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

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problems Corneal Perforation (1792); Capsular Bag Tear (2639)

Event Date 12/15/2023

Event Type  Injury  

Manufacturer Narrative

Procedure id (b)(4) was reviewed.The suction ring is decentered, and it is noted during the ak creation, a small bubble did migrate into the anterior chamber.This indicates a potential micro perforation in the cornea.A very decentered suction ring can lead to this event.No further follow up.

Event Description

P1038 - n/a - issue: on 12/15/2023, (b)(6) reported to service that during procedure id #(b)(4), dr.Experienced a moderate size gas bubble within the eye after the first ak incision.Dr.Is requesting review of the procedure.

Event Description

(b)(4) - n/a - issue: on (b)(6) 2023, ((b)(6)) reported to service that during procedure id # (b)(6), dr.Experienced a moderate size gas bubble within the eye after the first ak incision.Dr.Is requesting review of the procedure.

Manufacturer Narrative

Procedure id (b)(6) was reviewed.The suction ring is decentered, and it is noted during the ak creation, a small bubble did migrate into the anterior chamber.This indicates a potential micro perforation in the cornea.A very decentered suction ring can lead to this event.No further follow up.

• 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: 18504414
• MDR Text Key: 332792932
• Report Number: 3009026057-2024-00001
• 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,Followup

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: 12/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2014
• 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