ALLY 70-00050-001Recalls & reported problems
LENSAR, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This LENSAR ALLY ophthalmic femtosecond laser is used in eye surgery. The 77 reports mostly describe capsular bag tears and corneal perforations during the procedure. There are 77 reports, no deaths and 77 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 81
- Deaths reported
- 0
- Injuries reported
- 80
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 00867744000150), received between Aug 24, 2022 and Sep 22, 2026 — classified as 80 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (21 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem29
- Patient Device Interaction Problem21
- Patient-Device Incompatibility16
- Improper or Incorrect Procedure or Method4
- Use of Device Problem4
- Use of Incorrect Control/Treatment Settings4
- Device Handling Problem2
- No Apparent Adverse Event2
Patient problems
- Capsular Bag Tear43
- Corneal Perforation34
- Visual Impairment3
- Corneal Edema1
- Skin Tears1
Recent adverse event reports
The 25 most recent of 81 reports, in the reporter's own words as published by the FDA.
InjurySep 22, 2026No Apparent Adverse Event
Patient problems: Corneal Perforation
MAUDE report 50857293 ↗OtherSep 22, 2026Patient Device Interaction Problem
On 09/01/2026, Doctor (b)(6) reported to CAS that on (b)(6) 2026, they experienced a perforated AK during Procedure ID #(b)(6). Site is seeking review of the procedure.
Patient problems: Corneal Perforation
MAUDE report 50857285 ↗InjuryJul 27, 2026Use of Device Problem
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).
Patient problems: Corneal Perforation
MAUDE report 50015867 ↗InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem
On (b)(6) 2026, Doctor (b)(6) reported to CAS that she had cut herself on a small tab above the Robocone ring arm mount.
Patient problems: Skin Tears
MAUDE report 50015480 ↗InjuryJul 6, 2026Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2026, DOCTOR (B)(6) REPORTED TO CAS THAT THEY EXPERIENCED A FULL THICKNESS ARCUATE INCISION DURING PROCEDURE ID#: (B)(6).
Patient problems: Corneal Perforation
MAUDE report 25716595 ↗InjuryJun 29, 2026Patient-Device Incompatibility
ON 06/08/2026, DOCTOR ((B)(6)) REPORTED TO CAS THAT THEY EXPERIENCED A POSTERIOR RUPTURE DURING THE PHACO PORTION OF PROCEDURE ID # (B)(6).
Patient problems: Capsular Bag Tear
MAUDE report 25650379 ↗InjuryJun 12, 2026Use of Device Problem
ON 06/02/2026, DOCTOR (B)(6) REPORTED TO CAS THAT THEY EXPERIENCED FULL THICKNESS AKS DURING PROCEDURE IDS # (B)(6).
Patient problems: Corneal Perforation
MAUDE report 25487985 ↗InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2026, DOCTOR (B)(6) REPORTED TO CAS THAT THEY EXPERIENCED ANTERIOR CAPSULAR TEARS ON PROCEDURE IDS # (B)(6).
Patient problems: Capsular Bag Tear
MAUDE report 25319713 ↗InjuryMay 28, 2026Patient Device Interaction Problem
ON 05/18/2026, DOCTOR (AL23032-C21U) REPORTED TO CAS THAT THEY EXPERIENCED ANTERIOR CAPSULAR TEARS ON PROCEDURE IDS #2162 AND #2163.
Patient problems: Capsular Bag Tear
MAUDE report 25319278 ↗InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2026, WHILE CAS WAS ON-SITE FOR SURGERY SUPPORT, DOCTOR (B)(6) REPORTED THAT THEY EXPERIENCED A CAPSULAR TEAR AT 12O'CLOCK FOLLOWING PROCEDURE ID # (B)(6).
Patient problems: Capsular Bag Tear
MAUDE report 25319176 ↗InjuryMay 28, 2026Patient Device Interaction Problem
ON (B)(6) 2026, DOCTOR (B)(6) REPORTED TO CAS THAT ON PROCEDURE ID # (B)(6), THEY REPORTED A FULL THICKNESS AK THAT WAS LEAKING DURING SURGERY.
Patient problems: Corneal Perforation
MAUDE report 25317815 ↗InjuryMay 7, 2026Patient-Device Incompatibility
ON (B)(6) 2026, WHILE CAS WAS ON-SITE FOR SURGERY SUPPORT, DOCTOR (B)(6) REPORTED THAT THERE WAS A SMALL ANTERIOR TEAR WHEN REMOVING THE BUTTON DURING PROCEDURE ID # (B)(6). THE SITE AND SURGEON ARE SEEKING REVIEW.
Patient problems: Capsular Bag Tear
MAUDE report 25116340 ↗InjuryMay 7, 2026Device Handling Problem
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.
Patient problems: Corneal Perforation
MAUDE report 25116263 ↗InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2026, DOCTOR (B)(6) REPORTED TO CAS THAT THEY EXPERIENCED A RADIAL TEAR AT THE "JUNCTION OF THE TORIC CAPSULE NUB" DURING PROCEDURE ID # (B)(6).
