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

Model Number	EL2022
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon complained about an issue with the right eye, where the side cut was not complete and he had to lift it with the help of a surgical instrument.Once the flap was lifted, the excimer laser procedure was completed.The patient is doing well and the results are good.The left eye of the same patient was completed successfully.The patient report from elita indicated that there was vacuum loss, and no error message or warning about this issue was provided.No further information was provided.A separate report is being submitted for the patient interface(pi) involved.This report is for the elita laser.
Additional Manufacturer Narrative
Section a2, a4 and a5: per regulation (b)(4) (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 elita was not evaluated by a filed service engineer.Therefore, a failure analysis of the complaint device could not be completed.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• 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: 20291887
• Report Number: 3012236936-2024-000250
• Device Sequence Number: 7995960
• Product Code: GEX
• UDI-Device Identifier: 05050474738553
• UDI-Public: (01)05050474738553
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): 09/24/2024

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: EL2022
• 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: 09/03/2024
• Initial Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2023
• 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: Female