MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC ELLIPS FX PHACO HANDPIECE; UNIT, PHACOFRAGMENTATION

Model Number	690880
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	06/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2, a3, a4 and a5: unknown/ not provided.Section d6a: if implanted, give date: not applicable, as the system is not an implantable device.Section d6b: if explanted, give date: not applicable, as the system is not an implantable device.Device evaluation: the field service engineer visited the account and checked the product.The handpiece was tested, and its impedance, voltage measurements, and overall performance were determined to be within the manufacturer's specifications.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Event or Problem Description
The customer reported a corneal burn that necessitated three sutures, attributing the injury to an issue with the flow of irrigation during the use of the handpiece.The customer also indicated that no additional patient intervention or injury was associated with the incident.This report is for the ellips fx phaco handpiece.Separate reports will be submitted for other products used during the event.
Additional Manufacturer Narrative
Section h11.Additional data: the customer was able to complete the procedure in same visit.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

• Brand Name: ELLIPS FX PHACO HANDPIECE
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 22578614
• Report Number: 3012236936-2025-000200
• Device Sequence Number: 21168938
• Product Code: HQC
• UDI-Device Identifier: 05050474537132
• UDI-Public: (01)05050474537132
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K981116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2025

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: 690880
• Device Catalogue Number: 690880
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VERITAS SYSTEM, PHACO TIP, PHACO TUBING.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown