BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 18603362 · Received January 29, 2024

    Report

    Report Number
    3012236936-2024-00217
    Event Type
    Injury
    Date Received
    January 29, 2024
    Date of Event
    January 3, 2024
    Report Date
    March 31, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    UDI-DI
    05050474725881
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES. DATE RETURNED TO MANUFACTURER: JAN 29, 2024. SECTION H3: DEVICE RETURNED TO MANUFACTURER: YES. DEVICE EVALUATION: VISUAL INSPECTION OF THE COMPLAINT SIMPLICITY REVEALS NO DAMAGE TO THE CARTRIDGE OR PLUNGER. OVD WAS OBSERVED THROUGHOUT THE CARTRIDGE INDICATING THAT A SUFFICIENT AMOUNT OF OVD WAS USED. THE LENS WAS RECEIVED IN A VIAL AND WAS INSPECTED, AND OBSERVED TO BE CUT INTO THREE PIECES CONSISTENT WITH A LENS THAT WAS REMOVED AFTER IMPLANTATION. NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLAINT ISSUE WAS OBSERVED. PHOTOS WERE PROVIDED AND EVALUATED. THE FIRST PHOTO IS OF THE SUSPECT HANDPIECE ON A TABLE; NO DAMAGE COULD BE OBSERVED. THE SECOND PHOTO DISPLAYS THE SUSPECT LENS IN THE PATIENT¿S EYE AND A SCRATCH COULD BE OBSERVED ON THE LENS. THE COMPLAINT ISSUE "LENS DAMAGED" AND "STUCK IN CARTRIDGE" WERE NOT IDENTIFIED DURING PHOTO AND PRODUCT EVALUATION. THE OBSERVED "COSMETIC ISSUES" IS SIMILAR TO THE REPORTED COMPLAINT ISSUE "LENS DAMAGED". HOWEVER, BASED ON THE COMPLAINT INVESTIGATION RESULTS THE COMPLAINT ISSUE COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. NO NONCONFORMITY REPORT, DOCUMENTATION OR LABELING CHANGES, AND FURTHER ESCALATIONS ARE REQUIRED. JOHNSON & JOHNSON SURGICAL VISION WILL CONTINUE TO MONITOR THESE TYPES OF COMPLAINTS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2, A4 AND A5: DOB, AGE, WEIGHT, RACE AND ETHNICITY: UNKNOWN/ NOT PROVIDED. 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. SECTION E1: EMAIL ADDRESS: UNKNOWN/NOT PROVIDED. SECTION E1: TELEPHONE NUMBER: 042)476-0075 SECTION H3: OTHER 81: THE DEVICE WAS NOT RETURNED 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 THERE WAS A CRACK IN THE OPTIC CENTRAL PART OF THE LENS AFTER THE LENS WAS IMPLANTED INTO THE PATIENT'S EYE. THERE WAS A DEVICE ADVANCEMENT ISSUE THAT CAUSED THE IOL TO BE DAMAGED. THERE WAS EDEMA AFTER THE SURGERY. THE IOL WAS REMOVED AND REPLACED. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2552707 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. DIU100 05050474725881

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R