MAUDE Adverse Event Report: AMO Manufacturing Netherlands TECNIS IOL; Extended Depth Of Focus Intraocular Lens

Model Number	ZXR00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Flashers (1864); Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Event or Problem Description
This report is to capture the right eye.It was reported that a johnson and johnson (jnj) intraocular lens (iol) was implanted in the patient¿s left and right eye.The patient reported blurry vision.In their right eye the patient experienced starbursts and had post-operative laser surgery.In their left eye they see soft halos.The patient takes thera tears for her dry eyes.She has a doctor¿s appointment and plans on contacting us after her visit.The patient wants to know if this iol was ever recalled.No further information was provided.
Additional Manufacturer Narrative
Section d6b, if explanted, give date: not applicable as the iol remains implanted.Section h3, device evaluated by manufacturer: 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 the device history record and complaint trending for this device 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 to obtain the missing information.However, to date, it has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: Extended Depth Of Focus Intraocular Lens
• 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: 50438853
• Report Number: 3012236936-2026-000233
• Device Sequence Number: 18438236
• Product Code: POE
• UDI-Device Identifier: 05050474591769
• UDI-Public: (01)05050474591769(17)230321
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/25/2026

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: 03/21/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0285
• 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: 08/03/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2018
• 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