MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC INTRALASE TECHNOLOGY PI; POWERED LASER SURGICAL INSTRUMENT

Model Number	0155-1825
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
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 e1 - telephone number: (b)(6).At the time of the investigation, product was not available for evaluation, therefore no testing could be performed.The reported event cannot be confirmed.The manufacturing records for the device were reviewed.The product was manufactured and released according to specification.Based on the information obtained, product malfunction or product deficiency could not be confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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 elita.This report pertains to the patient interface.

• Brand Name: INTRALASE TECHNOLOGY PI
• 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: 20373108
• Report Number: 3012236936-2024-000250
• Device Sequence Number: 3889449
• Product Code: GEX
• UDI-Device Identifier: 05050474655690
• UDI-Public: (01)05050474655690(17)251023(10)71992057
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K060372
• 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 Expiration Date: 10/23/2025
• Device Model Number: 0155-1825
• Device Catalogue Number: 0155-1825
• Device Lot Number: 71992057
• 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): Yes
• Date Device Manufactured: 10/23/2023
• 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
• Patient Age: 21 YR
• Patient Sex: Female