BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 21531779 · Received March 5, 2025

    Report

    Report Number
    3012236936-2025-000047
    Event Type
    Malfunction
    Date Received
    March 5, 2025
    Date of Event
    February 11, 2025
    Report Date
    April 29, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474655485
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9 - DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9 - DATE RETURNED TO MANUFACTURER: 04-MAR-2025. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: A PHOTOGRAPH WAS PROVIDED BY THE CUSTOMER FOR EVALUATION. THE PHOTOGRAPH SHOWED THE COMPLAINT CARTRIDGE, AND MATERIAL CAN BE OBSERVED ON THE END OF THE CARTRIDGE TIP. VISUAL INSPECTION WAS PERFORMED ON THE SUSPECT PRODUCT. THE PLUNGER ROD WAS FOUND ADVANCED TO A LENS THAT WAS STUCK IN THE CARTRIDGE. VISCOELASTIC RESIDUE WAS OBSERVED TO BE DISTRIBUTED THROUGH THE LENGTH OF THE CARTRIDGE, AND MATERIAL APPEARED TO BE IN THE TIP OF THE CARTRIDGE. THE CARTRIDGE TIP WAS ALSO DAMAGED. A PIECE OF MATERIAL WAS IDENTIFIED TO BE IN THE BAG. THE MATERIAL INSIDE THE BAG WAS LIKE THE MATERIAL THAT WAS IDENTIFIED IN THE CARTRIDGE TIP. THE DEVICE AND THE MATERIAL WERE FURTHER EVALUATED. THE ANALYSIS OF THE MATERIAL WAS CONSISTENT WITH A MIXTURE POSSIBLY CONTAINING A METHACRYLATE SPECIES, AN ACRYLIC ACID SALT, AND A VINYL POLYMER SIMILAR TO POLYVINYL PYRROLIDINE. THE FOURIER TRANSFORM INFRARED (FTIR) SPECTRUM RAW DATA OF THE MATERIAL WAS COMPARED AGAINST THE MANUFACTURING PROCESS FTIR LIBRARY AND DID NOT YIELD ANY RESULTS WITH AT LEAST A 0.90000 CORRELATION. THE COMPLAINT ISSUE "DC-FOREIGN MATERIAL - LOOSE" WAS IDENTIFIED DURING PRODUCT AND PHOTO EVALUATION; HOWEVER, BASED ON THE COMPLAINT INVESTIGATION RESULTS THE COMPLAINT ISSUE COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. THEREFORE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. 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 WHEN THE SURGEON ADVANCED THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) OUT OF THE CARTRIDGE DURING SURGERY, A FOREIGN BODY CAME OUT OF THE INJECTOR BEFORE THE LENS DID. THE SURGEON WAS ABLE TO RETRIEVE THE FOREIGN BODY FROM THE PATIENT'S EYE AND THIS DID NOT AFFECT THE SURGICAL OUTCOME. THE FOREIGN BODY LOOKED LIKE A PIECE OF CLEAR PLASTIC. THROUGH FOLLOW UP, WE LEARNED THE IOL WAS NOT IMPLANTED. NO ADDITIONAL SURGICAL OR MEDICAL INTERVENTIONS WERE REQUIRED. THE SURGEON SAW THE FRAGMENT IN THE LUMEN OF THE INJECTOR AS HE PROPELLED THE LENS FORWARDS. THE PROCEDURE WAS DELAYED FOR 2 MINUTES, WHILST THE SURGEON AWAITED A NEW LENS. THROUGH FURTHER FOLLOW UP, WE LEARNED THAT THE FRAGMENT WAS DISCOVERED WITHIN THE CORNEAL SECTION AND POSSIBLY ENTERED THE ANTERIOR CHAMBER. THE SURGEON COULD NOT INITIALLY WORK OUT WHETHER IT WAS THE LEADING HAPTIC WHILST IT WAS IN THE CHAMBER. AS SOON AS HE IDENTIFIED THAT IT WAS A FOREIGN BODY, HE WITHDREW IT WITH A PAIR OF FORCEPS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487001 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474655485

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown