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 Codes	Flashers (1864); Visual Impairment (2138); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Event or Problem Description
Literature title: comparison of objective visual quality between smile and fs-lasik in moderate-to-high myopia.A prospective study was done to compare the changes in the corneal wavefront aberrations and the objective visual quality resulting from two types of eye surgery¿small incision lenticule extraction (smile) and femtosecond laser-assisted in situ keratomileusis (fs-lasik)¿in patients with moderate-to-high myopia.A total of 186 eyes of 96 patients with moderate-to-high myopia underwent refractive surgeries, including smile (n=98 eyes of 51 patients) and fs-lasik (n=88 eyes of 45 patients).In the fs-lasik, the cornea flap was created using the intralase ifs 150 femtosecond laser (abbott medical optics, amo) and the excimer laser cutting was performed with an excimer laser machine visx star s4 excimer laser system (advanced medical optics inc.).Corneal higher-order aberration parameters for the fs-lasik group were reported as follows which were assessed by the authors as significant from preoperative values: 1.Total higher-order aberration (thoa).Pre-op: 0.41 ± 0.09 post-op day 1: 0.81 ± 0.34 2.Piston pre-op: 1.39 ± 0.61 post-op day 1: 0.58 ± 1.41 3.Vertical trefoil pre-op: -0.01 ± 0.11 post-op day 1: 0.04 ± 0.13 4.Vertical coma pre-op: -0.11 ± 0.15 post-op day 1: -0.28 ± 0.40 5.Horizontal coma pre-op: 0.03 ± 0.16 post-op day 1: -0.04 ± 0.3 6.Spherical aberration pre-op: 0.28 ± 0.08 post-op day 1: 0.47 ± 0.23.There are no indications in the article of any interventions provided.This report is for the excimer laser.Another report is submitted for intralase femtosecond laser.
Additional Manufacturer Narrative
Section d6a: if implanted, give date: not applicable as this is not an implantable device.Section d6b: if explanted, give date: not applicable as this is not an implantable device.Section e1: address line 1 - (b)(6).Section e1: address line 2 - (b)(6).Section h3: the system was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record cannot be performed as the device serial number is unknown.Section h4: device manufacture date: unknown as serial number was not provided.Citation: zou, h., wei, x., li, l., wei, d., mao, h., huang, y., lu, p., li, z., zhong, d., & chen, q.(2024).Comparison of objective visual quality between smile and fs-lasik in moderate-to-high myopia.Frontiers in medicine, 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: 21885664
• Report Number: 3012236936-2025-000111
• Device Sequence Number: 3552985
• Product Code: LZS
• UDI-Device Identifier: 05050474573413
• UDI-Public: (01)05050474573413
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Health Professional,User Facility
• 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
• Was Device Available for Evaluation?: No
• 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
• Patient Sex: Unknown