BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 23410389 · Received October 28, 2025

    Report

    Report Number
    3012236936-2025-000270
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    October 3, 2025
    Report Date
    December 2, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474739406
    PMA / PMN Number
    P980040
    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 LENS WAS REMOVED/REPLACED DURING THE SAME PROCEDURE. SECTION D6B: IF EXPLANTED, GIVE DATE: N/A, AS LENS WAS REMOVED/REPLACED DURING THE SAME PROCEDURE. SECTION E1 - TELEPHONE NUMBER: (B)(6). SECTION G4: PMA/510(K) NUMBER: THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS OPTIBLUE SIMPLICITY PRELOADED 1-PIECE IOL, MODEL DIB00V THAT HAS A SIMILAR DEVICE, TECNIS SIMPLICITY PRELOADED 1-PIECE IOL MODEL DIB00 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9, DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9, DATE RETURNED TO MANUFACTURER: OCTOBER 28, 2025. SECTION H3, DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION WAS PERFORMED ON THE SUSPECT PRODUCT. THE PLUNGER ROD WAS FOUND FULLY ADVANCED WITH VISCOELASTIC RESIDUE OBSERVED THROUGHOUT THE CARTRIDGE. STRESS MARKS WERE OBSERVED ON THE CARTRIDGE TIP BUT WERE IN SPECIFICATION FOR A USED DEVICE. NO ISSUES WERE IDENTIFIED WITH THE LENS MODULE, DEVICE ASSEMBLY, OR PLUNGER ROD ADVANCEMENT. THE PLUNGER ROD TIP WAS OBSERVED TO BE SLIGHTLY BENT. THE LENS WAS RECEIVED COATED IN VISCOELASTIC RESIDUE AND WHAT APPEARS TO BE BLOOD. THE LENS WAS CLEANED REVEALING THAT THE LENS WAS CUT AND SCRATCHED. NO FURTHER EVALUATION WAS PERFORMED. THE COMPLAINT ISSUE "COSMETIC ISSUES" 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 COMPLAINT ISSUE "DIFFICULT TO USE" WAS NOT IDENTIFIED. CONCLUSION: BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION COULD BE FOUND. 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 SCRATCH WAS FOUND IN THE CENTER OF THE PRELOADED INTRAOCULAR LENS (IOL) AFTER INSERTION, LEADING TO THE REMOVAL OF THE IOL AND THE INSERTION OF THE REPLACEMENT LENS. THE PHYSICIAN FELT SOME RESISTANCE DURING LENS INSERTION OF THE INITIAL IOL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2546426 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00V 05050474739406

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown