MAUDE Adverse Event Report: AMO Manufacturing USA, LLC FS LASER SYSTEM; Powered Laser Surgical Instrument

Model Number	20005D
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that the patient interface (pi) had suction loss during the raster pattern, and the stromal bed showed a divet after the lift.There was no patient injury or surgical intervention reported.No further information was provided.Note: this report is against the fs laser.A separate report will be filed against the patient interface.
Additional Manufacturer Narrative
Section a2 a3, a4 and a5: unknown/ not provided.Section d6a: if implanted, give date: not applicable, as the device is not implantable.Section d6b: if explanted, give date: not applicable, as the device is not implantable.Section h3: the device was not evaluated; therefore, a failure analysis of the complaint device cannot be completed.A review of records including device history record 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 & 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 ; 510 cottonwood drive; milpitas, CA 95035 ; +1(714)247-8552
• MDR Report Key: 50884132
• Report Number: 3012236936-2026-000280
• Device Sequence Number: 10755069
• Product Code: GEX
• UDI-Device Identifier: 05050474573451
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K063682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: 20005D
• Device Catalogue Number: 20005D
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Patient Interface.
• Patient Sex: Unknown