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

Model Number	0160-6020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	08/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During surgery performed with the catalys system on (b)(6) 2026, the patient experienced a stromal extrusion at the primary incision of the left eye (os).The issue was identified at a postoperative visit on (b)(6) 2026, and a bandage contact lens was applied.No further information was provided.
Additional Manufacturer Narrative
Section 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: the 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 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 ; 510 cottonwood drive; milpitas, CA 95035 ; +1(714)247-8552
• MDR Report Key: 50872135
• Report Number: 3012236936-2026-000278
• Device Sequence Number: 9379810
• Product Code: OOE
• UDI-Device Identifier: 05050474617186
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K172002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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 Model Number: 0160-6020
• Device Catalogue Number: 0160-6020
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Female