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 12/12/2023

Event Type  Injury  

Manufacturer Narrative

Procedure id (b)(6) was reviewed.It does appear they docked a few times causing a film on the bottom of the surgical window.The capsular button appeared to have been removed easily with no adhesions.Surgical footage indicates the tear happened during hydrodissection.Findings were communicated to the doctor.

Event Description

P1008 - posterior radial tear -issue: on (b)(6) 2023, (lls2223) reported to cas that dr.Experienced a posterior tear on his last case of the day on (b)(6) 2023 on procedure #1966.Per dr., this has been an ongoing problem despite various laser setting changes and support visits.

• 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: 18503950
• MDR Text Key: 332879022
• Report Number: 3009026057-2023-60130
• 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: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• 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: 70-00005-001
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2012
• 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