Clareon™ CCA0T0 (UDI 00380652397179)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 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652397179), received between Oct 26, 2023 and Sep 24, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (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 Advance1
- Failure to Deliver1
- Material Deformation1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Material Deformation
A physician reported that subsurface nano glistening (SSNGs) was observed after intraocular lens implantation surgery.According to the additional information received, there was no visual impact to the patient.There are multiple medical reports associated with same event. This is 19 of 29.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884531 ↗MalfunctionApr 2, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, INJECTOR FAILED, WOULDN'T PROGRESS LENS FORWARD. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21754028 ↗MalfunctionOct 26, 2023Failure to Advance; Failure to Advance
A NURSE REPORTED THAT, DURING THE IOL INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, INJECTOR FAILURE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18014054 ↗
Other intraocular lens devices
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- 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.
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