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

Model Number	DRT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Halo (2227)
Date of Event	03/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a multifocal toric intraocular lens (iol) was explanted from the patient's right eye due to suboptimal vision.Prior to explantation, the patient experienced difficulty with both distance and near vision and was unable to drive at night due to halos.The patient experienced a loss of two or more lines of best spectacle-corrected visual acuity (bscva), decreasing from a preoperative bscva of 20/25 to a postoperative bscva of 20/40.Preoperative refraction was reported as -2.75 +1.25 x 180, and postoperative refraction was -1.50 sphere, with an intended target refraction of plano.The patient was not reported to be over-corrected or under-corrected.A history of previous lasik surgery was reported.The lens was replaced with a non-johnson & johnson lens of lower diopter power (17.0d).No patient injury, such as a capsule tear, was reported.No medical intervention, including vitrectomy, sutures, incision enlargement, or medications outside the standard of care, was required, and no planned surgical interventions were reported.The procedure was completed successfully, and the patient was reported to be doing well.The customer indicated that the device did not cause or contribute to the reported event.The product was not returned for evaluation because it was discarded.No further information was provided.
Additional Manufacturer Narrative
Section a5: ethnicity: unknown, information was requested but not provided.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 this review, if there is any further relevant information, a supplemental medwatch will be filed.Section h6: health effect - clinical code: 2138 - unexpected postop refraction; 2138 - vision loss (nos).Attempts were made to obtain additional information regarding the event; however, the information was not 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: 50104691
• Report Number: 3012236936-2026-000227
• Device Sequence Number: 21351451
• Product Code: MFK
• UDI-Device Identifier: 05050474811300
• UDI-Public: (01)05050474811300(17)270625
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2026

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: DRT150
• Device Catalogue Number: DRT1500175
• Was Device Available for Evaluation?: No
• 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: 07/07/2026
• Initial Report FDA Received Date: 07/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 160 LB
• Patient Race: White