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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	07/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, doctor (b)(6) reported to cas that she had cut herself on a small tab above the robocone ring arm mount.
Additional Manufacturer Narrative
It was observed that the robocone x axis shim wasn't bent back allowing it to stick up past the force sensor cover.Fse bent the shim per procedure, verified docking and force.Completed system verification, system performs to spec cas checked with the doctor regarding the cut she received.She stated she was doing good with no issues.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: 50015480
• Report Number: 3009026057-2026-00036
• Device Sequence Number: 10514618
• Product Code: OOE
• UDI-Device Identifier: 00867744000150
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 07/21/2026

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: 70-00050-001
• 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: 07/07/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2025
• 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