHOTO EVALUATION: NO SUSPECT PRODUCT WAS RECEIVED; HOWEVER, A PHOTO WAS PROVIDED BY THE CUSTOMER. THE CUSTOMER PROVIDED PHOTO WAS EVALUATED BY A POST MARKET SAFETY SURVEILLANCE OFFICER. THE PICTURE SHOWS AROUND 6 WHITISH PARTICLE LIKE IMAGES, MAJORITY LOCATED IN THE SPACE BETWEEN THE LENS OPTICAL EDGE AND THE HAPTIC. THE PARTICLE NATURE, ITS POTENTIAL ROOT CAUSE AND THE CLINICAL IMPACT OF THE INCIDENT CANNOT BE DETERMINED FROM A PHOTO ASSESSMENT. NO FURTHER ISSUES WERE IDENTIFIED, AND NO FURTHER EVALUATION WAS PERFORMED. HRA (HEALTH RISK ASSESSMENT) AND HUMAN RISK FACTOR DOCUMENTS WERE REVIEWED FOR THE COMPLAINT ISSUE REPORTED. THE RESULTS OF THIS HRA AND HUMAN RISK FACTORS REVIEW DO NOT CONFIRM THAT THE ABOVE SITUATIONS OCCURRED DURING MANUFACTURING. CONCLUSION: THE COMPLAINT ISSUE "FOREIGN MATERIAL - LOOSE" WAS IDENTIFIED DURING PHOTO EVALUATION. HOWEVER, BASED ON THE COMPLAINT INVESTIGATION RESULTS THE COMPLAINT ISSUE COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. SECTION H4: DEVICE MANUFACTURE DATE: FEB 7, 2024. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION D4: CATALOG NUMBER: A COMPLETE CATALOG NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: EXPIRATION DATE: UNKNOWN, AS SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: UNIQUE DEVICE IDENTIFIER (UDI #): UNKNOWN, AS SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, REMAINS IMPLANTED IN THE EYE. SECTION E1: REPORTER TELEPHONE NUMBER: (B)(6). SECTION H3: OTHER 81: THE DEVICE WAS NOT RETURNED FOR EVALUATION AS THE LENS REMAIN IMPLANTED IN THE EYE. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN AS SERIAL NUMBER WAS NOT PROVIDED. ATTEMPTS HAVE 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.

    Additional Manufacturer Narrative · 0

    CORRECTION: IN SUPPLEMENTAL #1 IT WAS INDICATED THE SN WAS (B)(6) AND FIELDS WERE UPDATED TO REFLECT THAT (D4 CATALOG, EXPIRATION DATE, MANUFACTURING DATE, UDI) HOWEVER, IT WAS NOTICED THAT THERE WAS A TYPO ERROR AND THE CORRECT SERIAL NUMBER OF THE DEVICE IS 2178312406. THEREFORE, THE FOLLOWING FIELDS ARE BEING UPDATED: SECTION D4: CATALOG NUMBER: ZCB0000225. SECTION D4: SERIAL NUMBER: (B)(6). SECTION D4: EXPIRATION DATE: FEB 5, 2028. SECTION D4: UNIQUE DEVICE IDENTIFIER (UDI #): (B)(4). SECTION H4: DEVICE MANUFACTURE DATE: FEB 5, 2024. ADDITIONAL INFORMATION: ADDITIONAL INFORMATION RECEIVED STATED THAT NO ADDITIONAL CASES/ADVERSE EVENTS RECOGNIZED. THERE WAS NO FOREIGN MATERIAL REMOVED DURING IMPLANTATION AND PATIENT WAS NOT AWARE OF IT. THERE WERE NO FURTHER COMMENTS FROM SURGEON. THE CARTRIDGE MODEL AND SERIAL NUMBER ARE UNAVAILABLE AND IT IS ALSO NOT AVAILABLE FOR RETURN. THERE ARE NO ADVERSE EFFECTS/INJURIES TO THE PATIENT AFTER IMPLANTATION OF LENS AND FOREIGN MATERIAL INTO EYE. NO MEDICAL/SURGICAL INTERVENTION REQUIRED. NOTHING UNUSUAL WITH PATIENT OUTCOME. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SURGEON FOUND SOME FOREIGN MATERIALS INSIDE THE EYE AFTER THE IMPLANTATION OF NON-PRELOADED INTRAOCULAR LENS (IOL), WHICH WAS NOT REMOVED EVEN BY IRRIGATION AND ASPIRATION (I/A) PROCESS. DESPITE THE UNEXPECTED RESULT, THE SURGEON DECIDED NOT TO EXTRACT THE IOL AS THE PATIENT WAS TOO ELDERLY TO GO THROUGH THIS COMPLICATED PROCEDURES. BUT THE SURGEON WANTS TO BE AWARE OF THE POSSIBLE IMPACT THIS MATERIAL INVOLVED COULD HAVE ON THE PATIENT¿S EYE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006868 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZCB00 UNK 05050474531758

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown