Clareon CCWTT4 (UDI 00380652457934)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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652457934), received between Jul 1, 2024 and Jul 11, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Malposition of Device” (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 Problem3
- Malposition of Device1
Patient problems
- Blurred Vision2
- Eye Pain1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Visual Disturbances1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE HALOS AND CANNOT FUNCTION AT NIGHT TO DRIVE. CLINICAL REASON IS PATIENT EXPERIENCING POSITIVE DYSPHOTOPSIA. THE IOL WAS PLANNED TO EXCHANGED FOR TORIC MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Disturbances
MAUDE report 22481361 ↗InjuryJan 13, 2025Malposition of Device; Malposition of Device
ADDITIONAL INFORMATION HAVE RECEIVED IT STATES THAT AFTER THE LENS IMPLANTATION IN POST OPERATIVE DAY NOTICED THAT THE LENS WAS DECENTERED SO, THEY EXCHANGED THE LENS AND PATIENT'S ISSUES RESOLVED. NO PATIENT IMPACT WAS REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21136471 ↗InjuryOct 11, 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 HAD MALADAPTATION. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER UNSPECIFIED LENS IN A SECONDARY PROCEDURE. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 20425806 ↗InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD WAXY QUALITY OF VISION; POOR CONTRAST; COULD NOT SEE ADEQUATELY IN DIM LIGHT. THE PATIENT ALSO HAD ASTHENOPIA FROM MULTIFOCAL OPTICS. THE LENS EXPLANTATION WAS PLANNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS. THE PATIENT HAD POOR QUALITY OF VISION. SURGERY WAS PERFECT. ISSUE WAS WITH QUALITY OF VISION RELATED TO MULTIFOCAL OPTICS.
Patient problems: Blurred Vision; Eye Pain
MAUDE report 19643566 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page