MAUDE Adverse Event Report: STAR S4 IR; EXCIMER LASER SYSTEM

Model Number	0030-4864
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Visual Impairment (2138); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight & ethnicity: unknown/ not provided.(b)(4).The system was evaluated by a field service engineer (fse).Fse aligned calibration arm using alignment tool.Adjusted aspirator tube to proper height and centering.Checked microscope focus, reticle, fixation alignment and axis calibration and all were good.Confirmed iris was stable.The system met johnson & johnson specs upon departure.A review of the records related to this equipment that included labeling, manual, and risk documentation reviews for this equipment was performed.Equipment labeling provides possible complications that can be caused by the surgical/treatment procedure being performed.The trend review shows that there is not a recognizable adverse trend.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.There was no product deficiency identified.All pertinent information available to johnson & johnson surgical vision has been submitted.
Event or Problem Description
It was reported that patient presented with central island on the right which was discovered after weekly follow up.This was a moderate myopia with cyl.Pre-op best corrected visual acuity (bcva) 20/15, current bcva 20/30 (as of (b)(6) 2021).

• Brand Name: STAR S4 IR
• Common Device Name: EXCIMER LASER SYSTEM
• MDR Report Key: 12389381
• Report Number: 2020664-2021-07256
• Device Sequence Number: 4633750
• Product Code: LZS
• UDI-Device Identifier: 05050474573413
• UDI-Public: (01)05050474573413
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/30/2021

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?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 08/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2008
• 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 Age: 24 YR