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 Disturbances (2140); Discomfort (2330)
Date of Event	06/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4, a5 and a6: unknown, information was requested but not provided.Section b3: date of event: unknown, not provided, but the best estimate date is between may 12, 2025 and dec 12, 2025.Section d6b.If explanted, give date: unknown, information 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.
Event or Problem Description
It was reported that a preloaded multifocal intraocular lens (iol) was explanted from a patient's right eye as the patient was not happy with the lens and wanted it replaced.The intraocular lens will not be returned.No further information was provided.The patient underwent bilateral lens implantation.This report pertains to the right eye.A separate report will be submitted for the left eye.
Additional Manufacturer Narrative
Additional information: the following fields were updated accordingly based on the additional information received: section a4: weight: 128 lbs.Section a5: ethnicity: not hispanic/latino section a6: race: white all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: the following fields were updated based on the additional information received: section b3: date of event: 6/26/2025.Section b5: additional information received indicated that the reason for the explant was due to contrast loss and dysphotopsia.The replacement lens was a non-johnson & johnson lens of 21.0 diopter.It was noted that the device did not cause or contribute to the event.The patient was not under or over corrected.Pre-op refraction: +3.00 -0.25 @90.Pre-op best spectacle corrected visual acuity (bscva): 20/20.Post-op refraction: -0.25 -0.50 @90.Post-op bscva: 20/25.Intended target refraction: -0.28.The patient did not have any pre-existing condition.There were no unplanned surgical interventions such as vitrectomy, incision enlargement or sutures required.No medication outside the standard of care prescribed and there are no planned surgical interventions.The post op refraction after the lens exchange is -0.50 and the patient is happy with the lens exchange to the replacement lens.It was confirmed that the lens was discarded.Section d6b: if explanted, give date: 10/20/2025.The following codes were added based on the additional information received: section h6: health effect - impact code: 4619 - temporary impairment.Section h6: health effect - clinical code: 2140 - visual disturbances.Corrected data: the following codes are no longer applicable: section h6: health effect - impact code: 4613 - minor injury/ illness / impairment.Section h6: health effect - clinical code: 2330 - discomfort.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: 23992596
• Report Number: 3012236936-2026-000009
• Device Sequence Number: 10239669
• Product Code: MFK
• UDI-Device Identifier: 05050474810808
• UDI-Public: (01)05050474810808(17)270704
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2026

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: DRN00V0220
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 01/06/2026; 02/10/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/02/2026; 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/04/2024
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White