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

Model Number	CATALYS-U
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Prolapse (2475)
Date of Event	07/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on the last patient, in the operating room once the cataract was completely removed, the intraocular lens (iol) was in place, and surgeon was performing the final irrigation and aspiration (i/a) clean up when the patient violently moved which led to iris prolapse and the need for miostat and sutures to close the wound on the left eye.The surgeon confirmed that the incident was not related to the laser procedure but reported it in accordance with protocol.Postoperative assessment of the patient is ongoing, and the surgeon is determining the next steps.No additional information was provided.
Additional Manufacturer Narrative
Section a4 and a5: unknown/ not provided.Section d6a: if implanted, give date: not applicable, as the device is not an implantable.Section d6b: if explanted, give date: not applicable, as the device is not an implantable.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 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.Note: this report was impacted by emdr scheduled maintenance occurring july 22-27, 2026.

• 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: 50027545
• Report Number: 3012236936-2026-000223
• Device Sequence Number: 16089842
• Product Code: OOE
• UDI-Device Identifier: 05050474609792
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K113479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/24/2026

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: 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: 07/01/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2014
• 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: Required Intervention
• Patient Sex: Male
• Patient Race: White