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 01/29/2024

Event Type  Injury  

Manufacturer Narrative

Patient movement is noted throughout treatment.Toric marker at 190-degrees shows signs of double cuts due to movement.This is area is also inline with surgeon's main incision placement.Weaken treatment to the capsulotomy due to patient movement can contribute to a capsule rupture.

Event Description

(b)(4) - n/a issue: (b)(6) reported to customer service on (b)(6) 2024 that (b)(6) (lls2221) reported that he had a capsule rupture today at the toric mark position on procedure 501.

• 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: 18806766
• MDR Text Key: 336550204
• Report Number: 3009026057-2024-00008
• Device Sequence Number: 1
• Product Code: OOE
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• 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: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2012
• 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