BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 21580139 · Received March 11, 2025

    Report

    Report Number
    3012236936-2025-000071
    Event Type
    Malfunction
    Date Received
    March 11, 2025
    Date of Event
    February 8, 2025
    Report Date
    May 1, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636781
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D6A: IF IMPLANTED, GIVE DATE: N/A, AS THE LENS WAS NOT IMPLANTED. SECTION D6B: IF EXPLANTED, GIVE DATE: N/A, AS THE LENS WAS NOT IMPLANTED. 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. ATTEMPTS HAVE 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9 - DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9 - DATE RETURNED TO MANUFACTURER: MARCH 10, 2025. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: THE HANDPIECE WAS INSPECTED UNDER MAGNIFICATION. THE COMPLAINT DEVICE WAS RECEIVED WITH THE PLUNGER ROD PARTIALLY ADVANCED. THE CARTRIDGE WAS INSPECTED AND VISCOELASTIC RESIDUE WAS DISTRIBUTED THROUGH THE LENGTH OF THE CARTRIDGE. A MATERIAL APPEARED TO BE IN THE CARTRIDGE WHERE THE CARTRIDGE TIP MEETS THE CARTRIDGE TUBE. THE LENS WAS RECEIVED COATED IN VISCOELASTIC RESIDUE AND THE LENS WAS TORN, WITH A PIECE THAT WAS LOOSE; A HAPTIC WAS DETACHED. FURTHER ANALYSIS OF THE MATERIAL LODGED IN THE CARTRIDGE REVEALED THAT IT WAS A METHACRYLATE SPECIES, AND WAS FOUND SPECTRALLY IDENTICAL TO A REFERENCE JOHNSON & JOHNSON INTRAOCULAR LENS MATERIAL. THE FOURIER TRANSFORM INFRARED (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; HOWEVER, BASED ON THE COMPLAINT INVESTIGATION RESULTS THE COMPLAINT ISSUE COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. THE OTHER OBSERVED ISSUES COULD NOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING OR DESIGN ISSUE. 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: BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION 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 THERE WAS A FOREIGN MATERIAL IN THE INJECTOR OF THE PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL). THE LENS WAS NOT USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A REPLACEMENT DEVICE. THROUGH FOLLOW-UP, WE LEARNED THAT THE CARTRIDGE, IOL, AND FOREIGN MATERIAL WERE IN CONTACT WITH THE PATIENT'S EYE. 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
    1559746 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00V 05050474636781

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown