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

Model Number	DRT300
Medical Device Problem Codes	Break (1069); Device Difficult to Setup or Prepare (1487); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the preloaded toric intraocular lens (iol) was pushed into the cartridge the leading haptic was twisted while the trailing haptic was slightly bent, and abnormal tacking was observed.The haptics adhered to the optic, and it took more than five minutes to separate the haptics from the optic using a hook or a similar instrument.The plunger did not readily separate from the iol.The patient's postoperative visual acuity was reported as good.The injector had been set up immediately prior to implantation; ophthalmic viscoelastic device (ovd) was injected through the hydration port and the plunger was advanced at a normal speed without issue.After setup, the iol was inserted into the eye without waiting.Through follow-up, we learned that the iol was implanted in the patient's right eye and no medical complications occurred.No further information was provided.
Additional Manufacturer Narrative
Section a2, a3, a4, and a5: unknown, as information was requested but not provided.Section d6b - explant date: not applicable - lens remains implanted; therefore, not explanted.Section e1: email address: unknown, as information was requested but not provided section e1: telephone number: (b)(6).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.

• 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: 23796924
• Report Number: 3012236936-2025-000318
• Device Sequence Number: 14881291
• Product Code: MFK
• UDI-Device Identifier: 05050474812277
• UDI-Public: (01)05050474812277(17)280204
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/13/2025

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: DRT300
• Device Catalogue Number: DRT3000070
• 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: 11/17/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2025
• 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 Sex: Unknown