Patient problems: Capsular Bag Tear
MAUDE report 25116086 ↗InjuryMay 4, 2026Patient Device Interaction Problem
ON (B)(6) 2026, WHILE CAS WAS ON SITE FOR SURGERY SUPPORT, DOCTOR ((B)(6)) REPORTED THAT THEY NOTED A FULL THICKNESS AK DURING PROCEDURE ID # (B)(6). THIS PROCEDURE WAS PERFORMED ON (B)(6) 2025.
Patient problems: Corneal Perforation
MAUDE report 25067271 ↗InjuryMay 4, 2026Patient Device Interaction Problem
ON (B)(6) 2026, DOCTOR (B)(6) REPORTED TO CAS THAT DURING PROCEDURE ID #1507, FULL THICKNESS OCCURRED DURING THE TEMPORAL AK. THEY NOTED THAT A SUTURE WAS PLACED.
Patient problems: Corneal Perforation
MAUDE report 25067253 ↗InjuryApr 24, 2026Use of Incorrect Control/Treatment Settings
ON (B)(6) 2026, DOCTOR (B)(6) REPORTED TO CAS THAT THEY NOTED PROCEDURE IDS #1709 AND #1965 RESULTED IN AN OVERCORRECTION POSTOPERATIVELY.
Patient problems: Visual Impairment
MAUDE report 24979922 ↗InjuryApr 24, 2026Use of Incorrect Control/Treatment Settings
ON (B)(6) 2026, DOCTOR (B)(6) REPORTED TO CAS THAT THEY NOTED ON PROCEDURE IDS #2121 AND #2287 RESULTED IN AN OVERCORRECTION POSTOPERATIVELY.
Patient problems: Visual Impairment
MAUDE report 24979863 ↗InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem
ON 03/22/2026, DOCTOR ((B)(6)) REPORTED TO CAS THAT DURING PROCEDURE ID #(B)(4), HE EXPERIENCED A LEAKING FULL THICKNESS ARCUATE.
Patient problems: Corneal Perforation
MAUDE report 24872183 ↗InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2026, WHILE CAS WAS ON-SITE FOR SURGERY SUPPORT, DOCTOR (B)(6) REPORTED THAT HE NOTED A POSTERIOR CAPSULAR TEAR ON PROCEDURE IDS # (B)(6) THE SITE IS SEEKING REVIEW OF CASES.
Patient problems: Capsular Bag Tear
MAUDE report 24640349 ↗InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2026, WHILE CAS WAS ON-SITE FOR SURGERY SUPPORT, DOCTOR (B)(6)) NOTED THAT PROCEDURE ID #(B)(6) HAD A RADIAL CAPSULAR TEAR.
Patient problems: Capsular Bag Tear
MAUDE report 24557375 ↗InjuryMar 4, 2026Improper or Incorrect Procedure or Method; Patient Device Interaction Problem
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.
Patient problems: Capsular Bag Tear
MAUDE report 24507280 ↗InjuryMar 3, 2026Patient Device Interaction Problem
ON (B)(6) 2026, WHILE CAS WAS ONSITE FOR SURGERY SUPPORT, DOCTOR ((B)(6)) REPORTED THAT FOR PROCEDURE ID # (B)(6), IT WAS NOTED AK #2 WAS FULL THICKNESS AFTER OPENING.
Patient problems: Corneal Perforation
MAUDE report 24496155 ↗InjuryMar 3, 2026Patient Device Interaction Problem
ON (B)(6) 2026, WHILE CAS WAS ONSITE FOR SURGERY SUPPORT, DOCTOR ((B)(6)) REPORTED A CAPSULAR TEAR FOR PROCEDURE ID# (B)(6).
Patient problems: Capsular Bag Tear
MAUDE report 24496014 ↗InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2026, WHILE CAS WAS ON SITE FOR SURGERY SUPPORT, DOCTOR (B)(6) REPORTED A FULL THICKNESS AK (#2) ON PROCEDURE ID #(B)(4).
Patient problems: Corneal Perforation
MAUDE report 24377100 ↗
Other Ophthalmic Femtosecond Laser devices
- LenSx 8065998162Alcon Laboratories, Inc. · Ophthalmic femtosecond laser599 reports
- CATALYS SYSTEM CATALYS-UOptimedica Corporation · Ophthalmic femtosecond laser576 reports
- WaveLight 8065990941Alcon Laboratories, Inc. · Ophthalmic femtosecond laser460 reports
- LIQUID OPTICS INTERFACE 0180-1201Johnson & Johnson Surgical Vision, Inc. · Ophthalmic femtosecond laser51 reports
- ELITA EL2022Johnson & Johnson Surgical Vision, Inc. · Ophthalmic femtosecond laser31 reports
- LIQUID OPTICS INTERFACE 0180-1401Johnson & Johnson Surgical Vision, Inc. · Ophthalmic femtosecond laser28 reports
- CATALYS SYSTEM CAT PREC LSR SYSJohnson & Johnson Surgical Vision, Inc. · Ophthalmic femtosecond laser14 reports
- INTRALASE TECHNOLOGY PI 0155-1825Johnson & Johnson Surgical Vision, Inc. · Ophthalmic femtosecond laser9 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page