MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC CATALYS SYSTEM; OPHTHALMIC FEMTOSECOND LASER

Model Number	CATALYS-U
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	11/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported an incident that occurred in 2024, "dr.(b)(6) patient unhappy with right eye surgery", the record was not available in the system following a database reset.Post-operative event was reported, the patient returned to the operating room on (b)(6) 2024 for removal of residual lens fragments.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 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.
Additional Manufacturer Narrative
Corrected data: based on further review of the complaint file, it was noted that an incorrect date (nov 5, 2014) was inadvertently entered in section "h4 - device manufacturer date" of the initial medwatch report.This supplement is being submitted to correct that information.The following section has been updated accordingly: section h4: nov 6, 2014.Additional information: product evaluation was performed for this incident.No malfunctions were found during evaluation.Manufacturing deficiency was not identified.System met all specifications prior to release.Service deficiency was not identified.Design deficiency was not identified.No user/usage deficiency identified.Assessments of manufacturing, service, design, and usage were completed, and system was evaluated and is performing to specification.Reviews of labeling and risk management files were conducted, and no new issues/risks were identified.Johnson & johnson surgical vision will continue to monitor these types of complaints.The reported issue is an anticipated/expected event for catalys-u and does not represent a new risk.Based on the last annual risk management review and ongoing post-market surveillance activities, the probability of occurrence for the reported event remains within the rates established in the product risk management files.No new issues/risks were identified as part of this investigation.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
Additional Manufacturer Narrative
Corrected data: based on further review of the complaint file, it was noted that an incorrect date was inadvertently entered in section "section b3.Event date" of the initial medwatch report.This supplement is being submitted to correct that information.The following section has been updated accordingly: section b3: nov 8, 2024.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: 24255725
• Report Number: 3012236936-2026-000033
• Device Sequence Number: 18243514
• Product Code: OOE
• UDI-Device Identifier: 05050474609792
• UDI-Public: (01)05050474609792
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,Followup
• Report Date (Section B): 04/17/2026

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
• 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: 01/09/2026
• Supplement Date Received by Manufacturer: 02/19/2026; 03/18/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/11/2026; 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2014
• 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: Unknown