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	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227)
Date of Event	12/12/2024
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.Section h6: health effect- impact code 4613: minor injury/illness/ impairment: blurry vision (not impacting daily life activities).Section h6: health effect- impact code 4619: temporary impairment:(halo vision, hm-glare and visual disturbance- dysphotopsia).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.
Event or Problem Description
It was reported that a preloaded multifocal intraocular lens (iol), model drt150, was implanted in the patient¿s right eye.Postoperatively, the patient initially reported satisfactory vision; however, they subsequently experienced bothersome halos and difficulty reading materials with dark backgrounds.Additional information indicated that the lens ring design contributed to the halos and associated visual disturbances.As a result of these symptoms, the iol was explanted during a secondary surgical procedure and replaced with a different model and diopter (zcu150u210).Further information indicated that the patient¿s activities of daily living were not impacted.The patient was neither overcorrected nor undercorrected.Preoperative refraction was +2.00 -1.25 × 091, and postoperative refraction following the initial implantation was +0.50 -0.50 × 175, with an intended refractive target of plano.Best spectacle-corrected visual acuity (bscva) changed from 20/15 preoperatively to 20/20 postoperatively following the initial procedure.After the lens exchange, postoperative refraction was -0.25 sphere.There were no reports of unplanned surgical interventions (e.G., vitrectomy, incision enlargement, or suturing), and no medications outside the standard of care were required.The patient outcome following the lens exchange was reported as good.No additional 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: 25429230
• Report Number: 3012236936-2026-000169
• Device Sequence Number: 10284895
• Product Code: MFK
• UDI-Device Identifier: 05050474811379
• UDI-Public: (01)05050474811379(17)261003
• 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: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2026

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 Expiration Date: 10/03/2026
• Device Model Number: DRT150
• Device Catalogue Number: DRT1500210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/11/2026
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 06/08/2026
• Supplement Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2023
• 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: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White