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

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	11/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On 11/29/2024, (b)(6) surgeon reported to lensar customer service that on (b)(6) 2024, case: (b)(4), he experienced a posterior rupture.
Additional Manufacturer Narrative
Case #740 - patient movement observed during the laser procedure is the likely cause of the reported incomplete of the capsulotomy and therefore, a posterior rupture.No further clinical follow-up required as findings were relayed to the doctor.
Event or Problem Description
On 11/29/2024, ((b)(6)) surgeon reported to lensar customer service that on (b)(6) 2024, case 740, he experienced a posterior rupture.

• Brand Name: LENSAR LASER SYSTEM-FS 3D
• Common Device Name: LENSAR LASER SYSTEM-FS 3D
• Manufacturer (Section D): LENSAR, INC.; 2800 discovery drive, ste. 100; orlando 32826
• Manufacturer (Section G): LENSAR,INC.; 2800 discovery drive, ste. 100; orlando 32826
• Manufacturer Contact: keith peck ; 2800 discovery drive, ste. 100; orlando, FL 32826 ; 8885756412
• MDR Report Key: 20966072
• Report Number: 3009026057-2024-00062
• Device Sequence Number: 3955068
• Product Code: OOE
• UDI-Device Identifier: 00867744000112
• UDI-Public: (01)00867744000112(11)210927
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K182795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/29/2024
• Supplement Date Received by Manufacturer: 11/29/2024
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown