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 Corneal Perforation (1792)

Event Date 07/11/2023

Event Type  Injury  

Manufacturer Narrative

Measure: this issue only impacts this specific device.Analyze: cas, (b)(6) reviewed case#: (b)(4).Suction ring placement was poorly centered with significant patient movement throughout the procedure.The capsulotomy begins in frame #3 and breaks through in frame #7 followed by lens fragmentation.Ak #1 begins in frame #26 and ak #2 begins in frame #41.Significant patient movement is noted when both incisions are being completed.Root cause: poor suction ring placement and significant patient movement could cause a full thickness arcuate incision.Laser functioned as designed.No further follow up.

Event Description

On 07/11/2023, (b)(6) reported via text that dr.Had a full thickness ak incision on procedure#: (b)(4).Sutures were used to close wound.

• 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: 17513905
• MDR Text Key: 321040498
• Report Number: 3009026057-2023-56604
• 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: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• 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: 07/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2013
• 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