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

Model Number	20005D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Eye Injury (1845); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer encountered a vertical gas breakthrough (vgb) on the second eye oculus sinister os (left eye) in the final 5 seconds of the femtosecond laser flap procedure.Consequently, the surgeon was unable to fully lift the flap and did not proceed with the excimer treatment on the left eye.A bandage contact lens was applied to the left eye for one day, and the surgeon plans to perform a surface ablation at a later date to complete the excimer treatment.The treatment on the oculus dexter od (right eye) was completed as expected.On 1 day post-op, customer reported that the patient is doing well in both eyes, with the treated right eye achieving 20/15 vision and the left eye maintaining its best corrected visual acuity without any loss of lines.
Additional Manufacturer Narrative
Section a2, a4 and a5: unknown/ not provided.Section d6a: if implanted, give date: not applicable, as the laser system is not an implantable device.Section d6b: if explanted, give date: not applicable, as the laser system is not an implantable device.Section h3: the clinical application specialist was onsite and performed an upgrade.The system was performing to specification.A review of the device history record, complaint trending, and risk documentation for this device 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 & johnson surgical vision, inc has been submitted.
Additional Manufacturer Narrative
Corrected data: upon further review it was determined that section h6 type of investigation in the initial report was inadvertently provided.The correct code is 4114.Therefore, this supplemental report is being submitted to provide the correct data.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: FS LASER SYSTEM
• 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: 21314186
• Report Number: 3012236936-2025-000031
• Device Sequence Number: 12799736
• Product Code: GEX
• UDI-Device Identifier: 05050474573451
• UDI-Public: (01)05050474573451
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 20005D
• Device Catalogue Number: 20005D
• 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: 01/09/2025
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2009
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose