Clareon CCW0T6 (UDI 00380652434843)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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380652434843), received between Apr 17, 2026 and Apr 17, 2026 — classified as 1 injury.
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
Patient problems
- Blurred Vision1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem
A NON HEALTH CARE PROFESSIONAL REPORTED A PLANNED EXPLANT WITH PATIENT REASON NOTED TO BE CANNOT SEE WELL AT DISTANCE. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THE PATIENT COULD NOT SEE WELL AT DISTANCE AND COULD ONLY SEE CLEARLY WHEN CLOSE TO AN OBJECT. THE IOL WAS EXPLANTED AND EXCHANGED WITH AN UNSPECIFIED LENS DURING THE SECONDARY IMPLANT PROCEDURE. THERE WAS NO FURTHER IMPACT TO THE PATIENT.
Patient problems: Blurred Vision
MAUDE report 24911450 ↗
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
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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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