Clareon CCWTT3 (UDI 00380652457446)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00380652457446), received between Nov 4, 2022 and Feb 13, 2026 — classified as 16 injuries, 3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY DISTANCE VISION AND HALOS. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 5 MONTHS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS REFRACTIVE ERROR. ADDITIONAL INFORMATION HAS BEEN REQUESTED YET NO NEW INFORMATION RECEIVED.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 24333373 ↗
• InjuryNov 12, 2025Adverse 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) THE PATIENT EXPERIENCED BLURRY VISION. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 23530022 ↗
• MalfunctionApr 23, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS () IMPLANT PROCEDURE, THE IOL FOUND TO HAVE TORN/ MARK ON IOL. THE IOL WAS REPLACED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 21889610 ↗
• MalfunctionFeb 12, 2025Scratched Material; Scratched Material

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS RECEIVED DAMAGED OUT OF THE BOX AND SURGEON NOTICED A SCRATCH ON THE LENS. LENS WAS IMPLANTED AND EXPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION RECEIVED STATING THAT THERE WAS NO PATIENT HARM. IN SURGEON¿S OPINION MANUFACTURER DEFECT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21363189 ↗
• InjuryJan 20, 2025Adverse 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 IN LEFT EYE, THE PATIENT EXPERIENCED BLURRED VISION. CLINICAL REASON FOR EXPLANT WAS MECHANICAL COMPLICATION OF INTRAOCULAR LENS. THE IOL WAS EXCHANGED FOR UNSPECIFIED ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) 6 MONTHS 6 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 21191381 ↗
• InjuryNov 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE IOL WAS IN GOOD POSITION AT INTENDED AXIS BUT STILL EXPERIENCED RESIDUAL REFRACTIVE ERROR. THE PATIENT WAS UNABLE TO WORK AND COULDN¿T DRIVE. THE LENS WAS ROTATED TO REPOSITION TORIC AND REDUCED CYLINDER AXIS ON 10-JUL-2024. THE LENS WAS EXCHANGED WITH MONOFOCAL LENS ALONG WITH YAG (YTTRIUM ALUMINUM GARNETT). THERE WAS NO PATIENT IMPACT AND SYMPTOMS WERE RESOLVED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 20809234 ↗
• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAD BLURRY VISION. THE LENS WAS EXCHANGED WITH ANOTHER COMPANY IOL, 28 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. PATIENT WAS NOT SATISFIED WITH VISION. THERE WAS NO PATIENT HARM. AS PER SURGEON PRODUCT WAS NOT CONTRIBUTED TO EVENT.

  Patient problems: Blurred Vision

  MAUDE report 20537941 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE IOL WAS EXCHANGED FOR UNSPECIFIED NON-COMPANY LENS. THERE WAS NO PATIENT IMPACT.

  Patient problems: Halo

  MAUDE report 20305126 ↗
• InjurySep 4, 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 HAD MALADAPTATION. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS MODEL 3 MONTHS AND 27 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS MALADAPTATION. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20139485 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION AT ALL DISTANCE. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS BLURRED NEAR VISION AT ALL DISTANCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 19766511 ↗
• InjuryJun 10, 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 HALOS AND GLARE. CLINICAL REASON FOR EXPLANT WAS DYSPHOTOPSIA. THE IOL WAS EXCHANGED FOR MONOFOCAL LENS MODEL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 19498413 ↗
• InjuryMay 15, 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 EXPERIENCED HALOS AT NIGHT MAKING IT DIFFICULT TO DRIVE.THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Halo

  MAUDE report 19320374 ↗
• InjuryMay 7, 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 WITH BLURRY VISION, GLARE. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 02 MONTHS 03 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS DYSPHOTOPSIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 19259320 ↗
• InjuryMar 14, 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 EXPERIENCED BLURRY VISION, HALOS, DULL COLOR VISION AND WAS NOT ABLE TO DRIVE AT NIGHT, DYSPHOTOPSIA. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 12 MONTHS FOLLOWING THE INITIAL PROCEDURE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 18902092 ↗
• InjuryFeb 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED ABOUT AN INTRAOCULAR LENS (IOL) EXPLANT DUE TO PATIENT EXPERIENCED BLURRY VISION. THE CLINICAL REASON WAS REPORTED TO BE RESIDUAL HYPEROPIA. THE IOL WAS REPLACED WITH UNSPECIFIED LENS APPROXIMATELY TWO MONTHS AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 18731194 ↗
• InjurySep 13, 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 NOT SATISFIED WITH RESULTS OF EYE. THE PATIENT STATES, THE VISION HAS BEEN SLOW TO RECOVER AND NOT AS GOOD AS BEFORE SURGERY. THE PATIENT IS ALSO TREATED FOR DRY EYE CONDITIONS. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT WAS TREATED WITH LUBRICANT EYE DROPS AND OINTMENT.

  Patient problems: Dry Eye(s); Visual Impairment

  MAUDE report 17734763 ↗
• InjuryAug 1, 2023Adverse 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 WAS NOT HAPPY WITH THE VISION, CLINICAL REASON BEING PRESBYOPIA . THE IOL WAS EXPLANTED AND EXCHANGED FOR A NON COMPANY LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 17433825 ↗
• MalfunctionNov 16, 2022Crack; Defective Component; Crack; Defective Component

  A PHYSICIAN REPORTED THAT THE THERE WAS A LEADING HAPTIC LOADING ISSUE AND PERIPHERAL CRACKS BELIEVED TO BE FROM THE INSERTER¿S PLUNGER. ADDITIONAL INFORMATION WILL BE REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15805367 ↗
• InjuryNov 4, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION HAS BEEN RECEIVED. AND STATED THAT, THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE.

  Patient problems: Visual Impairment

  MAUDE report 15732907 ↗