Clareon CCWTT3 (UDI 00380652457422)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00380652457422), received between Nov 8, 2022 and Mar 18, 2026 — classified as 18 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Break

  A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE HAPTIC BROKE OFF DURING INSERTION. HENCE THE LENS WAS CUT OUT FROM THE PATIENT'S EYE AND A NEW LENS WAS INSERTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, BACK UP LENS WAS INSERTED WITHOUT ISSUE AND THE PATIENT ISSUE RESOLVED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24632161 ↗
• 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 WAS NOT SATISFIED WITH THE SPECTACLE CORRECTION. THE LENS WAS EXPLANTED AND EXCHANGED FOR THE DIFFERENT MODEL COMPANY LENS. CLINICAL REASON FOR THE EXPLANT WAS MENTIONED AS DYSPHOTOPSIA. ADDITIONAL INFORMATION HA BEEN RECEIVED THAT PATIENT ALSO EXPERIENCED BURNING , STINGING , GLARE AND FATIGUE. HER DISTANCE VISION WAS POOR. AFTER THE REPLACEMENT LENS THERE WAS NO PATIENT IMPACT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Dizziness; Eye Irritation; Visual Disturbances; Visual Impairment

  MAUDE report 22481495 ↗
• InjuryMay 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A NURSE REPORTED THAT FOLLOWING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD DENSE POSTERIOR CAPSULAR OPACIFICATION, GRADE 2 ANTERIOR CAPSULE FIBROSIS AND LENS ROTATION AT FIVE WEEKS POST OPERATION. SHE ALSO SAID AN ISSUE COULD HAVE BEEN CAUSED FROM THE COMPANY CARTRIDGE. ADDITIONAL INFORMATION RECEIVED STATING THAT IOL ROTATION OF 180- 10, DENSE PCO AND GRADE 2 ACF AT FIVE WEEKS POST OPERATION. PATIENT WAS PRESCRIBED OPHTHALMIC EYE DROP AS POSTOPERATIVE MEDICATION CONTAINING COMBINATION OF CORTICOSTEROID, BROAD-SPECTRUM ANTIBIOTIC AND NON-STEROIDAL ANTI-INFLAMMATORY DRUG. YAG (YTTRIUM ALUMINUM GARNET) LASER CAPSULOTOMY PERFORMED. IN THE SURGEON¿S OPINION THE PRODUCT CONTRIBUTE TO THE EVENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE IS FOR LEFT EYE.

  Patient problems: Blurred Vision; Inflammation; Posterior Capsule Opacification

  MAUDE report 22026135 ↗
• InjuryMay 6, 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 IMPLANTATION SURGERY, THE PATIENT WAS UNHAPPY WITH GLARE. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT, THE PATIENT ISSUE WAS RESOLVED, IN THE SURGEON OPINION, THE PROGNOSIS OF THE PATIENT WAS EXCELLENT. THERE WAS NO PATIENT HARM.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Disturbances

  MAUDE report 21970019 ↗
• InjuryApr 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A NURSE REPORTED THAT FOLLOWING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD DENSE POSTERIOR CAPSULAR OPACIFICATION, GRADE 2 ANTERIOR CAPSULE FIBROSIS AND LENS ROTATION AT FIVE WEEKS POST OPERATION. SHE ALSO SAID AN ISSUE COULD HAVE BEEN CAUSED FROM THE COMPANY CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE IS FOR RIGHT EYE.

  Patient problems: Blurred Vision; Inflammation; Posterior Capsule Opacification

  MAUDE report 21797585 ↗
• InjuryFeb 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION. CLINICAL REASON FOR EXPLANT WAS MECHANICAL COMPLICATION. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) MODEL LENS 1 MONTHS 5 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 21445220 ↗
• MalfunctionJan 2, 2025Scratched Material; Scratched Material

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS SCRATCHED AFTER INSPECTION IN EYE AND THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21054992 ↗
• InjuryNov 28, 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 DECREASING VISION. THE LENS WAS EXPLANTED 3 MONTHS FOLLOWING THE INITIAL PROCEDURE.

