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	Blurred Vision (2137); Visual Impairment (2138); Halo (2227)
Date of Event	04/13/2026
Type of Reportable Event	Serious Injury
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 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a multifocal toric intraocular lens (iol) was explanted from the patient¿s left eye due to an off-target outcome.The patient had a pre-existing condition of narrow angles.Following implantation, the patient experienced intense halos, suboptimal distance vision, and described the vision as soft and blurry at almost all ranges.The account suggested that the device may have contributed to the reported event.Preoperative refraction was +7.00 -1.25 x011, with a preoperative best spectacle corrected visual acuity (bscva) of 20/15-1.The intended target refraction was plano sphere (pl sph).Postoperative refraction was reported as -0.75 -1.25 x127, and postoperative bscva was 20/15-1.The patient was reported to be overcorrected and experienced a loss of two or more lines of bscva.The affected lens was explanted and replaced with a lens of the same model having a lower diopter power (30.0d).No unplanned surgical interventions, including vitrectomy, incision enlargement, or suture placement, were required.No medications outside the standard of care were prescribed, and no additional surgical interventions were planned.At the time of follow-up, the patient reported no complaints of halos or distance vision issues and was satisfied with the visual outcome.The post-exchange refraction was not yet available.No further 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: 25817785
• Report Number: 3012236936-2026-000205
• Device Sequence Number: 10699722
• Product Code: MFK
• UDI-Device Identifier: 05050474812178
• UDI-Public: (01)05050474812178(17)270715
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 07/14/2026

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: DRT2250315
• 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: 06/19/2026
• Initial Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2024
• 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: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White