BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 19635324 · Received June 28, 2024

    Report

    Report Number
    3012236936-2024-000183
    Event Type
    Malfunction
    Date Received
    June 28, 2024
    Date of Event
    March 26, 2024
    Report Date
    August 22, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MFK
    UDI-DI
    05050474709911
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION AND CORRECTED DATA: AS PER THE ADDITIONAL INFORMATION RECEIVED, CORRECTION IS REQUIRED FOR THE FOLLOWING FIELDS: SECTION B5 - DESCRIBE EVENT OR PROBLEM: THE LENS WAS SCRATCHED BY THE INJECTOR, DURING THE PASSING OF THE LENS. SECTION D1 - BRAND NAME: TECNIS IOL. SECTION D2A - COMMON DEVICE NAME: LENS, MULTIFOCAL INTRAOCULAR. SECTION D2B - DEVICE PRODUCT CODE: MFK. SECTION D4 - MODEL NUMBER: DFR00V. SECTION D4 - CATALOG NUMBER: DFR00VI220. SECTION D4 - SERIAL NUMBER: (B)(6). SECTION D4 - EXPIRATION DATE: 06-FEB-2025. SECTION D4 - UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4). SECTION H4 - DEVICE MANUFACTURE DATE: 06-FEB-2022 SECTION H6 - MEDICAL DEVICE PROBLEM CODE: 3020 - SCRATCHED MATERIAL . ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2, A4 AND A5: PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION B3 - DATE OF EVENT: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION D4 - MODEL NUMBER: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D4 - CATALOG NUMBER: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D4 - SERIAL NUMBER: UNKNOWN/ NOT PROVIDED, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION D4 - EXPIRATION DATE: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D4 - UDI NUMBER: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS THE LENS WAS NOT IMPLANTED. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE LENS WAS NOT IMPLANTED. (B)(6) SECTION H3 - THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE CUSTOMER. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. AS THE SERIAL NUMBER IS UNKNOWN NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4 - DEVICE MANUFACTURE DATE: UNKNOWN, AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. AN ATTEMPT HAS BEEN MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION AND CORRECTED DATA: SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. THE FOLLOWING FIELDS ARE BEING UPDATED PER NEW INFORMATION RECEIVED: SECTION B3 - DATE OF EVENT: 26-MAR-2024. SECTION B5 - DESCRIBE EVENT OR PROBLEM: THROUGH FOLLOW-UP WE LEARNED THAT THE LENS BECAME STUCK IN THE CARTRIDGE AND BROKE WHEN PRESSURE WAS APPLIED WITH THE INSERTION PLUNGER IN AN ATTEMPT TO MOVE IT. SECTION H6 - DEVICE CODE(S): 1069 - BREAK, 2983 - MECHANICAL JAM. DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE REPORTED ISSUE COULD NOT BE VERIFIED, AND PRODUCT QUALITY DEFICIENCY COULD NOT BE DETERMINED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH OF COMPLAINTS RELATED TO THIS PRODUCTION ORDER (PO) WAS PERFORMED. THE SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS WERE RECEIVED FOR THIS PO. NO ESCALATION REQUIRED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THREE INTRAOCULAR LENSES (IOLS) BROKE DURING IMPLANTATION, NECESSITATING THE USE OF BACKUP LENSES TO COMPLETE THE SURGERY. THE BROKEN IOLS WERE DISCARDED BY THE CUSTOMER. NO ADDITIONAL DETAILS WERE PROVIDED. THIS IS REPORT 3 OF 3. A SEPARATE REPORT IS BEING SUBMITTED FOR EACH OF THE LENSES INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2184486 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO PUERTO RICO MFG. INC. DFR00V 05050474709911
    913806 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO PUERTO RICO MFG. INC. DFR00V 05050474709911

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose