Clareon CNW0T6 (UDI 00380652411202)Recalls & reported problems
Alcon Laboratories, Inc. · CLAREON BLF TORIC · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652411202), received between Aug 28, 2022 and Dec 24, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Failure to Eject1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 24, 2025Product Quality Problem; Product Quality Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS ISSUE UNSPECIFIED AND EXPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23888472 ↗MalfunctionMar 18, 2025Break; Break
A PHYSICIAN REPORTED THAT, DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION, WHILE LOADING THE LENS INTO CARTRIDGE THE LEADING HAPTIC BROKE. THE SURGERY WAS COMPLETED BY USING ANOTHER LENS. NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21630155 ↗MalfunctionAug 28, 2022Failure to Eject; Failure to Eject
A PHYSICIAN REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE LENS INSERTED INTO THE CARTRIDGE AND INSERTED WITH THE INJECTOR, THE PLUNGER WAS ADVANCED FORWARD WITH THE FILLED IOL AS USUAL, BUT SUDDENLY THE IOL WAS SHOT OFF FROM THE CARTRIDGE AND WAS INSERTED INTO THE EYE, THE SURGEON TRIED TO INSERT IOL WITH SLOWLY ROTATING THE PLUNGER, BUT IOL WAS INSERTED BEFORE THE LAST PUSH. SINCE IT DID NOT ENTER IN THE BAG WITH ONE ACTION, IT WAS REPOSITIONED WITH A HOOK. THE SURGERY WAS COMPLETED WITHOUT THE PRODUCT REPLACEMENT. LENS WAS STILL IMPLANTED INTO THE PATIENT'S EYE. NO FURTHER INFORMATION AVAILABLE. ADDITIONAL INFORMATION RECEIVED STATED THAT PATIENT CONDITION AFTER SURGERY IS GOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15307816 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page