Clareon CCW0T3 (UDI 00380652431781)Recalls & reported problems
Alcon Laboratories, Inc. · CLAREON TORIC UVA · 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 00380652431781), received between Aug 17, 2023 and Jul 3, 2026 — classified as 1 injury, 2 malfunctions.
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
- Adverse Event Without Identified Device or Use Problem1
- Failure to Deliver1
- Scratched Material1
Patient problems
- Blurred Vision1
- 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.
MalfunctionJul 3, 2026Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LENS WOULD NOT ADVANCE AND STUCK IN CARTRIDGE.
Patient problems: Insufficient Information
MAUDE report 25704540 ↗InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTH CARE PROFESSIONAL REPORTED THAT AFTER SURGERY, THE PATIENT EXPERIENCED BLURRY VISION WHILE DRIVING ABOUT 15 FEET AND LONGER. PATIENT ALSO STATED THAT CAN SEE EXCELLENT UP CLOSE TO 6 TO 8 FEET, DRIVING STREET SIGNS AND TRAFFIC LIGHTS ARE BLURRY AND ALL OF THIS HAPPENED AFTER SURGERY AND ASKED THAT HE NEED GLASSES FOR DRIVING AND ARE THESE LONG DISTANCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO LEFT EYE.
Patient problems: Blurred Vision
MAUDE report 20842731 ↗MalfunctionAug 17, 2023Scratched Material; Scratched Material
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER THE INTRAOCULAR LENS IMPLANTATION SURGERY, THE PHYSICIAN NOTICED NICK IN THE LENS. HENCE THE LENS WAS REMOVED AND REPLACED IN THE SAME PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THE PROCEDURE WAS COMPLETED ON THE SAME DAY AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17563305 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- 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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