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

Model Number	0030-4864
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Abrasion (1789); Dry Eye(s) (1814); Corneal Clouding/Hazing (1878); Blurred Vision (2137); Visual Impairment (2138); Eye Pain (4467); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section 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 returned for evaluation; 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.
Event or Problem Description
Patient had lasik procedure on (b)(6) 2025 on both eyes and a bandage contact lens was placed.At one day post-op patient reported that his vision is still slightly hazy but improved from surgery day.He has been compliant with pred-moxi in both eyes.Patient is healing well to both eyes.He has some epithelial irregularity in both eyes.At one week post patient reports blurred vision in the left eye at a distance and at near.He reports dryness in both eyes.He reports compliance pred-moxi 3 times daily in both eyes.At one month post op patient presents with epithelial ingrowth in the left eye and blurry vision.He continues to instill pred-moxi once daily in both eyes.On (b)(6) 2025, patient presents for flap lift with epithelial ingrowth removal, left eye.At one day post op flap debridement in left eye patients states vision is doing well and also reported pain but had diminished.On (b)(6) 2025, patient presented for follow up after flap debridement, left eye.He states the left eye has not improved.On (b)(6) 2025, patient presents for lasik enhancement evaluation, left eye.He reports the left eye is blurred at all ranges.No additional information has been provided.Left eye best corrected visual acuity (bcva): on (b)(6) 2025: 20/20, on (b)(6) 2025: 20/30.

• 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: 23865637
• Report Number: 3012236936-2025-000341
• Device Sequence Number: 5318658
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/22/2025

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: 0030-4864
• Device Catalogue Number: 0030-4864
• 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: 11/24/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2008
• 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: Required Intervention
• Patient Age: 30 YR
• Patient Sex: Male