BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 19714956 · Received July 10, 2024

    Report

    Report Number
    3012236936-2024-000194
    Event Type
    Malfunction
    Date Received
    July 10, 2024
    Date of Event
    May 27, 2024
    Report Date
    February 3, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    UDI-DI
    05050474727014
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES. DATE RETURNED TO MANUFACTURER: 21 AUG 2024. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: VISUAL INSPECTION WAS PERFORMED ON THE SUSPECT PRODUCT AND FOUND THE PLUNGER ROD WAS FULLY ADVANCED AND THE CARTRIDGE TIP AND PLUNGER ROD TIP WERE OBSERVED DAMAGED. NO FOREIGN MATERIAL COULD BE IDENTIFIED VIA EXTERNAL VISUAL INSPECTION. THE LENS MODULE WAS INSPECTED, AND NO FOREIGN MATERIAL WAS IDENTIFIED. THE LENS WAS INVESTIGATED UNDER MAGNIFICATION. THE LENS WAS RECEIVED TAPED TO A PIECE OF PAPER AND THE TAPE WAS REMOVED AND DAMAGE TO THE OPTIC BODY WAS OBSERVED. A DARK SPOT COULD BE OBSERVED IN ONE OF THE DAMAGE MARKS. THE LENS WAS FORWARDED TO LAB FOR FOREIGN MATERIAL EVALUATION. PER THE LAB, A THOROUGH INSPECTION OF THE LENS UNDER A STEREO MICROSCOPE REVEALED NO DARK PARTICLE IN THE AREA OF INTEREST. THE SUSPECTED PARTICLE WAS LIKELY AN OPTICAL ARTIFACT, SUCH AS A SHADOW. THE PRODUCT WAS LOST BY THE COURIER WHILE IN TRANSIT BACK TO THE INVESTIGATION SITE AND NO FURTHER EVALUATION CAN BE PERFORMED. THE COMPLAINT ISSUE WAS IDENTIFIED DURING PRODUCT EVALUATION; HOWEVER, BASED ON THE LAB RESULTS THE COMPLAINT ISSUE COULD NOT BE CONFIRMED. THEREFORE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. MANUFACTURING RECORD EVALUATION: BASED ON THE MANUFACTURING RECORDS REVIEW, AND HISTORICAL COMPLAINT REVIEW, THERE IS NO INDICATION OF A PRODUCT MALFUNCTION OR PRODUCT QUALITY DEFICIENCY. THE MANUFACTURING RECORDS REVIEW FOR THIS PRODUCTION ORDER SHOWS THAT THE UNITS WERE RELEASED WITHIN SPECIFICATION. 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 · 0

    PATIENT INFORMATION CANNOT BE PROVIDED DUE TO PERSONAL DATA PRIVACY LEGISLATION/POLICY SECTION D6A: IMPLANT DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. SECTION D6B: EXPLANT DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. (B)(6). SECTION H3 IT WAS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN DOCTOR IMPLANTED THE IOL, SHE FOUND THAT THERE WAS A FOREIGN BODY IN THE IOL BODY. IOL WAS REMOVED AND A NEW IOL WAS USED TO REPLACE AND COMPLETE THE SURGERY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362240 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. DIU225 05050474727014

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose