Clareon CNA0T3 (REF CNA0T3.200)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
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652398787), received between Jul 11, 2024 and Jul 20, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (2 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
- Device Difficult to Setup or Prepare2
- Failure to Deliver2
- Material Discolored2
- Defective Component1
- Defective Device1
- Failure to Advance1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information3
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 20, 2026Device Difficult to Setup or Prepare
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25875873 ↗MalfunctionAug 5, 2025Failure to Deliver; Material Twisted/Bent; Failure to Deliver; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS NOT ADVANCING OR LOAD AND HAPTIC BENT WAS OBSERVED. THE ISSUE WAS OCCURRED DURING LOADING AND THE PROCEDURE WAS COMPLETED ON SAME DAY. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22716445 ↗MalfunctionJun 10, 2025Failure to Advance; Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT BEFORE SURGERY, THEY NOTICED THAT THE LENS WAS UNABLE TO BE IMPLANTED AS THEY WERE NOT BEING DELIVERED SAFELY BY PLUNGER TIP. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22176000 ↗MalfunctionMay 28, 2025Failure to Deliver; Failure to Deliver
A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE IMPLANT BLOCKED IN INJECTOR. NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 22095672 ↗MalfunctionApr 29, 2025Material Discolored; Material Discolored
A PHYSICIAN REPORTED THAT AFTER IMPLANTATION OF LENS DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE IOL LOOKED BLUE IMMEDIATELY. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. IT WAS UNKNOWN WHETHER THESE FINDINGS DISAPPEARED OR CONTINUED. THE LENS REMAINED IMPLANTED. THERE HAVE BEEN NO REPORTED HEALTH PROBLEMS OR HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE. THERE ARE 224 MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS 137 OF 224.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21926229 ↗MalfunctionApr 28, 2025Material Discolored; Material Discolored
A PHYSICIAN REPORTED THAT AFTER IMPLANTATION OF LENS DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THERE WAS A PROBLEM WITH THE IOL COATING, THE IOL LOOKED BLUE. THE SURGEON WAS CONCERNED THAT THE IOL COATING MAY AFFECT THE VISUAL ACUITY. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21917389 ↗MalfunctionJan 2, 2025Defective Component; Defective Component
A HEALTH CARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE IOL WAS BEING LOADED THE SURGEON WAS NOT COMFORTABLE PROCEEDING WITH THE STRAIGHT HAPTIC. THERE WAS NO PATIENT CONTACT. THE LENS WAS REMOVED FROM PRELOADED DEVICE AND USED COMPANY IOL INJECTOR TO IMPLANT LENS AND LENS REMAINED IN SITU. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21053911 ↗MalfunctionJul 11, 2024Device Difficult to Setup or Prepare; Defective Device; Device Difficult to Setup or Prepare; Defective Device
A HEALTH CARE PROFESSIONAL REPORTED THAT THEY NOTICED A FAULTY LENS, WHICH WAS NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19720188 ↗
Other Intraocular Lens devices
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- 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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