Clareon CNA0T5 (REF CNA0T5.235)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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652399951), received between May 13, 2024 and Jun 5, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Deliver” (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
- Failure to Deliver1
- Failure to Fold1
- Inaccurate Delivery1
Patient problems
- Capsular Bag Tear1
- Eye Injury1
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2025Failure to Deliver; Failure to Deliver
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WOULD NOT ADVANCE. THE SECOND LENS HAD TO BE MANUALLY LOADED TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22151605 ↗InjuryMay 9, 2025Failure to Fold; Failure to Fold
ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE PATIENT HAD TO UNDERGO FURTHER SURGERY FOR VITREOUS INCARCERATION IN THE COUNTER PUNCTURE FOLLOWING CATARACT SURGERY, DURING WHICH POSTERIOR CAPSULAR RUPTURE HAD OCCURRED. THERE WAS NO VITREOUS LEAKAGE AT THE END OF THE FIRST PROCEDURE. THIS OPERATION CONSISTED OF A POSTERIOR VITRECTOMY, WASHING OF THE ANTERIOR CHAMBER, AND DISSECTION OF THE POSTERIOR HYALOID MEMBRANE. THIS SECOND PROCEDURE WAS TOOK PLACE ON (B)(6) 2025. THE PATIENT WAS DOING WELL, AND THE SECOND OPERATION WAS UNEVENTFUL.
Patient problems: Capsular Bag Tear
MAUDE report 21994515 ↗InjuryMay 13, 2024Inaccurate Delivery; Inaccurate Delivery
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON EXTENDED THE WOUND BECAUSE OF THE CARTRIDGE BUT THE LENS CAME OUT OF THE CARTRIDGE BEFORE SURGEON INJECTS THE LENS INSIDE THE PATIENT'S EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Eye Injury
MAUDE report 19296419 ↗
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- 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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