BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 21692702 · Received March 25, 2025

    Report

    Report Number
    3012236936-2025-000072
    Event Type
    Injury
    Date Received
    March 25, 2025
    Date of Event
    February 25, 2025
    Report Date
    May 19, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    UDI-DI
    05050474740440
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9 - DEVICE AVAILABLE FOR EVALUATION? YES SECTION D9 - DATE RETURNED TO MANUFACTURER: MARCH 17, 2025 SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES DEVICE EVALUATION: THE HANDPIECE WAS INSPECTED UNDER MAGNIFICATION. THE COMPLAINT HANDPIECE WAS RECEIVED WITH THE LENS MODULE CARTRIDGE ASSEMBLY REMOVED FROM THE HANDPIECE AND THE LENS MODULE CARTRIDGE ASSEMBLY WAS MISSING. THE PLUNGER ROD WAS BENT AND THE HANDPIECE WAS DAMAGED. BECAUSE OF THE RETURN CONDITION, NO FURTHER HANDPIECE EVALUATION CAN BE PERFORMED. NO LENS WAS RECEIVED FOR EVALUATION. THE COMPLAINT ISSUES "DIFFICULT TO USE" AND "DEVICE ADVANCEMENT ISSUE" WERE NOT IDENTIFIED DURING PRODUCT EVALUATION. THE OTHER OBSERVED ISSUES COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. CONCLUSION: BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION WERE FOUND. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION D6A - IMPLANT DATE: NOT APPLICABLE, AS THE LENS WAS NOT IMPLANTED. SECTION D6B - EXPLANT DATE: NOT APPLICABLE, AS THE LENS WAS NOT IMPLANTED. SECTION E1 - EMAIL ADDRESS: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION E1 - TELEPHONE NUMBER: (B)(6). SECTION G4 - PMA/510(K) #: THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS EYHANCE SIMPLICITY TORIC II OPTIBLUE WITH TECNIS SIMPLICITY, MODEL DIW SERIES THAT HAS A SIMILAR DEVICE, TECNIS EYHANCETORIC II IOL WITH TECNIS SIMPLICITY MODEL DIU WHICH IS DISTRIBUTED IN THE UNITED STATES UNDER PMA P980040. SECTION H3: 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. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION. HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ACCOUNT EXPERIENCED A STRANGE SENSATION WHEN THE PLUNGER OF THE PRELOADED TORIC INTRAOCULAR LENS (IOL) WAS PUSHED FORWARD WHILE SETTING THE LENS. THE PHYSICIAN FELT A RESISTANCE WHEN TURNING THE PLUNGER AND COULD NOT FURTHER ADVANCE THE IOL WHILE PROCEEDING FORWARD. THEREFORE, A REPLACEMENT LENS WAS PREPARED. HOWEVER, A SIMILAR SITUATION OCCURRED WITH THE REPLACEMENT LENS, AND IT WAS NOT POSSIBLE TO IMPLANT IT. THERE WAS NO PATIENT CONTACT WITH THE DEVICES. THE PROCEDURE WAS NOT COMPLETED AND THE PATIENT WAS LEFT APHAKIC. ON THE FOLLOWING DAY, THE SURGERY WAS PERFORMED AGAIN USING THE SAME MODEL LENS AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEM. NO PATIENT INJURY WAS REPORTED. NO MEDICAL INTERVENTION WAS REQUIRED. THROUGH FOLLOW-UP, WE LEARNED THAT THE DEVICES WERE PREPARED BY THE PHYSICIAN WITH BALANCED SALT SOLUTION (BSS) AND IT WAS INTRODUCED FROM THE CARTRIDGE CANOPY. NO FURTHER INFORMATION WAS PROVIDED. A SEPARATE REPORT WILL BE SUBMITTED FOR THE OTHER LENS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1121491 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. DIW225 05050474740440

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention