Clareon™ CNWTT3 (UDI 00380652468510)Recalls & reported problems
Alcon Laboratories, Inc. · STERILE UV and Blue Light Filtering Hydrophobic Acrylic Foldable Diffractive Aspheric Toric Posterior Chamber Intraocular Lens · 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 00380652468510), received between Jul 29, 2024 and Oct 23, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Defective Component” (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
- Defective Component1
Patient problems
- Blurred Vision3
- Vitreous Floaters3
- Halo2
- Visual Disturbances2
- Insufficient Information1
- Visual Impairment1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE LENS HAD BEEN REPLACED WITH A DIFFERENT MODEL WITH A DIFFERENT DIOPTER OF COMPANY LENS. YAG HAD BEEN PERFORMED PRIOR TO THE EXPLANT.
Patient problems: Blurred Vision; Visual Impairment; Vitreous Floaters
MAUDE report 23367609 ↗InjurySep 4, 2024Defective Component; Defective Component
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTICS OF THE IOL WERE TORN OFF. THE PLANNED OPERATION WAS COMPLETED BY EXPLANTATION OF THE DAMAGED IOL. THE CURRENT CONDITION OF THE PATIENT WAS APHAKIA AND THE PATIENT WAS NOT HARMED. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT REPEATED OPERATION WAS PERFORMED, THE OPERATION WAS SUCCESSFUL.
Patient problems: Insufficient Information
MAUDE report 20134666 ↗InjuryJul 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED TROUBLE READING ROAD SIGNS, HAD GLARE, HALOS, AND A SPIDER-WEB APPEARANCE IN HER VISION SEVERAL DAYS FOLLOWING THE IMPLANTATION OF EACH EYE. ADDITIONALLY CLAIMS THAT SHE CAN SEE THE EDGE OF HER LENS WHEN SHE LOOKS LEFT (NOT SURE WHICH EYE) AND THE VISION IS 20/20, AND THE IMPLANTING SURGEON AND THEIR OTHER ASSOCIATES HAVE NOT FOUND ANYTHING CLINICAL. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO LEFT EYE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Blurred Vision; Halo; Visual Disturbances; Vitreous Floaters
MAUDE report 19850302 ↗InjuryJul 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED TROUBLE READING ROAD SIGNS, HAD GLARE, HALOS, AND A SPIDER-WEB APPEARANCE IN HER VISION SEVERAL DAYS FOLLOWING THE IMPLANTATION OF EACH EYE. ADDITIONALLY CLAIMS THAT SHE CAN SEE THE EDGE OF HER LENS WHEN SHE LOOKS LEFT (NOT SURE WHICH EYE) AND THE VISION IS 20/20, AND THE IMPLANTING SURGEON AND THEIR OTHER ASSOCIATES HAVE NOT FOUND ANYTHING CLINICAL. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO RIGHT EYE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Blurred Vision; Halo; Visual Disturbances; Vitreous Floaters
MAUDE report 19850267 ↗
Other LENS, INTRAOCULAR, TORIC OPTICS devices
- TECNIS IOL ZCT150Johnson & Johnson Surgical Vision, Inc. · LENS, INTRAOCULAR, TORIC OPTICS1 recall7 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS43 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS36 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS32 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS30 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS29 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS21 reports
- TECNIS IOL DIU150Johnson & Johnson Surgical Vision, Inc. · LENS, INTRAOCULAR, TORIC OPTICS19 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.
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