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 Codes	Wound Dehiscence (1154); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2, a4 and a5: unknown/ not provided.Section d6a: if implanted, give date: not applicable, as the catalys system is not an implantable device.Section d6b: if explanted, give date: not applicable, as the catalys system is not an implantable device.Section h3: the catalys system was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device 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.
Event or Problem Description
Customer reported that they were initially unable to enter the side port incision after using the catalys system, then discovered that the eipert forcep was bent.Physician successfully entered side port with a sinski but was unable to find the incision with a cannula, so they used a 1.0 mm blade to open the incision.He opened the primary incision easily with a new eipert.At the end of the case, the primary incision leaked, necessitating sutures, which the physician attributed to a possible 'wound burn' from phaco (centurion).He also faced initial occlusion and foot pedal connection issues with the centurion phaco machine.Despite these challenges, the side port incision self-sealed, and the cataract surgery and iol implant were successfully completed without further surgical intervention or harm to the patient.The capsulotomy was completed and he liked the lens softening.Application support manager (asm) discussed cataract incision geometry with doctor.No further information was provided.
Additional Manufacturer Narrative
Corrected data: based on further review of the complaint file, it was noted that the device manufacturer date information was not accurate on the initial medwatch report.The following section have been updated accordingly.Section h4: device manufacturer date: may 22, 2022.

• 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: 21139171
• Report Number: 3012236936-2025-000011
• Device Sequence Number: 20705744
• Product Code: OOE
• UDI-Device Identifier: 05050474617186
• UDI-Public: (01)05050474617186
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 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): 02/13/2025

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: 12/17/2024
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2022
• 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: Prefer Not To Disclose