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	Blurred Vision (2137)
Date of Event	12/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a preloaded multifocal toric intraocular lens (iol) was explanted from the patient¿s right eye because the patient was unable to adapt to the implant and experienced blurry vision.No harm to the patient or user was reported.No further information was provided.
Additional Manufacturer Narrative
Section a4 and a5: unknown, information was requested but not provided.Section d6b.If explanted, give date: unknown, information not provided.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: 4619 - this code was used to capture the impact of blurry vision.An attempt 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.
Additional Manufacturer Narrative
Additional information: the following fields were updated accordingly based on the additional information received: section a4: weight: 140 lbs.Section a5: ethnicity: other.Section a6: race: other.Section b5: additional information received indicated that the patient had difficulty driving and seeing up close before the explant.There was no loss of 2 or more lines of bscva (best spectacle corrected visual acuity).The replacement lens was another toric lens of different model, zcu225 of the same diopter (25.0d) as the original lens.The account suggests that the device caused or contributed to the event.No unplanned medical or surgical interventions such as vitrectomy, incision enlargement or sutures required.The patient's post op refraction after the lens exchange is unknown, however, the outcome status was reported as improved.The device is not available for return and evaluation as it was cut out and put in biohazard.Section b7: fuch¿s dystrophy.Section d6b.If explanted, give date: (b)(6) 2025.Section h6: type of investigation: 4115 - device discarded.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 ; 7142478552
• MDR Report Key: 24032093
• Report Number: 3012236936-2026-000013
• Device Sequence Number: 21096849
• Product Code: MFK
• UDI-Device Identifier: 05050474812048
• UDI-Public: (01)05050474812048(17)270930
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: 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): 02/05/2026

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: DRT2250250
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2024
• 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 Age: 27 YR
• Patient Sex: Male
• Patient Weight: 64 KG