BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 19672207 · Received July 3, 2024

    Report

    Report Number
    3012236936-2024-000183
    Event Type
    Injury
    Date Received
    July 3, 2024
    Report Date
    August 7, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    UDI-DI
    05050474727007
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3A, A3B, A4, A5, A6: UNKNOWN/ NOT PROVIDED. ASKU. SECTION B3: DATE OF EVENT: UNKNOWN, NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: UNKNOWN, NOT PROVIDED. SECTION D6B: IF EXPLANTED, GIVE DATE: UNKNOWN, NOT PROVIDED. SECTION E1: REPORTER NAME: FIRST NAME AND LAST NAME: UNKNOWN, NOT PROVIDED. SECTION E1: EMAIL ADDRESS: UNKNOWN, NOT PROVIDED. SECTION E1: TELEPHONE NUMBER: (B)(6). SECTION H3- NO: 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. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, NO DEFINITIVE RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: UPON REVIEW IT WAS NOTED THAT FIELDS BELOW WERE NOT POPULATED. THEREFORE, THE MISSED INFORMATION HAVE BEEN CAPTURED IN THIS SUPPLEMENTAL MDR REPORT. THE FOLLOWING FIELDS WERE UPDATED ACCORDINGLY: SECTION B2: OUTCOME ATTRIBUTED TO ADVERSE EVENT: BOX FOR "REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES)" SHOULD HAVE BEEN MARKED. SECTION E1: REPORTER NAME: FIRST NAME AND LAST NAME: WAS NOT POPULATED IN THE INITIAL REPORT SUBMITTED. SECTION E3: OCCUPATION: NON-HEALTHCARE PROFESSIONAL SHOULD HAVE BEEN CHOSEN IN THE DROPDOWN LIST. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SURGICAL PROCEDURE WAS PERFORMED USING THE EYHANCE TORIC INTRAOCULAR LENS (IOL). DURING THE PROCEDURE, THE CAPSULE RUPTURED, AND THE DOCTOR PERFORMED SOME PROCEDURES TO ADJUST THE IOL. AFTER THE PROCEDURE, THE PATIENT UNDERWENT REFRACTION, AND HIS VISION WAS VERY GOOD. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544543 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. DIU225 05050474727007

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R