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	Visual Impairment (2138)
Date of Event	01/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a preloaded multifocal intraocular lens (iol) was explanted from a patient's operative eye due to a hyperopic outcome and as the patient was dissatisfied with the initial result.The lens was replaced with another iol of the same model but higher diopter (19.5 d).The patient outcome was not provided.No further information was provided.
Additional Manufacturer Narrative
Section a4, a5 and a6: unknown, information was requested but not provided.Section b3: date of event: exact date unknown/not provided.Best estimate date is between (b)(6) 2026-(b)(6) 2026.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.Attempts have been made with the customer to obtain additional information, however, to date, the information has not been provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: additional information was received, and the following fields have been updated accordingly: section a6: race: white.Section b3: date of event: (b)(6) 2026.Section b5: additional information received indicated that the affected eye was the patient¿s right eye.It was confirmed that the device did not cause or contribute to the event.The issue was related to the need for a different/higher diopter lens selection for the patient.Prior to the explant, the patient was unable to read or drive comfortably.It was confirmed that there was no loss of two or more lines of best spectacle corrected visual acuity (bscva).The patient was under-corrected but not over-corrected, and there were no pre-existing conditions reported.During the explant procedure, no unplanned surgical interventions such as vitrectomy, incision enlargement, or sutures were required.No medication outside the standard of care was prescribed, and no additional surgical interventions are planned.Following the explant, the patient is reportedly seeing very well, with visual acuity of 20/25 without correction.Pre-op refraction: +1.50 diopters sphere (ds), pre-op bscva: 20/30-2, post-op refraction: +0.75 ds, post-op bscva: 20/20, intended target refraction: plano.Corrected data: upon further review of the event and based on the additional information received, noting that the originally implanted lens was 18.5 diopters (d) and the replacement lens was the same model with a higher diopter (19.5 d).It was determined and confirmed that the issue was related to the need for an different diopter calculation for patient use.Following explantation and implantation of the replacement lens, the patient reported good visual outcomes.Therefore, the event was not attributed to a product malfunction and no longer meets the reportable explant criteria.No further information will be provided under this manufacturer report number 3012236936-2026-0000616.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: 24527363
• Report Number: 3012236936-2026-000061
• Device Sequence Number: 8439602
• Product Code: MFK
• UDI-Device Identifier: 05050474810730
• UDI-Public: (01)05050474810730(17)280310
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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
• Report Date (Section B): 04/07/2026

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: DRN00V0185
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2025
• 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: Male
• Patient Race: White