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

Model Number	EXCIMER
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Abrasion (1789); Dry Eye(s) (1814); Visual Disturbances (2140); Eye Pain (4467); Unspecified Eye / Vision Problem (4471); Eye Irritation (4803)
Date of Event	11/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section d4: model#, catalogue#, expiration date, udi#, serial#: unknown/not provided.Section d6a: implant date: not applicable to suspect device.Section d6b: explant date: not applicable to suspect device.Section e1: first/given name: unknown, as information was requested but not provided.Section e1: last name: unknown, as information was requested but not provided.Section e1: email address: unknown, as information was requested but not provided.Section e1: establishment name, address, city and post office or zip code: unknown, as information was requested but not provided.Section e1: telephone number: unknown as information was not provided.Section h4: device manufacture date: unknown as product serial number was not provided.Section h3: the device was not returned for evaluation and no information is available on it.Therefore, a failure analysis of the complaint device could not be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a medical device report (mdr) was submitted regarding a patient who underwent lasek eye surgery in the uk in 2022, using the visx star s4 ir excimer laser system.Since the procedure, the patient has experienced ongoing dry eye, corneal neuralgia, and symptoms including constant pain, burning, itching, corneal abrasion, fatigue, light sensitivity, and mental health challenges.The patient reported using various treatments, including eye drops, ointments, heat masks, lid hygiene, and supplements, over the past two and a half years without resolution.No further information was provided.

• 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 ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 22913649
• Report Number: 3012236936-2025-000211
• Device Sequence Number: 18358601
• Product Code: LZS
• UDI-Device Identifier: 05050474573413
• UDI-Public: (01)05050474573413
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P910062
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/28/2025

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: EXCIMER
• 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: 08/04/2025
• Initial Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 73 YR
• Patient Sex: Female
• Patient Race: Asian