Clareon™ CCA0T0 (UDI 00380652397490)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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652397490), received between May 3, 2024 and Feb 9, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Device Difficult to Setup or Prepare1
- Failure to Deliver1
Patient problems
- Capsular Bag Tear1
- Insufficient Information1
- 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.
MalfunctionFeb 9, 2026Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) DEVICE DID NOT DELIVER CORRECTLY. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, DURING THE PHACO PROCEDURE ISSUE WITH COMPLAINT PRODUCT WAS NOTICED. THE TIP OF THE PRE-LOADED DEVICE IN CONTACT WITH THE PATIENT HOWEVER THERE WAS NO IMPACT TO THE PATIENT. THE ORIGINALLY SCHEDULED PROCEDURE COMPLETED ON THE SAME DAY BY USING THE ALTERNATE LENS. IN THE SURGEON¿S OPINION, THE INJECTOR CAUSED THE EVENT. THE PATIENT'S ISSUES HAD BEEN RESOLVED. THE PATIENT WAS DOING FINE AT THE TIME OF REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24293325 ↗MalfunctionDec 31, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TRAILING HAPTIC DID NOT FOLD AND GOT WEDGED BETWEEN THE PLUNGER AND NOZZLE. THE LENS WAS STILL IMPLANTED IN THE PATIENT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23932669 ↗InjuryMay 3, 2024Break; Break
A FACILITY REPRESENTATIVE REPORTED THAT WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) HAPTIC WAS BROKEN OR TORN. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE PATIENTS CAPSULE WAS TORN.
Patient problems: Capsular Bag Tear
MAUDE report 19238446 ↗
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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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