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	Posterior Capsule Opacification (4807)
Date of Event	01/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a single-piece preloaded multifocal intraocular lens (iol) in the patient¿s right eye developed posterior capsule opacification (pco).The event was identified during a postoperative examination.The pco was treated with a yag laser capsulotomy prior to the patient¿s enrollment in the study.The iol remains implanted, and no patient harm was reported.Additional information indicated that the preoperative refraction was +2.25 -0.50 × 090, and the postoperative refraction was +0.25 -0.25 × 180.Both preoperative and postoperative bscva were 20/20.It was unknown whether the patient lost any lines of visual acuity.It was also unknown whether the patient was over- or under-corrected, and the intended refractive target was not provided.No pre-existing conditions affecting iol power calculation were reported.The patient¿s daily activities were not affected.No unplanned surgical interventions such as incision enlargement, sutures, or vitrectomy were required.No medications outside the standard of care were prescribed.The final patient outcome was not reported.No further information was provided.
Additional Manufacturer Narrative
Section d6b: if explanted, give date: not applicable, as lens remains implanted.Section h3: the device was not returned for evaluation as it remains implanted; 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 were made to obtain the missing information; however, no additional information has 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: 24564897
• Report Number: 3012236936-2026-000061
• Device Sequence Number: 8860314
• Product Code: MFK
• UDI-Device Identifier: 05050474810846
• UDI-Public: (01)05050474810846(17)260507
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/10/2026

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 Expiration Date: 05/07/2026
• Device Model Number: DRN00V
• Device Catalogue Number: DRN00V0240
• 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: 02/13/2026
• Initial Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2023
• 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: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White