  Patient problems: Blurred Vision

  MAUDE report 20805834 ↗
• InjurySep 17, 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 SEVERE HALOS & WAVY VISION. THE IOL WAS EXCHANGED FOR THE ANOTHER LENS MODEL 2 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 20238541 ↗
• InjurySep 3, 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 WANTS TO OPTIMIZE DISTANCE VISION WITHOUT LOSING NEAR VISION. THE IOL WAS EXCHANGED FOR NON-COMPANY LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20127232 ↗
• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATING THAT CUSTOMER WAS TOLD THAT THESE LENSES WOULD GIVE A PERFECT VISION, BUT HE DID NOT HAVE THAT WITH THESE LENSES. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO LEFT EYE.

  Patient problems: Visual Impairment

  MAUDE report 19666194 ↗
• InjuryMar 19, 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 DEBILITATING HALOS, BLURRY NEAR AND INTERMEDIATE VISION. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS MULTI-FOCAL INTOLERANCE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THE IOL WAS EXCHANGED FOR ANOTHER COMPANY LENS.

  Patient problems: Blurred Vision; Halo

  MAUDE report 18928859 ↗
• InjuryNov 28, 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 EXPERIENCED HALOS AND GLARE. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS INTOLERABLE DISCS AND PHOTOPSINS IN RIGHT EYE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 18213986 ↗
• InjurySep 22, 2023Application Program Problem: Power Calculation Error; Application Program Problem: Power Calculation Error

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT BALANCE IS OFF DUE TO FLIPPED AXIS ASTIGMATISM. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 14 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANT MENTIONED AS OVERCORRECTED ASTIGMATISM CAUSING ANISOMETROPIA. ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM THE PHYSICIAN, A PATIENT IOL CALCS HAD 0.9 CYL, TOPOGRAPHY 1.4, AND ORA SHOWED BETWEEN 1.24 AND 1.64, ALL BETWEEN 85-95 DEGREES. THE PATIENT IOL IS AT 95, BUT SHE HAS BETWEEN 0.75 AND 1.00 AND THEY LOOK IN THE PHOROPTER AT 170. MEANING THE T3 SURGEON PUT IN COMPLETELY FLIPPED PATIENT AXIS. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND SURGEON HAS MENTIONED ABOUT THE PROGNOSIS AS DIZZINESS DUE TO FLIPPED ASTIGMATISM CORRECTED BY CHANGING THE ASTIGMATISM BY 90 DEGREES.

  Patient problems: Dizziness; Visual Impairment

  MAUDE report 17797627 ↗
• InjuryJul 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED AND REPORTED THAT THE IOL WAS EXCHANGED FOR THE SAME LENS MODEL BUT 0.15 DIOPTER MORE POWER INDICATING THE CORRECT LENS POWER WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: Visual Disturbances

  MAUDE report 17332022 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WORSENED BLURRY VISION AND HALO. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 3 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE WERE 2 FILES ASSOCIATED WITH THIS REPORT. THIS REPORT WAS 1 OF 2.

  Patient problems: Blurred Vision; Halo

  MAUDE report 17080771 ↗
• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED VISUAL DISTURBANCE. THE LENS WAS EXPLANTED AND REPLACED WITH OTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS PATIENT DID NOT LIKE VISION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 16909973 ↗
• InjuryJan 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED SEVERE GLARE AND CONSTANT TROUBLE WITH HALOS. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS GLARE AND HALOS. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 16173972 ↗
• InjuryJan 11, 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 EXPERIENCED DISCOMFORT FROM THE BRIGHTNESS. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. CLINICAL REASON FOR EXPLANT IS VISUAL DISTURBANCE / PHOTOPHOBIA (EXTREME). ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Disturbances

  MAUDE report 16136960 ↗
• InjuryDec 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED RINGS, STARBURST AND WAS CANNOT SEE TO DRIVE AT NIGHT. IT WAS FURTHER REPORTED THAT THE ROAD AHEAD AT NIGHT APPEARS AS PURE WHITE. NEEDS TO ADAPT TO IT AND MIGHT TAKE SAME TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING SEES RINGS DURING DAY AND NIGHT AND IS STILL HAVING PROBLEMS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR THE LEFT EYE.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 15957195 ↗
• MalfunctionNov 8, 2022Defective Device; Defective Device

  A NON-HEALTH CARE PROFESSIONAL REPORTED TWO LENSES THAT WERE DESTROYED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15752491 ↗