BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 20605582 · Received November 4, 2024

    Report

    Report Number
    3012236936-2024-000284
    Event Type
    Malfunction
    Date Received
    November 4, 2024
    Date of Event
    October 8, 2024
    Report Date
    December 18, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MFK
    UDI-DI
    05050474709843
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE FOLLOWING FIELDS ARE BEING UPDATED PER ADDITIONAL INFORMATION RECEIVED. SECTION B5 - DESCRIBE EVENT OR PROBLEM: ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNED THAT BALANCED SALT SOLUTION (BSS) WAS USED AT ROOM TEMPERATURE, ALONG WITH OXIGLUTATIONE SOLUTION AND BOSMIN. IT WAS TRANSFERRED FROM THE CARTRIDGE CANOPY INTO THE LENS CASE. THE PHYSICIAN PREPARED THE DEVICE, AND REPORTED THAT THE PLUNGER WAS NOT LEFT LOCKED AFTER IT WAS ROTATED. THE PHYSICIAN ALSO REPORTED EXPERIENCING RESISTANCE WHEN THE PLUNGER WAS FIRST PUSHED OUT. SECTION H6. DEVICE CODE(S): 1487 - DEVICE DIFFICULT TO SETUP OR PREPARE ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION D6A - IMPLANT DATE: N/A - LENS WAS NOT IMPLANTED. SECTION D6B - EXPLANT DATE: N/A - LENS WAS NOT IMPLANTED. SECTION E1 - TELEPHONE NUMBER: (B)(6). SECTION H3: THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT 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 AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. AN ATTEMPT HAS BEEN MADE TO OBTAIN THE MISSING INFORMATION. HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: IT WAS INITIALLY REPORTED THAT THE SUSPECT LENS UNDER REPORT 3012236936-2024-0002849 WAS NOT IMPLANTED. HOWEVER, THROUGH THE RETURN PRODUCT INVESTIGATION THIS WAS CLARIFIED AND INSTEAD THE LENS SUBMITTED THROUGH THIS REPORT REMAINS IMPLANTED IN THE PATIENT'S EYE. THEREFORE, THE FOLLOWING FIELDS ARE BEING UPDATED ACCORDINGLY. SECTION B5 - DESCRIBE EVENT OR PROBLEM: LENS REMAINS IMPLANTED. SECTION D6A - IMPLANT DATE: (B)(6) 2024 . SECTION D6B - EXPLANT DATE: LENS REMAINS IMPLANTED. SECTION H6 - TYPE OF INVESTIGATION: 4117 - DEVICE NOT ACCESSIBLE FOR TESTING. ADDITIONAL INFORMATION: SECTION D9 - DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9 - DATE RETURNED TO MANUFACTURER: NOVEMBER 4, 2024. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES . DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR EVALUATION. NO LENS WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE COMPLAINT DEVICE WAS RECEIVED WITH THE PLUNGER ROD COMPLETELY RETRACTED. VISCOELASTIC RESIDUE WAS DISTRIBUTED THROUGH THE LENGTH OF THE CARTRIDGE AND NO ISSUES WERE IDENTIFIED WITH THE CARTRIDGE. THE LENS MODULE WAS INSPECTED REVEALING NO VISCOELASTIC RESIDUE OR DAMAGE. THE DEVICE ASSEMBLY WAS INSPECTED, PRESENTING WITH NO ISSUES. THE PLUNGER ROD ADVANCEMENT WAS INSPECTED AND NO RESISTANCE WAS FELT. THE COMPLAINT ISSUE "LENS DAMAGED" AND "DIFFICULT TO USE" WERE NOT IDENTIFIED DURING PRODUCT EVALUATION. THE OTHER OBSERVED ISSUES DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING OR DESIGN ISSUE. THEREFORE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. CONCLUSION: BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION WERE IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING IMPLANTATION OF THE PRELOADED INTRAOCULAR LENS (IOL), THE LENS WAS TWISTED IN THE CARTRIDGE AND COULD NOT BE IMPLANTED. IT OCCURRED THREE TIMES IN A ROW BEFORE AN IOL WAS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED. A SEPARATE REPORT WILL BE SUBMITTED FOR EACH IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1598672 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO PUERTO RICO MFG. INC. DFR00V 05050474709843

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown