Clareon™ CNWTT5 (UDI 00380652469654)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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652469654), received between Jun 8, 2023 and Feb 20, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (2 reports).
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
- Scratched Material2
- Device Dislodged or Dislocated1
Patient problems
- Blurred Vision1
- Capsular Bag Tear1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Prolapse1
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 20, 2026Scratched Material
A HEALTHCARE PROFESSIONAL STATED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, SURGEON FOUND THAT LENS WAS SCRATCHED AFTER THE SURGERY. SURGEON CONFIRMED THAT DURING LENS IMPLANTATION, THE FORCEPS WAS NOT TOUCH WITH OPTIC AND NO MARK ON THE LENS BEFORE IMPLANTATION. THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT PATIENT DID NOT OBSERVE ANY DETERIORATION.
Patient problems: Insufficient Information
MAUDE report 24401459 ↗MalfunctionJul 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED HAZY VISION AT NIGHT. A SECONDARY PROCEDURE WAS PLANNED TO REPLACE THE LENS WITH A MONOFOCAL IOL. THE CLINICAL REASON FOR THE PLANNED EXPLANT WAS ROTATION OF THE TORIC IMPLANT. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT EXPERIENCED POSTERIOR CAPSULAR RUPTURE, VITREOUS LOSS, AND RESIDUAL ASTIGMATISM. THE PATIENT CONTINUES TO HAVE PERSISTENT ASTIGMATISM. VISUAL ACUITY IS 20/20 WITH CORRECTION, ATTRIBUTED TO THE RESIDUAL ASTIGMATISM FOLLOWING THE EXPLANT OF THE TORIC LENS. THE LENS WAS REPLACED WITH A 22.5D MONOFOCAL LENS FROM THE SAME MANUFACTURER.
Patient problems: Blurred Vision; Capsular Bag Tear; Prolapse; Visual Impairment
MAUDE report 22642841 ↗MalfunctionJun 8, 2023Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT THE SETTING WAS PERFORMED AS USUAL, AND WHEN THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE EYE, A SCRATCH WAS FOUND IN THE IOL OPTIC. SINCE IT WAS NOT A MULTIFOCAL AREA, IT WAS JUDGED THAT THERE WAS NO PROBLEM, AND THE IOL WAS IMPLANTED AS IT WAS. THE SURGERY WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17086106 ↗
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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