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)
Date of Event	01/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2 a3, a4 and a5: as part of the study information for the subject can't be provided.Section h3: the device was not evaluated 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.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
As part of a study, patient had surgery for monovision treatment.Patient consistently complained of blurry vision in the left eye (os), difficulty focusing, and decreased vision, with the complaints worsening over time.After experiencing these symptoms for over six months, the patient preferred surgical intervention.The surgeon chose to proceed with the surgery using the wavelight laser, leading to the patient's exit from the study.No additional information was provided.This report is for the star laser.A separate report will be filed against the idesign.
Additional Manufacturer Narrative
Correction: in the initial report, the manufacturer date provided was inadvertently reported as 03/26/2007, however the correct date is 04/26/2007.Additional information: manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.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: 19923669
• Report Number: 3012236936-2024-000219
• Device Sequence Number: 7244841
• Product Code: LZS
• UDI-Device Identifier: 05050474573413
• UDI-Public: (01)05050474573413
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• 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: Study,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2024

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2007
• 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
• Concomitant Medical Products and Therapy/Usage Dates: IDESIGN G300-3057
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose