BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 20909342 · Received December 11, 2024

    Report

    Report Number
    3012236936-2024-000321
    Event Type
    Malfunction
    Date Received
    December 11, 2024
    Date of Event
    November 18, 2024
    Report Date
    February 25, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636514
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION E1 - TELEPHONE NUMBER: (B)(6). SECTION G4: PMA/510(K) NUMBER: THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS OPTIBLUE PRELOADED 1-PIECE IOL, MODEL DCB00V THAT HAS A SIMILAR DEVICE, TECNIS SIMPLICITY PRELOADED 1-PIECE IOL MODEL DCB00 WHICH IS DISTRIBUTED IN THE UNITES STATES UNDER PMA P980040. 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

    ADDITIONAL INFORMATION: SECTION D9 - DEVICE AVAILABLE FOR EVALUATION? YES SECTION D9 - DATE RETURNED TO MANUFACTURER: 03-FEB-2025 SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES DEVICE EVALUATION: THE DEVICE WAS INSPECTED UNDER MAGNIFICATION. THE COMPLAINT DEVICE WAS RECEIVED WITH THE PLUNGER ROD FULLY RETRACTED. THE MATERIAL COULD BE IDENTIFIED ON THE PLUNGER ROD AROUND THE AREA INDICATED BY A CUSTOMER NOTE ATTACHED TO THE HANDPIECE TRAY. THE LENS MODULE PRESENTED WITH NO LENS AND THE CARTRIDGE SHOWED VISCOELASTIC RESIDUE INSIDE THROUGH THE LENGTH OF THE CARTRIDGE. THERE WAS AN OPAQUE MATERIAL ON THE EXTERIOR OR THE CARTRIDGE; HOWEVER, THE MATERIAL DID NOT MATCH WHAT IS DESCRIBED IN THE COMPLAINT. THE MATERIAL WAS IDENTIFIED TO BE ACRYLONITRILE BUTADIENE STYRENE (ABS). ADDITIONALLY, THE EXCISED BLACK FOREIGN MATERIAL WAS ALSO ABS AND CONTAINED TRACE AMOUNTS OF ALUMINOSILICATES (ALSO KNOWN AS ¿DIRT¿). FOURIER TRANSFORM INFRARED (FTIR) AND ENERGY-DISPERSIVE X-RAY SPECTROSCOPY (EDS) ANALYSIS INDICATE THAT THE FOREIGN MATERIAL WAS LIKELY OXIDIZED BURNED ABS. THE FTIR SPECTRUM RAW DATA OUTPUT FILE GENERATED WAS COMPARED AGAINST THE MANUFACTURING PROCESS FTIR LIBRARY AND DID NOT YIELD ANY RESULTS WITH AT LEAST A 0.90000 CORRELATION. THE COMPLAINT ISSUE "FOREIGN MATERIAL - LOOSE" WAS IDENTIFIED DURING PRODUCT EVALUATION. CONCLUSION: BASED ON THE COMPLAINT INVESTIGATION RESULTS AND THE AVAILABLE INFORMATION, NO DEFICIENCY OR PRODUCT MALFUNCTION WAS CONFIRMED. 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 DEVICE BOX WAS OPENED TO IMPLANT THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), SOMETHING LIKE RED PAINT WAS FOUND CLOSER TO THE TIP THAN THE PLUNGER ROD. THE PHYSICIAN CONSIDERED THAT THERE WAS NO EFFECT ON THE IOL BECAUSE IT WAS STERILIZED, AND THE IOL WAS IMPLANTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED. NO MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2153988 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00V 05050474636514

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown