MAUDE Adverse Event Report: LENSAR, INC. ALLY ADAPTIVE CATARACT TREATMENT SYSTEM

Model Number	N/A
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Corneal Perforation (1792)
Date of Event	04/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of procedure id# (b)(6) video shows significant patient movement throughout the procedure and during arcuate incisions.Patient doesn't appear to be locked and the eye is decentered significantly.Patient movement and decentration may have led to posterior cornea being compromised during the arcuate portion of the procedure.Recommend discussing proper centration and locking during the procedure.The full thickness is sealed and patient is doing well post op.No further clinical follow up is required.
Event or Problem Description
On (b)(6) 2026, doctor (b)(6) reported to cas that while attempting to insert the intraocular lens on procedure id # (b)(6), he noted that viscoelastic began to come out of the temporal ak causing a full thickness ak.

• 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: 25116263
• Report Number: 3009026057-2026-00019
• Device Sequence Number: 15776139
• Product Code: OOE
• UDI-Device Identifier: 00867744000150
• UDI-Public: (01)00867744000150(11)240517
• 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): 05/05/2026

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: 04/14/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2024
• 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