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	Blurred Vision (2137); Visual Impairment (2138); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that customer complained about decentered ablation after femto-lasik.As per additional information received, there was no any patient injury, however, vision of the patient was not good.Patient needed enhancement as the vision (ucdva) was 20/50, cdva : 6/6+2.Patient's left eye vision was blurred and it affects patient's daily work like driving.Patient complained that the vision was not good for her left eye and still under monitor by the doctor.No further information was provided.
Additional Manufacturer Narrative
Section b3: date of event: unknown/ not provided.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: reporter: telephone number: (b)(6).Section h3: the device was not returned for evaluation.Therefore, a failure analysis of the complaint device cannot 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, if there is any further relevant information a supplemental medwatch will be filed.Section h6 - 4581: decentered ablation.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: 19666918
• Report Number: 3012236936-2024-000177
• Device Sequence Number: 12491131
• Product Code: LZS
• UDI-Device Identifier: 05050474573413
• UDI-Public: (01)05050474573413
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/03/2024

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
• 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: 06/12/2024
• Initial Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2006
• 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: 22 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian