Clareon™ CCA0T0 (UDI 00380652397452)Recalls & reported problems
Alcon Laboratories, Inc. · STERILE UV Absorbing Hydrophobic Acrylic Foldable Aspheric Posterior Chamber Intraocular Lens with the AutonoMe™ Automated Pre-loaded Delivery System · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652397452), received between May 4, 2022 and Feb 16, 2026 — classified as 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Difficult to Setup or Prepare1
- Failure to Deliver1
- Failure to Fold1
- Failure to Unfold or Unwrap1
- Inaccurate Delivery1
- Unintended Ejection1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information2
- Blurred Vision1
- Visual Impairment1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 16, 2026Device Difficult to Setup or Prepare; Failure to Deliver
A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE TRAILING HAPTIC WAS STUCK TO THE PLUNGER AND IT WOULD NOT ADVANCE FAR ENOUGH TO BE RELEASED INTO THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT
Patient problems: Insufficient Information
MAUDE report 24344836 ↗MalfunctionNov 10, 2025Inaccurate Delivery; Inaccurate Delivery
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THE DOCTOR ATTEMPTED TO ADVANCE THE IOL, AND THE IMPLANT WAS PUSHED OUT THROUGH THE TIP OF THE INSERTER. THERE WAS PATIENT CONTACT REPORTED IN RIGHT EYE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITH UNSPECIFIED REPLACEMENT LENS AND THERE WAS NO IMPACT TO THE PATIENT ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23510103 ↗MalfunctionJul 1, 2025Failure to Fold; Failure to Fold
A FACILITY REPRESENTATIVE REPORTED WITH DESCRIPTION OF LENS LOADING ERROR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22370797 ↗MalfunctionMay 8, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TRAILING HAPTIC WAS STUCK TO POSTERIOR SIDE OF OPTIC NOTICED UPON INSERTION IN THE EYE. HAPTIC WAS RELEASED FROM THE OPTIC. LENS REMAINS IMPLANTED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21986327 ↗MalfunctionApr 21, 2023Unintended Ejection; Unintended Ejection
A SURGEON REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS ADVANCED TOO EARLY AND BECAME STUCK IN THE INCISION, THE SURGEON REMOVED THE LENS FROM THE WOUND AND USED A NEW LENS. THERE WAS NO PATIENT INJURY. THE INCISION WAS NOT ENLARGED AND NO SUTURE WAS NECESSARY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16784055 ↗InjuryMay 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED UNEXPECTED OUTCOMES, WANTS DISTANT VISION AND LENS POWER ISSUE. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 14275999 ↗
Other intraocular lens devices
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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