Clareon CCWTT4 (UDI 00380652457903)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
- 7
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652457903), received between Jan 15, 2023 and Jun 12, 2025 — classified as 5 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Crack” (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 Problem5
- Crack1
- Malposition of Device1
- Scratched Material1
Patient problems
- Visual Disturbances5
- Blurred Vision2
- Insufficient Information2
- Halo1
- Visual Impairment1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE PATIENT EXPERIENCED GLARE, HAD TROUBLE READING FINE PRINT. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER TORIC LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS DYSPHOTOPSIA SECONDARY TO IOL.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 22196327 ↗InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION AT DISTANCE AND NEAR AND POSITIVE AND NEGATIVE DYSPHOTOPSIA. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS BEST CORRECTED VISUAL ACUITY 20/30 DYSPHOTOSIAS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 20508416 ↗MalfunctionNov 6, 2023Scratched Material; Scratched Material
A NON-HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF LENS WAS SCRATCHED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHICH WAS NOTED AFTER IMPLANTATION. LENS WAS EXPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.
Patient problems: Insufficient Information
MAUDE report 18073468 ↗InjuryNov 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT WAS HAVING SUCH BAD RINGS AND GLARE IN HER VISION AT NIGHT. THE PATIENT WAS NOT ABLE TO DRIVE. THE PATIENT WAS HAVING THESE ISSUES FOR OVER AN YEAR AND IT DD NOT GET BETTER. THEIR OPTOMETRIST TRIED GIVING HER GLASSES, BUT THAT DID NOT HELP. THE PATIENT WAS NOT WILLING TO DO AN INTRAOCULAR LENS (IOL) EXCHANGE BUT THEY WANTED TO FIND SOLUTIONS TO THIS ISSUE. THE PATIENT WAS HAPPY WITH THE OTHER BENEFITS OF THE LENSES. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.
Patient problems: Visual Disturbances
MAUDE report 18066037 ↗InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT WAS DISSATISFIED WITH LEVEL OF VISUAL CLARITY, BOTHER BY HALOS. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. CLINICAL REASON FOR EXPLANT VISUAL HALOS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Halo; Visual Disturbances
MAUDE report 17938443 ↗MalfunctionMay 3, 2023Crack; Crack
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT A LENS WAS CRACKED AND WAS WASTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16862743 ↗InjuryJan 15, 2023Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE CLINICAL REASON FOR THE EXPLANT WAS LENS DECENTERED.
Patient problems: Visual Disturbances; Visual Impairment
MAUDE report 16171660 ↗
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