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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Capsular Bag Tear (2639)

Event Date 03/30/2023

Event Type  Injury  

Manufacturer Narrative

Measure: this issue only impacts this specific device.Analyze: (b)(6) reviewed the open call for lls5111.Case #(b)(4) - fair centration with adequate suction is noted.The capsulotomy firing starts at frame 3 and completes at frame 10.Fragmentation beginning right after on frame 11 and completing at frame 27.Patient movement is not noted throughout the entirety of the procedure.Laser functioned as designed root cause: surgical technique during to cortex removal.

Event Description

Procedure id (b)(4).During cortex removal after (b)(4) dr.Noted a fragmentation imprint on the cortex.When she pulled the first piece of cortex with ia the vitreous came into the anterior chamber and there appeared to be no posterior capsule.An anterior vitrectomy was performed and a 3 piece iol was placed in the sulcus.

• Brand Name: LENSAR LASER SYSTEM-FS 3D
• Type of Device: 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: 16829668
• MDR Text Key: 314162875
• Report Number: 3009026057-2023-54614
• Device Sequence Number: 1
• Product Code: OOE
• UDI-Device Identifier: 00867744000112
• UDI-Public: (01)00867744000112(11)200303
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other