MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC LIQUID OPTICS INTERFACE; OPHTHALMIC FEMTOSECOND LASER

Model Number	0180-1201
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3, a4 and a5: unknown/ not provided.Section d6a: if implanted, give date: not applicable, as the liquid optics interface is not an implantable device.Section d6b: if explanted, give date: not applicable, as the liquid optics interface 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.
Event or Problem Description
The customer reported recurring loss of suction despite multiple attempts at redocking, caused by a small eye fissure and low patient cooperation.They were able to reach the treatment stage but lost suction during capsulotomy.The procedure was stopped because suction could not be maintained.No patient injuries or additional surgical interventions were reported.
Additional Manufacturer Narrative
Device evaluation: the product was returned to the manufacturing site for evaluation.1 of the reported 1 opened loi was received within original packaging confirming the reported lot number.A visual inspection of the returned product did not reveal any obvious defects or damage.Functional testing was performed, and the results were found not within specifications.The reported event is confirmed.The complaint unit was inspected and tested by the complaint lab and results provided to the external manufacturer.The external manufacturer's evaluation included visual inspection of the actual device, review of production records and historical data analysis.Testing of the actual device was not performed by external manufacturer due to fluid found in device.The fluid is believed to come from use in surgery and not a fault of manufacturing.The manufacturer investigation was unable to confirm the failure and no root cause was identified.It is possible that through handling and/or use that a change to the assembly occurred that had an effect on the flowrate.Adequate controls are in place to ensure product is manufactured and tested to specification requirements.Manufacturing record review: per the external manufacturer's (flex) investigation, the affected device and associated raw materials in question were manufactured in accordance with applicable manufacturing instructions current at the time and were shown to have met applicable inspection criteria and final assembly test requirements.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

• Brand Name: LIQUID OPTICS INTERFACE
• 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 ; 7142478552
• MDR Report Key: 23017862
• Report Number: 3012236936-2025-000241
• Device Sequence Number: 9665360
• Product Code: OOE
• UDI-Device Identifier: 05050474609778
• UDI-Public: (01)05050474609778(17)270223(10)60626517
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170322
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2026

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: 0180-1201
• Device Catalogue Number: 0180-1201
• Device Lot Number: 60626517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CATALYS SYSTEM SERIAL NUMBER (B)(6)
• Patient Sex: Unknown