MAUDE Adverse Event Report: AMO Manufacturing Netherlands TECNIS IOL; Lens, Intraocular, Toric Optics

Model Number	ZXW225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Posterior Capsule Opacification (4807)
Date of Event	01/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a postoperative examination, the patient implanted with an extended depth of focus (edof) intraocular lens (iol) underwent bilateral yag laser posterior capsulotomy to treat grade 2+ posterior capsule opacification (pco) in both eyes.The procedure was reported to be successful, and no additional surgical intervention was required.The affected product is not expected to be returned for evaluation.No further information was provided.This report pertains to the right eye (od).A separate report will be submitted for the left eye (os).
Additional Manufacturer Narrative
Section a2: date of birth, age: unknown/not provided section a3a, a3b: sex, gender: unknown/not provided section a4: weight: unknown/not provided section a5: ethnicity: unknown/not provided section a6: race: unknown/not provided section d6a.If implanted, give date: unknown, information not provided.Section d6b.If explanted, give date: unknown, information not provided.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 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 IOL
• Common Device Name: Lens, Intraocular, Toric Optics
• 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: 50202409
• Report Number: 3012236936-2026-000235
• Device Sequence Number: 10436513
• Product Code: MJP
• UDI-Device Identifier: 05050474732971
• UDI-Public: (01)05050474732971(17)251013
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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: 10/13/2025
• Device Model Number: ZXW225
• Device Catalogue Number: ZXW225U215
• 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: 07/14/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2020
• 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: Unknown