Clareon CNA0T5 (REF CNA0T5.225)Recalls & reported problems
Alcon Laboratories, Inc. · CLAREON TORIC AUTONOME · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380652399937), received between Mar 12, 2025 and Sep 15, 2026 — classified as 1 injury, 11 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Advance3
- Failure to Deliver3
- Inaccurate Delivery3
- Material Twisted/Bent2
- Activation Problem1
- Adverse Event Without Identified Device or Use Problem1
- Device Difficult to Setup or Prepare1
Patient problems
- Insufficient Information9
- No Clinical Signs, Symptoms or Conditions3
- Capsular Bag Tear1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Failure to Deliver
A healthcare professional reported that during the intraocular lens (IOL) implantation procedure, the lens did not load properly.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50772851 ↗MalfunctionMay 13, 2026Inaccurate Delivery
A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PROCEDURE WAS PERFORMED WITH A 2.4MM CORNEAL INCISION, AND ALTHOUGH THE LENS WAS INSERTED USING THE WOUND ASSIST METHOD, THE IMPLANT COULD NOT BE SUCCESSFULLY PERFORMED. IT WAS ALSO STATED THAT BOTH THE PRIMARY AND BACKUP LENSES COULD NOT BE SUCCESSFULLY IMPLANTED IN TWO CONSECUTIVE ATTEMPT AND THE LENSES ARE NOT INSIDE THE EYE. SINCE THE LENSES COULD NOT BE INSERTED A BACKUP LENS NON COMPANY WAS USED IN THE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25161926 ↗MalfunctionMay 13, 2026Inaccurate Delivery
A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PROCEDURE WAS PERFORMED WITH A 2.4MM CORNEAL INCISION, AND ALTHOUGH THE LENS WAS INSERTED USING THE WOUND ASSIST METHOD, THE IMPLANT COULD NOT BE SUCCESSFULLY PERFORMED. IT WAS ALSO STATED THAT BOTH THE PRIMARY AND BACKUP LENSES COULD NOT BE SUCCESSFULLY IMPLANTED IN TWO CONSECUTIVE ATTEMPT AND THE LENSES ARE NOT INSIDE THE EYE. SINCE THE LENSES COULD NOT BE INSERTED A BACKUP LENS NON COMPANY WAS USED IN THE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25161924 ↗MalfunctionMay 11, 2026Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) PROCEDURE LEADING HAPTIC WAS FAILED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25135352 ↗InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS WAS INITIALLY IMPLANTED; HOWEVER, A POSTERIOR CAPSULAR TEAR OCCURRED, NECESSITATING EXPLANTATION OF THE LENS AND REPLACEMENT WITH A THREE-PIECE IOL. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Capsular Bag Tear
MAUDE report 24292125 ↗MalfunctionJan 12, 2026Failure to Deliver
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF MISFIRE.
Patient problems: Insufficient Information
MAUDE report 24034041 ↗MalfunctionJan 1, 2026Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT THE PLUNGER DID NOT ENGAGE WITH IOL DURING DELIVERY. PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23941047 ↗MalfunctionDec 19, 2025Material Twisted/Bent; Material Twisted/Bent
A PHYSICIAN REPORTED WITH A DESCRIPTION OF LEADING HAPTIC DID NOT FOLD. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23848344 ↗MalfunctionDec 11, 2025Failure to Advance; Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER HAD PASSED OVER THE LENS, ANOTHER LENS WAS TAKEN AND WHEN SURGEON TRIED TO PUT IT IN PATIENT EYE, PLUNGER DID NOT GO UP AND THE LENS DID NOT ADVANCE. THE SURGERY WAS COMPLETED ON THE SAME DAY USING THE SAME LENS. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION RECEIVED AND STATING THAT THE IOL WAS SUCCESSFULLY INSERTED BY ADJUSTING THE PLUNGER DIRECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23777136 ↗MalfunctionDec 11, 2025Failure to Deliver; Failure to Advance; Failure to Deliver; Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER HAD PASSED OVER THE LENS, ANOTHER LENS WAS TAKEN AND WHEN SURGEON TRIED TO PUT IT IN PATIENT EYE, PLUNGER DID NOT GO UP AND THE LENS DID NOT ADVANCE. THE SURGERY WAS COMPLETED ON THE SAME DAY USING THE SAME LENS. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION RECEIVED AND STATING THAT THE IOL WAS SUCCESSFULLY INSERTED BY ADJUSTING THE PLUNGER DIRECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23777132 ↗MalfunctionOct 30, 2025Inaccurate Delivery; Activation Problem; Inaccurate Delivery; Activation Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION THE INTRAOCULAR LENS (IOL) CAME OUT TOO EARLY. BECAME STUCK IN WOUND. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH ANOTHER UNSPECIFIED LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23426871 ↗MalfunctionMar 12, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, BEFORE THE CATARACT WITH INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS FAILED AND NOT INSERTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21583777 ↗
Other Intraocular Lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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