BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 23174050 · Received September 29, 2025

    Report

    Report Number
    3012236936-2025-000253
    Event Type
    Malfunction
    Date Received
    September 29, 2025
    Date of Event
    September 8, 2025
    Report Date
    December 1, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION B5 - DESCRIBE EVENT OR PROBLEM: ADDITIONAL INFORMATION WAS MADE AVAILABLE AND IT WAS LEARNED THAT BALANCED SALT SOLUTION WAS USED FOR THE PRELOADED DEVICE SETTING. 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: NOVEMBER 03, 2025. SECTION H3, DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: VISUAL INSPECTION REVEALED THAT THE HANDPIECE WAS RECEIVED WITH THE PLUNGER ROD FULLY ADVANCED. VISCOELASTIC RESIDUE WAS OBSERVED THROUGHOUT THE CARTRIDGE. NO ISSUES WERE OBSERVED WITH THE CARTRIDGE, LENS MODULE, DEVICE ASSEMBLY, OR PLUNGER ROD ADVANCEMENT. A BLACK MATERIAL WAS OBSERVED ON THE PLUNGER ROD. THE HANDPIECE WAS FORWARDED FOR FURTHER ANALYSIS. THE MATERIAL WAS FOUND TO BE METALLIC, LIKELY FERRITIC STAINLESS STEEL. COMPARISON AGAINST THE MANUFACTURING LIBRARY WAS NOT PERFORMED AS NO VALUABLE SPECTRUM COULD BE OBTAINED; A SCANNING ELECTRON MICROSCOPE (SEM) ANALYSIS WAS PERFORMED. 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. CONCLUSION: BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION COULD BE IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A3B, A4, AND A5: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION D6B - EXPLANT DATE: NOT APPLICABLE, AS LENS REMAINS IMPLANTED. SECTION E1 - EMAIL ADDRESS: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. 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 DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF RECORDS INCLUDING DEVICE HISTORY AND COMPLAINT TRENDING WILL BE PERFORMED. UPON COMPLETION OF THIS 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 A BLACK FOREIGN MATERIAL WAS FOUND IN THE INJECTOR OF THE MONOFOCAL PRELOADED INTRAOCULAR LENS (IOL) AFTER THE IOL WAS IMPLANTED. THE DOCTOR SAID THAT IT IS UNCLEAR WHETHER THE FOREIGN MATERIAL WAS ORIGINALLY INSIDE THE INJECTOR OR IF IT IS FROM BEFORE OR AFTER THE VISCOELASTIC WAS FILLED. NO PATIENT INJURY WAS REPORTED. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1525346 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00V

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female