Clareon CCW0T3 (UDI 00380652431798)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 00380652431798), received between Aug 28, 2024 and Aug 12, 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
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Blurred Vision1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 12, 2026Break
A facility representative reported that during surgery, they noticed that the haptic was brokenAdditional information has been requested and received stating that the haptic was torn off on insertion, noted in the eye. Lens was cut out of the eye and a different lens was implanted. Procedure was completed on the same day. There was no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50222426 ↗InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED BLURRY DISTANCE VISION. CLINICAL REASONS BEING MENTIONED AS OTHER SUBJECTIVE VISUAL DISTURBANCES. THE IOL WAS EXPLANTED AND EXCHANGED FOR A NONCOMPANY LENS IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: Blurred Vision
MAUDE report 25407613 ↗MalfunctionAug 28, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, HALF OF THE IOL WAS TORN. ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED, THE BACK HALF OF THE LENS WAS OBSERVED TO BE TORN. THE PROCEDURE WAS COMPLETED ON SAME DAY WITH OTHER LENS. THERE WAS NO PATIENT HARM. THE CAUSE OF THE TORN LENS IS UNKNOWN TO THE SURGEON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20083588 ↗
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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