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	09/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was an issue with the right eye; the side cut was incomplete.The surgeon did not attempt to lift the flap and decided to redo it at a later stage.The left eye was successfully treated.The surgeon reviewed a picture from the patient report, which clearly showed a vacuum loss.The surgeon stated that there was no error message or warning about this.Daily activities were not significantly affected.The doctor believes the issue was due to patient movement.No further information was provided.A separate report is being submitted for the patient interface.This report pertains to elita.
Additional Manufacturer Narrative
Section 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 - other (81): the elita was not evaluated by a filed service engineer.Therefore, a failure analysis of the complaint device could not 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 and possible product return and evaluation, 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.

• 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: 20371981
• Report Number: 3012236936-2024-000250
• Device Sequence Number: 6877791
• 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): 10/04/2024

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: 09/10/2024
• Initial Report FDA Received Date: 10/04/2024
• 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 Age: 21 YR
• Patient Sex: Female