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

Model Number	UNK-EXCIMER
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
The following article was received based on a literature review: a retrospective study was done to analyze the visual outcomes of kamra (acufocus inc) inlay insertion in a cohort of patients reporting success of procedure, complications, patient satisfaction, and refractive outcomes.A total of 35 patients underwent kamra inlay insertion.There were 9 patients with a sole kamra inlay insertion, 15 had combined laser vision correction (lvc) and kamra inlay insertion on the same day, and 11 had sequential lvc and kamra inlay insertion.The intralase femtosecond laser (advanced medical optics inc.), was used to create a laser-assisted in situ keratomileusis (lasik) flap while lvc ablation was performed with the isx star s4 ir laser (johnson & johnson vision) on patients who underwent simultaneous consecutive lvc and kamra inlay insertion.Postoperative complications reported include striae (n=1 patient), epithelial ingrowth (n=1 patient), and late-onset ectasia (n=2 patients).Patients who underwent enhancement include 8 that underwent lasik, 1 photorefractive keratectomy, and 2 cross-linking via the dresden protocol.This report is against the star laser.A separate report will be filed against the intralase laser.
Additional Manufacturer Narrative
Section a2: age: the average age of patients under-going the procedure was 53 years section a3: gender: 18 were female and 17 male.Section b3: date of event: exact dates not provided.Article acceptance date is november 7, 2022.The study was conducted for surgeries performed between (b)(6) 2014.Device evaluation product testing could not be performed because the product was not returned.Therefore, a failure analysis of the complaint device cannot be completed, and the reported event cannot be confirmed.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.Citation: darian-smith, e., gouvea, l., gendler, s., alshaker, s., din, n., weill, y., skouras, n., rabinovitch, t., singal, n., chan, c.C., & rootman, d.S.(2024).Kamra presbyopic inlay refractive outcomes: a canadian perspective.Canadian journal of ophthalmology, 59(1),.7¿11.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 ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 21885734
• Report Number: 3012236936-2025-000113
• Device Sequence Number: 8097702
• Product Code: LZS
• UDI-Device Identifier: 05050474573413
• UDI-Public: (01)05050474573413
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2025

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: UNK-EXCIMER
• 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: 03/27/2025
• Initial Report FDA Received Date: 04/22/2025
• 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 Sex: Unknown