MAUDE Adverse Event Report: LENSAR, INC LENSAR LASER SYSTEM-FS 3D

Model Number	N/A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Measure: this issue only impacted this system and there is no impact to any other fielded device at this time.Analyze: a service call was opened to document dr.Barnett's comment to mia jefic.He indicated that they had an issue with the astigmatic outcome on a patient and that he believed it was related to the bed orientation.Multiple attempts were made with the facility to retrieve the patient data for review, but the site refused to send the data.The system was removed and returned to the corporate office in orlando on (b)(6) 2023 at the end of the contract.Patient data was retrieved from the unit and post processed.It was confirmed that a few patients did in fact have the wrong bed orientation programmed into the system configuration.The wrong bed orientation could affect the astigmatic outcome.Root cause: patient bed orientation was configured incorrectly.Improve/innovate/control: it was confirmed that the wrong bed orientation was programmed on some patients.The wrong bed orientation can impact the astigmatic outcome.Dr.Barnett did state that he had two patients that required follow up surgery to rotate their toric lenses so that they were on the correct axis.He stated that both patients are currently seeing 20/20 or better.Further review shows that the site did correct the bed orientation in the system configuration.No further action is required at this time.
Event or Problem Description
On (b)(6) 2023, dr.Notified cas and indicated that they had an issue with the astigmatic outcome on apatient and believe that it was related to the bed orientation.

• Brand Name: LENSAR LASER SYSTEM-FS 3D
• Common Device Name: LENSAR LASER SYSTEM-FS 3D
• Manufacturer (Section D): LENSAR, INC; 2800 discovery drive ste.100; orlando FL 32826
• Manufacturer (Section G): LENSAR, INC; 2800 discovery drive ste. 100; orlando FL 32826
• MDR Report Key: 17611944
• Report Number: 3009026057-2023-55338
• Device Sequence Number: 20519660
• Product Code: OOE
• UDI-Device Identifier: 00867744000112
• UDI-Public: 010086774400011211211108
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K182795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/23/2023

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: N/A
• Device Catalogue Number: 70-00013-001
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2023
• Initial Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2014
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown