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

Model Number	N/A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Corneal Perforation (1792)
Date of Event	07/14/2026
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 a perforated ak adjacent to the paracentesis incision following procedure id #(b)(6).
Additional Manufacturer Narrative
Review procedure id (b)(6) imaging shows the ak closest to the paracentesis showed bubbles in the anterior chamber creating a slight posterior cornea perforation.Arcuate energy was noted at 3.2uj and incision depth at 85% which is outside the recommended parameters and can lead to perforations on thinner corneas.Recommend local cas changing energy to 2.8uj and 80% depth.System functioned as designed.Patient is recovering well.No 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: 50015867
• Report Number: 3009026057-2026-00037
• Device Sequence Number: 9534934
• Product Code: OOE
• UDI-Device Identifier: 00867744000150
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 07/22/2026

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: 07/15/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2026
• 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