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

Model Number	N/A
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	02/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of procedure # (b)(6) video and imaging shows significant patient decentration in the pid ring and movement during the procedure.This would most likely lend itself to incomplete or tagged areas on the capsulotomy, requiring careful removal of the capsular button during the cataract removal portion of the procedure.The capsular tear may have occurred during the cataract removal portion of the procedure.A review of locking / centration technique with the pid ring to and pid arm and button removal best practices after an incomplete capsulotomy has happened due to patient movement.System functioned as designed.No further clinical follow-up required.
Event or Problem Description
On (b)(6) 2026, doctor ((b)(6)) reported to (b)(6) that on (b)(6) 2026 during procedure id # (b)(6), they experienced an incomplete capsulotomy and radial tear.
Additional Manufacturer Narrative
Review of procedure (b)(6) video and imaging shows significant pid decentration in the pid ring and patient movement during the procedure.This was viewable to the surgeon prior to the surgery.This would cause incomplete or tagged areas on the capsulotomy, requiring careful removal of the capsular button during the cataract removal portion of the procedure.The capsular tear likely occurred during the cataract removal portion of the procedure as there was ~ 3 clock hours of incomplete capsulotomy.System functioned as designed.Patient received a sulcus iol due to capsular bag instability.Po retina visit with doctor shared that the patient was sent to retina for a vitrectomy within a few days of the posterior capsule tear, and after the retinal surgery the patient had ischemic optic neuropathy.Patient is 20/30 now but with some loss of contrast.No further clinical follow up required.
Event or Problem Description
On 02/06/2026, doctor (b)(6) reported to cas that on (b)(6) 2026 during procedure id (b)(6), they experienced an incomplete capsulotomy and radial tear.

• 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: 24507280
• Report Number: 3009026057-2026-00007
• Device Sequence Number: 9943596
• Product Code: OOE
• UDI-Device Identifier: 00867744000150
• UDI-Public: (01)00867744000150(11)240220
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K220259
• 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,Followup
• Report Date (Section B): 03/03/2026

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): Initial
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2024
• 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