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	09/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Measure: this issue only impacted this specific device.Analyze: senior cas (b)(4) reviewed the open call for (b)(4).(b)(4) - centration is good with minimal suction.Minor to major movement is noted throughout treatment.Root cause: patient movement contributed to possible double cuts to capsulotomy resulting in a weaken capsule area.Laser functioned as designed.Improve/innovate/control: stabilization of the patient's head to reduce movement.
Event or Problem Description
(b)(4).Anterior capsular radial tear - issue: on (b)(6) 2022 (b)(6) on site at (b)(4) for surgeon training with dr.(b)(6).A tagdefender was noted prior to treatment on case #182.Tag defender was acknowledged, and (b)(6) explained the options.Dr.(b)(6) proceeded to treat.The capsulotomy was completed about 90 % around except 10 degrees inferior.At the microscope it was noted by the surgeon the cornea had some tear film irregularity inferiorly at the site of the incomplete capsulotomy.Dr (b)(6) proceeded to finish the capsulotomy manually and had a radial runout to the periphery.His view was limited by the tear film and surfaceirregularity.During the ia the tear extended to posterior.Dr (b)(6) completed a brief anterior vit and implanted a sulcus lens successfully.

• 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: 15695501
• Report Number: 3009026057-2022-00032
• Device Sequence Number: 6763474
• Product Code: OOE
• UDI-Device Identifier: 10867744000119
• UDI-Public: (01)10867744000119(11)220223
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 10/28/2022

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: 70-00013-001
• 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: 09/28/2022
• Initial Report FDA Received Date: 10/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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