MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS ODYSSEY TORIC II IOL; LENS, MULTIFOCAL INTRAOCULAR

Model Number	DRT150
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d6a: not applicable, as the lens was not implanted.Section d6b: not applicable, as the lens was not implanted, hence not explanted.Section h3:the device was not returned for evaluation as it was discarded 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 the review, if there is any further relevant information a supplemental medwatch will be filed.An attempts has been made to obtain missing information; however, the information has not been provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that during implantation of the preloaded multifocal intraocular lens (iol), model drt150, into the patient¿s right eye, resistance was encountered during lens advancement, resulting in the lens tearing.Patient contact occurred.Additional information confirmed that the lens was partially delivered, and no additional surgical maneuvers beyond standard technique were required to facilitate lens delivery and positioning.The procedure was completed successfully using a replacement lens of the same model and diopter.No patient injury was reported, and no unplanned medical or surgical interventions (such as vitrectomy, incision enlargement, or suturing) were required.The current patient outcome is reported as doing well.The stablevisc ophthalmic viscosurgical device (ovd) was used to fill the cartridge prior to lens loading at room temperature.The cartridge was prepared with balanced salt solution (bss) or ovd via the hydration port.One twist of the injector knob was performed to advance the lens into the cartridge, and an additional twist was completed prior to handing the handpiece to the surgeon.The lens remained in the cartridge for no longer than two minutes before use.It was reported that the surgeon initially advanced the lens into the cartridge; however, it is unknown whether resistance was encountered at that stage.The complaint device was discarded.No additional information was provided.

• Brand Name: TECNIS ODYSSEY TORIC II IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 25356476
• Report Number: 3012236936-2026-000159
• Device Sequence Number: 15914428
• Product Code: MFK
• UDI-Device Identifier: 05050474811379
• UDI-Public: (01)05050474811379(17)271119
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DRT150
• Device Catalogue Number: DRT1500210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Hispanic
• Patient Race: White