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 06/12/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, customer reported that the doctor had a case on (b)(6) 2018 that the superior arcuate perforated.Noticed in or that cornea had some leaking after titrating.Doctor had to suture the area.Patient expected to recover without issue.

• 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
• Manufacturer Contact: keith peck ; 2800 discovery drive ste. 100; orlando, FL 32826 ; 8885756412
• MDR Report Key: 14843446
• MDR Text Key: 294867199
• Report Number: 3009026057-2018-00004
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120214
• 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: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: N/A
• Device Catalogue Number: 70-00005-001
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2014
• 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