MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC STAR S4 IR; EXCIMER LASER SYSTEM

Model Number	0030-4864
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that their bed was moving.Following our field service engineer (fse) visit to perform repairs, the customer stated, "everything is functioning well, no issues.We have completed one treatment after the repair, and there were no problems with the bed moving.The bed movement did not impact patient outcomes.".
Additional Manufacturer Narrative
Section a2, a3, a4, a5, and a6: unknown/ not provided.Section d6a: if implanted, give date: not applicable, as the device is not an implantable device.Section d6b: if explanted, give date: not applicable, as the device is not an implantable device.Section h3: our field service engineer (fse) was onsite for service.Fse replaced the joystick cables from the joystick to the remote printed circuit board (pcb) inside the direct current (dc) box.Fse replaced the emi db9 filter inside the dc box.Fse also replaced the lens (l2) and output coupler optics.System meets manufacturers specifications.A review of records including device history 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.
Additional Manufacturer Narrative
Additional data: product investigation was completed and additional component codes were provided.The following sections have been updated accordingly.Section h6 - component codes: component code 423 - cable, electrical.Component code 866 - lenses.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Section h11.Corrected data: upon reviewing the information received, the uncontrolled chair movement did not occur during the use of the star excimer laser.This case is no longer considered a reportable malfunction.Therefore, this follow-up #2 is being submitted to provide the corrected data.There will no longer be any further reporting under medwatch report number 3012236936-2025-0003313.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: STAR S4 IR
• Common Device Name: EXCIMER LASER SYSTEM
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 510 cottonwood drive; milpitas, CA 95035 ; 7142478552
• MDR Report Key: 23764196
• Report Number: 3012236936-2025-000331
• Device Sequence Number: 16092449
• Product Code: LZS
• UDI-Device Identifier: 05050474573413
• UDI-Public: (01)05050474573413
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P910062
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2026

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: 0030-4864
• Device Catalogue Number: 0030-4864
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: 01/30/2026; 02/17/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 02/11/2026; 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2007
• 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: Unknown