MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC ELITA; POWERED LASER SURGICAL INSTRUMENT

Model Number	0155-1001
Medical Device Problem Codes	Decrease in Suction (1146); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2025
Type of Reportable Event	Malfunction
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.The device is not an implantable device.Section d6b - explant date: not applicable.The device 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.
Event or Problem Description
It was reported that during a procedure, suction loss occurred on the patient's left eye (os) while using the elita system.The surgeon noted that the system did not provide any notification of the suction loss during the laser firing.As a result, the treatment continued until completion, but the surgeon was unable to lift the flap or locate the side cut.Consequently, the treatment for this eye was converted from lasik to photorefractive keratectomy (prk).The customer highlighted the need for the elita system to have the capability to monitor a live image of the eye during treatment and expressed concern regarding the lack of notifications for suction loss.No additional information was received.This report is for elita.A separate report is being submitted for the patient interface.

• Brand Name: ELITA
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• 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: 22020359
• Report Number: 3012236936-2025-000122
• Device Sequence Number: 13114758
• Product Code: GEX
• UDI-Device Identifier: 05050474738553
• UDI-Public: (01)05050474738553
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K063682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2025

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
• 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: 04/18/2025
• Initial Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2023
• 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