MAUDE Adverse Event Report: LENSAR, Inc. ALLY Adaptive Cataract Treatment System

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Corneal Perforation (1792)
Date of Event	08/25/2026
Type of Reportable Event	Other
Event or Problem Description
On 09/01/2026, doctor (b)(6) reported to cas that on (b)(6) 2026, they experienced a perforated ak during procedure id #(b)(6).Site is seeking review of the procedure.
Additional Manufacturer Narrative
Review of procedure id #(b)(6) video and imaging shows patient eye movement through-out the procedure.The second arcuate incision at 228 shows a possible posterior perforation with bubbles on the posterior surface of the cornea.It is recommended lowering the arcuate depth to 80% from 85% to reduce this risk if the surgeon is agreeable.Also confirming the patient is locked to the pid arm and not moving is recommended.System functioned as designed.No further clinical follow - up required.

• Brand Name: ALLY Adaptive Cataract Treatment System
• Common Device Name: ALLY Adaptive Cataract Treatment System
• 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 ; +1(888)575-6412
• MDR Report Key: 50857285
• Report Number: 3009026057-2026-00040
• Device Sequence Number: 9508703
• Product Code: OOE
• UDI-Device Identifier: 00867744000150
• UDI-Public: (01)00867744000150(11)240726
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K220529
• 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
• Report Date (Section B): 09/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 70-00050-001
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2024
• 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