Clareon CCWTT3 (UDI 00380652457569)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon PanOptix Toric UVA · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652457569), received between May 2, 2025 and Jun 22, 2026 — classified as 3 injuries.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Blurred Vision2
- Visual Disturbances2
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem
A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED VISION IS OFF AND A LOT OF DIFFICULTY READING. CLINICAL REASON BEING HYPEROPIC SURPRISE. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS(ATIOL) FOLLOWING 11 MONTHS, 29 DAYS THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Visual Impairment
MAUDE report 25575204 ↗InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BOTHERED RINGS. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS MALADAPTATION TO LENS AND EXCHANGED FOR THE ANOTHER COMPANY LENS MODEL 3 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 21951665 ↗InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BOTHERED RINGS. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 03 MONTHS 15 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS MALADAPTATION TO LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS IS 2 OF 2.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 21951083 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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