BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 24335244 · Received February 13, 2026

    Report

    Report Number
    3012236936-2026-000041
    Event Type
    Malfunction
    Date Received
    February 13, 2026
    Report Date
    March 20, 2026
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    MFK
    UDI-DI
    05050474810730
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RECEIVED FOR EVALUATION. DEVICE EVALUATION: VISUAL INSPECTION REVEALED THAT THE CARTRIDGE TIP WAS DAMAGED. OVD WAS OBSERVED INSIDE THE CARTRIDGE. THE LENS MODULE, PLUNGER ROD, AND HANDPIECE WERE INSPECTED, AND NO ISSUES WERE OBSERVED. THE LENS WAS VISUALLY INSPECTED REVEALING THAT THE LENS WAS DAMAGED ON THE EDGE. NO FURTHER ISSUES WERE IDENTIFIED. THE COMPLAINT ISSUE "LENS DAMAGED" 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 DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING OR DESIGN ISSUE. CONCLUSION: BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION COULD BE IDENTIFIED. THE FOLLOWING FIELDS WERE UPDATED ACCORDINGLY: SECTION D9: DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9: DATE RETURNED TO MANUFACTURER: FEB 10, 2026. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION B3: DATE OF EVENT: UNKNOWN/NOT PROVIDED. THE BEST ESTIMATE OF THE DATE OF EVENT IS PRIOR TO JAN 22, 2026. SECTION D6A: IF IMPLANTED, GIVE DATE: UNKNOWN/NOT PROVIDED; THE EXTENT OF PATIENT CONTACT IS UNKNOWN, HOWEVER THERE IS NO INDICATION THAT THE LENS WAS FULLY IMPLANTED. SECTION D6B: IF EXPLANTED, GIVE DATE: UNKNOWN/NOT PROVIDED; THE EXTENT OF PATIENT CONTACT IS UNKNOWN, HOWEVER THERE IS NO INDICATION THAT THE LENS WAS FULLY IMPLANTED, THEREFORE, NOT EXPLANTED. ATTEMPTS WERE MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN IMPLANTATION OF A SINGLE PIECE PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), THE DOCTOR NOTICED THAT IT WAS CRACKED. THE EVENT WAS OBSERVED DURING THE DELIVERY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396111 TECNIS SIMPLICITY LENS, MULTIFOCAL INTRAOCULAR MFK AMO MANUFACTURING NETHERLANDS DRN00V 05050474810730

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown