Clareon CNW0T3 (UDI 00380652409759)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
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652409759), received between Sep 25, 2023 and Jul 27, 2026 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (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
- Scratched Material2
- Adverse Event Without Identified Device or Use Problem1
- Failure to Unfold or Unwrap1
- Material Twisted/Bent1
Patient problems
- Insufficient Information2
- Blurred Vision1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 27, 2026Failure to Unfold or Unwrap; Material Twisted/Bent
Patient problems: Insufficient Information
MAUDE report 50035836 ↗MalfunctionMay 19, 2026Scratched Material
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT THE LENS HAS SCRATCH OR DEBRIS, BUT SURGEON COULD NOT REMOVE. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THERE WAS NO FURTHER PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25216004 ↗InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS NOT SATISFIED WITH THE VISION. THE IOL EXCHANGE WAS PLANNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE LENS WAS EXCHANGED FOR UNSPECIFIED LENS IN A SECONDARY PROCEDURE. THE SURGERY WENT WELL, AND A POST-OPERATIVE APPOINTMENT WAS SCHEDULED.
Patient problems: Blurred Vision
MAUDE report 23788959 ↗MalfunctionSep 25, 2023Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT DURING SURGERY, THEY NOTICED MARKS ON LENS WHEN HE IMPLANTED FROM INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT, MARK SEEN ON OPTIC AND HAPTIC, THE MARKS ON THE IOLS WERE SEEN POST IMPLANTATION OF THE IOLS. THUS SURGEON HAD NOT EXPLANTED THE IOLS. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS EVENT. THIS FILE IS 1 OF 2.
Patient problems: Insufficient Information
MAUDE report 17807236 ↗
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
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- 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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