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); Decrease in Suction (1146)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported multiple "possible fluid loss" system warnings during laser fragmentation followed by loss of vacuum; surgeon aborted the procedure.Physician completed cataract removal and intraocular lens (iol) implantation in the operating room without complications or need for further procedures.No further information provided.
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 implantable.Section d6b: if explanted, give date: not applicable, as the device is not implantable.Section h3: the device was not returned; therefore, a failure analysis of the complaint device cannot be completed.A review of records including device history record 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 ; 7142478552
• MDR Report Key: 24771840
• Report Number: 3012236936-2026-000084
• Device Sequence Number: 10299069
• Product Code: OOE
• UDI-Device Identifier: 05050474609792
• UDI-Public: (01)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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2026

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
• 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: 03/10/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2017
• 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: LIQUID OPTICAL INTERFACE.
• Patient Sex: Unknown