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	Visual Impairment (2138); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2, a3, a4, a5 and a6: unknown, as information was requested but not provided.Section d6a - implant date: does not apply - lens was not implanted.Section d6b - explant date: does not apply - lens was not implanted and therefore not explanted.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 - telephone number: (b)(6).Section h3 - the device was not returned for evaluation.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.Section h6 -health effect - clinical code: 4581: hs-eye anatomy issue.An attempt has been made to obtain missing information.However, to date, no response has been received.Additional information: indications and important safety infomation for the star s4 ir® excimer laser system and the idesign¿ systemstar s4 ir excimer laser contraindications read as follows: wavefront-guided lasik surgery is contraindicated in patients with collagen vascular, autoimmune or immunodeficiency diseases; in pregnant or nursing women; in patients with corneal abnormalities including signs of keratoconus, abnormal corneal topography, epithelial basement membrane disease (ebmd) and degenerations of the structure of the cornea.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that during the phototherapeutic keratectomy (ptk) procedure for a patient with zonal corneal degeneration in one eye with the excimer laser system, the postoperative cornea shape analysis revealed the presence of a central island.The settings used for this particular case were as follows: epithelium: plano37, s-0.5d, substantial: 6.0 mm, tz0.3, frequency: 10 hz.No further information was provided.
Additional Manufacturer Narrative
Correction: additional information received on the (b)(6) 2024 was inadvertently not included in report 3012236936-2024-0003216.The field service engineer (fse) visited the account site on (b)(6) 2024 to confirm if there was any issue with the device.The fse couldn't find any malfunctions during the evaluation of the system.Preoperative visual acuity: l 0.4 (0.6p x s+2.50 c-2.00 ax100) postoperative visual acuity ((b)(6) data): l 0.08 (0.4 x s+4.25 c-2.25 ax80).Section h3 device evaluated by manufacturer: yes.Additional information: manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected information: the additional information submitted on the 21st march 2025 under report number 3012236936-2024-0003216 included incorrect information under section g3: date received by manufacturer.The information was received on february 5th, 2025 and not on february 19th, 2025th, as inadvertently reported.Also, the new code under h6 was left out.H6: health effect - clinical code: 2138 - visual impairment.All pertinent information available to johnson and 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: 20872818
• Report Number: 3012236936-2024-000321
• Device Sequence Number: 18350686
• Product Code: LZS
• UDI-Device Identifier: 05050474573413
• UDI-Public: (01)05050474573413
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2025

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: 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: 11/11/2024
• Supplement Date Received by Manufacturer: 02/19/2025; 02/05/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 03/21/2025; 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2008
• 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: Other
• Patient Sex: Unknown