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

Model Number	0155-1001
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the laser stopped mid patient treatment with the laser error 33-01-01.Through follow-up we learned that when the machine stopped during the treatment at the first time, the surgeon undocked the patient and tried to repeat the treatment on the same session, but the laser stopped again and the patient was stuck, so they had to lift the floating optic head manually to release the patient.The surgeon hasn`t tried to lift the flap and waiting some time before going for a photorefractive keratectomy (prk) or a femto lasik again.No further information was provided.
Additional Manufacturer Narrative
Section a2, a4 and a5: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section d6a - implant date: not applicable.Elita is not an implantable device.Section d6b - explant date: not applicable.Elita is not an implantable device; therefore, not explanted.Section e1 - telephone number: (b)(6).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 and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section h3 - device evaluated by manufacturer? yes device evaluation: product evaluation was performed for this incident via remote support by the engineer.The engineer logged in and extracted the amplitude logs and performed system tests.An a issue was observed and the amplitude laser head was replaced.No further issues were found and the system and its components met all specifications afterwards.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: ELITA
• 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: 23598961
• Report Number: 3012236936-2025-000300
• Device Sequence Number: 18487064
• Product Code: OOE
• UDI-Device Identifier: 05050474738553
• UDI-Public: (01)05050474738553
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K063682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2026

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: 0155-1001
• Device Catalogue Number: 0155-1001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2024
• 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
• Patient Sex: Unknown