BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 16450665 · Received February 28, 2023

    Report

    Report Number
    3012236936-2023-00515
    Event Type
    Malfunction
    Date Received
    February 28, 2023
    Date of Event
    January 27, 2023
    Report Date
    March 17, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN REVIEW, IT WAS NOTICED THAT THERE WAS A TYPO IN THE DOCTOR'S LAST NAME IN THE INITIAL MDR REPORT. IT WAS ALSO NOTED THAT THE FOLLOWING INFORMATION WAS INADVERTENTLY NOT INCLUDED IN THE FOLLOW UP MDR #1 WHICH HAS BEEN CAPTURED IN THIS SUPPLEMENTAL MDR REPORT AND THE FOLLOWING FIELDS WERE UPDATED ACCORDINGLY: SECTION E1: FIRST/GIVEN NAME: THE FULL FIRST NAME IS UNKNOWN/NOT PROVIDED. ONLY THE FIRST LETTER OF THE FIRST NAME WAS INDICATED TO BE (B)(6). SECTION E1: LAST NAME: (B)(6). SECTION E1: EMAIL ADDRESS: (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE FOLLOWING FIELDS WERE UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED: SECTION B3: DATE OF EVENT: 1/27/2023. SECTION D4: MODEL NUMBER: DIU375. SECTION D4: CATALOG NUMBER: DIU375U190. SECTION D4: SERIAL NUMBER: (B)(6). SECTION D4: EXPIRATION DATE: OCT 13, 2025. SECTION D4: UNIQUE DEVICE IDENTIFIER (UDI #): (B)(4). SECTION D6A: IF IMPLANTED, GIVE DATE: ON (B)(6) 2023. SECTION H4: DEVICE MANUFACTURE DATE: OCT 13, 2022. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN REVIEW, IT WAS NOTICED THAT THE FIELDS " E1 - ESTABLISHMENT NAME, E1 - INITIAL REPORTER'S FULL ADDRESS AND E1 - TELEPHONE NUMBER" WERE INADVERTENTLY NOT ADDRESSED IN SECTION "H10" OF THE INITIAL MDR OR OTHER FOLLOW UP MDR REPORTS; THEREFORE, THE INFORMATION HAS BEEN CAPTURED IN THIS SUPPLEMENTAL MDR REPORT AND THE FOLLOWING FIELDS WERE UPDATED ACCORDINGLY: ADDITIONAL INFORMATION: SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION (THE LENS REMAINS IMPLANTED). THE REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS REVIEW WAS PERFORMED, AND NO NONCONFORMITY REPORT WAS FOUND AS PART OF THIS MANUFACTURING RECORDS REVIEW. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH IN COMPLAINT SYSTEM REVEALED THAT NO OTHER COMPLAINTS WERE RECEIVED FOR THIS PRODUCTION ORDER NUMBER. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY, AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    AGE OR DATE OF BIRTH, WEIGHT, AND ETHNICITY: INFORMATION UNKNOWN; REQUESTED BUT NOT PROVIDED. DATE OF EVENT: EXACT DATE IS UNKNOWN/NOT PROVIDED. BEST ESTIMATE IS ON OR PRIOR TO (B)(6) 2023. CATALOG NUMBER: A COMPLETE CATALOG NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. MODEL NUMBER: A COMPLETE MODEL NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS SERIAL NUMBER WAS NOT PROVIDED. UNIQUE DEVICE IDENTIFIER (UDI #): UNKNOWN, AS SERIAL NUMBER WAS NOT PROVIDED. IMPLANT DATE: IF IMPLANTED; GIVE DATE: UNKNOWN/INFORMATION NOT PROVIDED. EXPLANT DATE IF EXPLANTED; GIVE DATE: NOT APPLICABLE AS THE DEVICE REMAINS IMPLANTED. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE SERIAL NUMBER FOR THIS DEVICE IS UNKNOWN/NOT PROVIDED; THEREFORE, NO FURTHER PRODUCT INVESTIGATION CAN BE PERFORMED. SHOULD ANY FURTHER RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A DOCTOR REPORTED THAT AN EYHANCE TORIC INTRAOCULAR LENS (IOL) MOVED WITHIN 24 HOURS OF PLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799058 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. DIU375

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown