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	12/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, while cas was on site for surgery support, doctor ((b)(6)) reported that they noted a full thickness ak during procedure id # (b)(6).This procedure was performed on (b)(6) 2025.
Additional Manufacturer Narrative
Review of procedure id# (b)(6) video and imaging shows patient movement during the first part of procedure and right after ak was made changing eye positioning from the point of scanning.1 arcuate incision of 70 degree @ 35 was programmed with a 600 micron fixed depth and residual 150 micron bed depth with energy at 3.0uj.Bubbles appear to be in the anterior chamber after the arcuate was made indicating potential posterior penetration of the cornea in that region.Recommend review of locking patient and pausing treatment during movement and adjusting ak depth to 80% and energy to 2.8uj.System functioned as desinged.No further clinical follow up is 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 ; 8885756412
• MDR Report Key: 25067271
• Report Number: 3009026057-2026-00020
• Device Sequence Number: 10748120
• Product Code: OOE
• UDI-Device Identifier: 00867744000150
• UDI-Public: (01)00867744000150(11)240904
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 04/28/2026

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: 04/16/2026
• Initial Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2024
• 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