Clareon CNA0T5 (REF CNA0T5.220)Recalls & reported problems
Alcon Laboratories, Inc. · CLAREON TORIC AUTONOME · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652399920), received between May 27, 2025 and Oct 23, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Advance2
- Failure to Deliver2
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 23, 2025Failure to Advance; Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE PLUNGER OVER RODE THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23369514 ↗MalfunctionAug 25, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, INJECTOR WAS NOT FUNCTIONED PROPERLY. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THE LENS DID NOT ADVANCE AFTER PRIMING. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22882259 ↗MalfunctionJul 30, 2025Failure to Deliver; Failure to Deliver
A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DIDN'T COME OUT ALL DURING INSERTION. A PART OF IOL WAS INSERTED INTO THE EYE BUT WAS NOT COMPLETED. THE LENS WAS EXCHANGED WITH ANOTHER LENS OF SAME MODEL BUT DIFFERENT LOT NUMBER AND THE SURGERY WAS PERFORMED AND COMPLETED ON THE SAME DAY.
Patient problems: Insufficient Information
MAUDE report 22662954 ↗MalfunctionMay 27, 2025Failure to Advance; Failure to Advance
A PHARMACIST REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IMPLANT STUCK IN INJECTOR. THE PATIENT IMPACT WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22087145 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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