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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	01/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Measure: this issue only impacted this specific device.Analyze: senior (b)(6) reviewed the open call for (b)(4): case (b)(4) - centration was good with poor suction applanation to the eye.Eye movement is noted throughout treatment.A double cut of the capsulorhexis in the nasal area is observed at frame #3 to #6.Patient movement during laser treatment can cause poor stabilization of the cut, resulting in capsulorhexis tears.Adequate suction applanation to the eye with proper docking and locking of the pid arm to the eye cup will reduce eye movement.Improve/innovate/control: (b)(6) will discuss findings with surgeon and staff.
Event or Problem Description
(b)(6) reported to customer service on 01/27/2022 that dr.(b)(6) from (b)(4) had a broken capsular nasal today.Action: log files were sent in for review.(b)(6) would like to know the findings.

• 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
• Manufacturer Contact: keith peck ; 2800 discovery drive ste. 100; orlando, FL 32826 ; 8885756412
• MDR Report Key: 13584835
• Report Number: 3009026057-2022-00010
• Device Sequence Number: 17596746
• Product Code: OOE
• UDI-Device Identifier: 10867744000119
• UDI-Public: (01)10867744000119(11)200303
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/22/2022

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: 70-00005-001
• 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: 01/27/2022
• Initial Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2020
• 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