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 08/24/2023

Event Type  Injury  

Manufacturer Narrative

Measure: this issue only impacted this specific device.Analyze: (b)(6) reviewed the open call for (b)(6): case#: (b)(4) od, adequate centration with suction applanation to the eye.Minimal eye movement is noted throughout treatment.Capsulotomy firing began in frame 3 with good break through.Capsulotomy completed.Case#: (b)(4) os, adequate centration with suction applanation to the eye.Minimal eye movement is noted throughout treatment.Capsulotomy firing began in frame 3 with good break through.Anterior cortical/cortex noted at 6 oclock.Root cause: #: (b)(4) patient movement and poor surgical technique may have contributed to anterior tear.#: (b)(4) patient movement and anterior cortical/cortex may have contributed to anterior tear.No further follow up required.

Event Description

P1008 - anterior radial tears issue: on (b)(6) 2023, while (b)(6) was on site (b)(6), dr.Reported that he has had 2 recent anterior tears, and both seemed to be in the 6 o'clock position.

• 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: 17802879
• MDR Text Key: 324106847
• Report Number: 3009026057-2023-57618
• Device Sequence Number: 1
• Product Code: OOE
• 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: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• 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: 70-00005-001
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2021
• 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