Clareon CCWTT6 (UDI 00380652458962)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon PanOptix 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 00380652458962), received between Oct 3, 2024 and Oct 3, 2024 — 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
- Headache1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 3, 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 FLICKERING, HEADACHES AND THE PATIENT ALSO STATED THAT UNABLE TO SEE. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN LENS FOLLOWING THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE IOL WAS EXPLANTED AND EXCHANGED WITH A NON-COMPANY LENS FOLLOWING THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE BEFORE BEING DIAGNOSED WITH CATARACTS, THE PATIENT HAD NO NOTICEABLE VISION ISSUES. DOCTOR RECOMMENDED MULTIFOCAL LENS, BUT AFTER SURGERY, FOR THE NEXT FIVE PLUS MONTHS, PATIENT COULD NOT SEE CLEARLY. ALSO, THE PATIENT COULD NOT DEFINE COLORS AND DIFFERENTIATE BETWEEN COLORS SUCH AS A GREEN BACKGROUND AND A RED EIGHTEEN WHEEL TRUCK THAT ALMOST HIT HIM IF PATIENT COULD NOT SEE IT. PROBLEMS STARTED IMMEDIATELY AND NEVER SUBSIDED AND ALSO HAD FLASHES AND CONSTANT HEADACHES.
Patient problems: Headache; Visual Disturbances; Visual Impairment
MAUDE report 20357438 ↗
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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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