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 Code	Visual Disturbances (2140)
Date of Event	12/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent bilateral implantation of preloaded multifocal intraocular lenses (iols), models dxw150 and drt225.Following implantation, the patient experienced intolerance to the multifocal intraocular lenses.As a result, both lenses were explanted during secondary surgical procedures.The replacement lens for the patient's right eye was a different model with the same diopter power, det300u285 (sn (b)(6)).The replacement lens for the patient's left eye was a different model with a 0.5 diopter difference, det150u285 (sn (b)(6)).The patient reported difficulty reading medication labels, viewing her phone, and reading expiration dates on food packaging.No incision enlargement, sutures, vitrectomy, or procedure delays were reported.The patient's outcome status was reported as unknown.The patient's preoperative refraction prior to the original surgery was +2.75 -0.75 x 076 in the right eye and +2.25 -0.50 x 040 in the left eye, with a target postoperative refraction of plano in both eyes.The postoperative refraction was reported as +1.00 -1.50 x 100 in the right eye and plano -0.75 x 150 in the left eye.The directions for use (dfu) were followed, and no additional medical treatment or medications beyond standard postoperative care were required.No additional information was provided.This report pertains to patient's left eye.A separate report will be submitted for the patient's right eye.
Additional Manufacturer Narrative
Section h6: health effect-impact code:4619- temporary impairment (dysphotopsia- requiring surgical intervention) 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.

• 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: 50203038
• Report Number: 3012236936-2026-000235
• Device Sequence Number: 5545848
• Product Code: MFK
• UDI-Device Identifier: 05050474812109
• UDI-Public: (01)05050474812109(17)280117
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 09/08/2026

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: DRT2250280
• 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: 07/14/2026
• Supplement Date Received by Manufacturer: 08/14/2026
• Initial Report FDA Received Date: 08/11/2026
• Supplement Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2025
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 138 LB
• Patient Race: White