MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; INTRAOCULAR LENS

Model Number	ZCU225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	06/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The zcu225 model intraocular lens (iol) was implanted in the patient¿s ocular sinister (left eye).Due to patient preference to change from a toric to a multi-focal lens, the iol was explanted in a secondary surgical procedure and replaced with a drt225 19.0 iol.There was no medical intervention, no patient injury, and no surgical intervention during the lens exchange procedure.Patient prognosis post lens exchange procedure is unknown.No further information is available.
Additional Manufacturer Narrative
Additional information: section a-3b patient gender: female section b-3 date of event: unknown/asked information was not provided.The best date estimation is between 04-jun-2025 and 18-jun-2025 (iol implant and explant dates).Section h-3 device evaluated by manufacturer: the complaint 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 report will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: 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 ; 7142478552
• MDR Report Key: 22487654
• Report Number: 3012236936-2025-000192
• Device Sequence Number: 20971154
• Product Code: HQL
• UDI-Device Identifier: 05050474658950
• UDI-Public: (01)05050474658950(17)280814
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/11/2025

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: ZCU225
• Device Catalogue Number: ZCU225U190
• 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: 06/18/2025
• Initial Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2023
• 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: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White