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	06/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of procedure id #'s (b)(6) show some patient movement but no definitive sign was noticed in terms of a full thickness arcuate incisions on either of the procedures.Patient movement can lead to perforation if the patient is pushing upwards during that part of the procedure.Monitoring patient movement is part of the surgeon's responsibility when treating.They can always stop the procedure at any time by taking their foot off the pedal and resuming treatment by depressing the pedal again when the patient is no longer moving.System functioned as designed.No further clinical follow up required.
Event or Problem Description
On 06/02/2026, doctor (b)(6) reported to cas that they experienced full thickness aks during procedure ids # (b)(6).

• 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: 25487985
• Report Number: 3009026057-2026-00029
• Device Sequence Number: 15935289
• Product Code: OOE
• UDI-Device Identifier: 00867744000150
• UDI-Public: (01)00867744000150(11)220711
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/12/2026

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: 06/02/2026
• Initial Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2022
• 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