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 Code	Halo (2227)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the preloaded johnson and johnson (jnj) multifocal intraocular lens (iol) was implanted into the patient¿s right eye.The patient reported experiencing visual disturbances, specifically severe halos or rings around lights, which began immediately after the implant.She raised concerns about driving safety and noted that her doctor had informed her of the potential for such symptoms but had not anticipated their severity.The patient called back later to report that the iol was explanted because she could not tolerate the halos and had difficulty driving.Johnson and johnson followed up with the doctor¿s office.The doctor involved is dr.(b)(6).They confirmed the iol was explanted and replaced with a non jnj monofocal lens 21.5 diopter.The doctor¿s office explained that the patient was not a good candidate for a multifocal lens to begin with, but the patient was adamant about trying them.The patient experienced halos and never neuro adapted.During the original procedures and the explant there were no complications such as a capsule tear, vitrectomy, or sutures.The explanted iol was likely discarded.No further information is available.
Additional Manufacturer Narrative
Section a4, patient weight: unknown/not provided.Section a5, ethnicity: unknown/not provided.Section a6, race: unknown/not provided.Section b3, date of event: the exact date is unknown.The best estimate is between the implant and explant dates, on (b)(6) 2025 through on (b)(6) 2026.Section h3, device evaluated by manufacturer: 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 the device history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempt was made to obtain the missing information.However, to date, it has not been received.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 ; 7142478552
• MDR Report Key: 24677224
• Report Number: 3012236936-2026-000075
• Device Sequence Number: 10331641
• Product Code: MFK
• UDI-Device Identifier: 05050474810792
• UDI-Public: (01)05050474810792(17)270903
• Combination Product (Y/N): N
• 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: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

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 Model Number: DRN00V
• Device Catalogue Number: DRN00V0215
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2024
• 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