MAUDE Adverse Event Report: AMO Manufacturing Netherlands TECNIS Odyssey Toric II IOL; Lens, Multifocal Intraocular

Model Number	DRT225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227)
Date of Event	01/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient implanted bilaterally with multifocal toric intraocular lenses (iols) experienced poor quality of vision, intolerable halos, and glare following implantation and was unable to drive at night.Visual symptoms were first identified during post-operative examinations.Pre-operative bscva was reported as 20/25 in the right eye and 20/20 in the left eye, while post-operative bscva was 20/20 in both eyes.Due to difficulty adapting to the lenses, the lenses in both eyes were explanted.The replacement lenses were non-johnson & johnson lenses with a power of 17.0 diopters.No capsule tear occurred, and no unplanned medical or surgical interventions, including vitrectomy, incision enlargement, sutures, or medications outside the standard of care, were required.No pre-existing conditions were reported.The patient outcome was reported as doing well following surgery; however, the patient still requires lens adjustment with praxis.The customer indicated that the directions for use were followed.No further information was provided.This report pertains to the patient's left eye.A separate report is being submitted to document the event associated with the patient's right eye.
Additional Manufacturer Narrative
Section h3: the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Section h6: health effect - impact code: 4619 - temporary impairment (this code is used for the reported halo vision- surgical intervention required & glare surgical intervention required) all pertinent information available to johnson & 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 ; +1(714)247-8552
• MDR Report Key: 50105623
• Report Number: 3012236936-2026-000227
• Device Sequence Number: 5306479
• Product Code: MFK
• UDI-Device Identifier: 05050474811898
• UDI-Public: (01)05050474811898(17)280128
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: DRT225
• Device Catalogue Number: DRT2250175
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/31/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2026
• Supplement Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 07/31/2026
• Supplement Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 186 LB
• Patient Race: White