MAUDE Adverse Event Report: AMO Manufacturing Netherlands TECNIS SIMPLICITY; Lens, Multifocal Intraocular

Model Number	DRN00V
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	05/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a lens exchange was performed in the right eye of a patient.The implanted preloaded multifocal intraocular lens (iol) was explanted due to the patient's complaint of halos while driving at night, which significantly interfered with daily activities.The lens was exchanged with a den00v +20.5d iol.The patient's pre-operative visual acuity was reported as 20/25, and the post-operative visual acuity was reported as 20/40 at one day post-operatively.No patient injury was reported.No medical or surgical interventions associated with the event were reported, and no future interventions were planned.The patient was reported to be doing well post-operatively following the lens exchange.The explanted lens was discarded and, therefore, is not available for evaluation.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.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.

• Brand Name: TECNIS SIMPLICITY
• 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: 50437548
• Report Number: 3012236936-2026-000251
• Device Sequence Number: 8827290
• Product Code: MFK
• UDI-Device Identifier: 05050474810792
• UDI-Public: (01)05050474810792(17)271120
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2026

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: DRN00V
• Device Catalogue Number: DRN00V0215
• 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: 07/31/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2024
• 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: Female
• Patient Weight: 135 LB
• Patient Race: White