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

Model Number	N/A
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	03/30/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of procedure id#2121 shows a manual cylinder and axis entry of 0.30d @ 23 and manual entry of a single 45 degree arcuate @ 23.Procedure id#2287 shows a manual cylinder and axis entry of 0.20d @ 18 and a manual entry of a single 60 degree arcuate @ 18.The surgeon table used for calculating arcuates that is on the system was not used by the site to calculate the arcuates, and the astigmatism values and arcuate length and axis were entered into the system by the site.The system treated both procedures as programmed.Recommend the site verify the pre-op data and surgery plan with the surgeon and compare it to the values entered in the system to determine cause of reported overcorrection.System functioned as designed.The site is planning post operative care for the patients, with either providing lasik or an iol exchange.No further clinical follow-up required.
Event or Problem Description
On (b)(6) 2026, doctor (b)(6) reported to cas that they noted on procedure ids #2121 and #2287 resulted in an overcorrection postoperatively.

• 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: 24979863
• Report Number: 3009026057-2026-00015
• Device Sequence Number: 15877630
• 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): 04/17/2026

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: 03/31/2026
• Initial Report FDA Received Date: 04/24/2026
• 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