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

Model Number	ZXW150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Posterior Capsule Opacification (4807)
Date of Event	03/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a non-preloaded multifocal intraocular lens (iol) was implanted in the patient's right eye.During a postoperative examination, 3+ posterior capsular opacification (pco) was observed and was successfully treated with a yag capsulotomy.No additional intervention was required.The complaint device remains implanted.No further information was provided.
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5 and a6: unknown, information was requested but not provided.Section d6a: implant date unknown/not provided.Section d6b: if explanted; give date: n/a (not applicable).The intraocular 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.Section h6: health effect-impact code:4625-additional surgery (yag : surgical intervention).Attempts 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.

• 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: 50202795
• Report Number: 3012236936-2026-000235
• Device Sequence Number: 12136746
• Product Code: MJP
• UDI-Device Identifier: 05050474732384
• UDI-Public: (01)05050474732384(17)251012
• 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: Non-Healthcare 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: 10/12/2025
• Device Model Number: ZXW150
• Device Catalogue Number: ZXW150U215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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: 10/12/2020
• 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