MAUDE Adverse Event Report: AMO Manufacturing USA, LLC CATALYS SYSTEM; Ophthalmic Femtosecond Laser

Model Number	CATALYS-U
Medical Device Problem Codes	Computer Software Problem (1112); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that during laser treatment on the 3rd patient, although the doctor¿s foot remained on the footswitch and the laser was firing, the system displayed the message "laser footswitch lifted during treatment." the issue occurred toward the end of the procedure, and before the doctor could press the footswitch again, the treatment was aborted; therefore, the third procedure was not completed.No patient injury was reported.
Additional Manufacturer Narrative
Section a2, a3, a4, a5 and a6: unknown/ not provided.Section d6a: if implanted, give date: not applicable, as the device is not an implantable device.Section d6b: if explanted, give date: not applicable, as the device is not an implantable device.Section h3: customer replaced footswitch on their own and no additional complications have been observed on the system.Customer instructed to monitor and report if additional problems arise.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.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

• Brand Name: CATALYS SYSTEM
• Common Device Name: Ophthalmic Femtosecond Laser
• Manufacturer (Section D): AMO Manufacturing USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; +1(714)247-8552
• MDR Report Key: 50942863
• Report Number: 3012236936-2026-000287
• Device Sequence Number: 10429041
• Product Code: OOE
• UDI-Device Identifier: 05050474609792
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K113479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CATALYS-U
• Device Catalogue Number: CATALYS-U
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2017
• 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
• Patient Sex: Unknown