Clareon CCWET0 (UDI 00380652405836)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00380652405836), received between Jan 20, 2023 and Jul 5, 2026 — classified as 14 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (3 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.

• InjuryJul 5, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS HAVING BLURRED VISION. CLINICAL REASON IS PATIENT EXPERIENCING DYSPHOTOPSIA. THE IOL WAS EXCHANGED FOR MONOFOCAL INTRA OCULAR LENS 2 MONTHS 2 WEEKS 2 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 25712636 ↗
• MalfunctionJun 5, 2026Break

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, HAPTIC WAS BROKEN DURING LOADING AND THERE WAS NO CONTACT WITH THE PATIENT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25407631 ↗
• InjuryApr 16, 2026Use of Incorrect Control/Treatment Settings; Product Quality Problem

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO UNSPECIFIED ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information; Visual Impairment

  MAUDE report 24899968 ↗
• MalfunctionDec 9, 2025Scratched Material; Scratched Material

  ADDITIONAL INFORMATION WAS REQUESTED; THERE WAS NO PATIENT CONTACT AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY.

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

  MAUDE report 23757337 ↗
• MalfunctionAug 26, 2025Failure to Deliver; Failure to Deliver

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS AN ISSUES WITH DEPLOYING LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22893316 ↗
• InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DECREASED VISION. CLINICAL REASON BEING MENTIONED AS EXCHANGE FOR SAME LENS, DIFFERENT POWER AND REFRACTIVE SURPRISE. THE IOL WAS EXPLANTED AND EXCHANGED WITH AN UNKNOWN ATIOL (ADVANCED TECHNOLOGY INTRAOCULAR LENS) IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 22565026 ↗
• InjuryJul 7, 2025Adverse 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 GLARE AND HALO. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS. CLINICAL REASON FOR EXPLANT WAS ALSO MENTIONED AS GLARE AND HALO. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THE LENS WAS REPLACED WITH NON-COMPANY LENS.

  Patient problems: Visual Disturbances

  MAUDE report 22412835 ↗
• InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WITH POOR VISUAL OUTCOME. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 01 YEAR 09 MONTHS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS GLARE AND HALO. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 20914363 ↗
• InjuryMay 30, 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. PATIENT REASON AND CLINICAL REASON FOR EXPLANT WAS BLURRY VISION. THE IOL WAS EXCHANGED FOR NON-COMPANY STANDARD MONOFOCAL LENS MODEL 2 MONTHS 9 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 19423851 ↗
• InjuryJan 10, 2024Defective Component; Defective Component

  A FACILITY REPRESENTATIVE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, A HAPTIC WAS BISECTED AND BROKEN OFF. THE WOUND WAS ENLARGED, MORE VISCOELASTIC WAS ADDED, AND THE LENS WAS PLACED INTO THE ANTERIOR CHAMBER. THE DETACHED HAPTIC WAS REMOVED, AND THE IOL WAS CUT AND REMOVED USING A LENS CUTTER. A NEW LENS WITH THE SAME POWER WAS THEN INSERTED INTO THE INTACT CAPSULAR BAG. AFTER IRRIGATION AND ASPIRATION OF THE VISCOELASTIC, THE FOLDED HAPTICS WERE EXPANDED TO FILL THE CAPSULAR BAG. THE LENS WAS OBSERVED TO BE WELL-POSITIONED AND CENTERED ON THE VISUAL AXIS, WITH NO COMPLICATIONS INVOLVING PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN RECEIVED. THERE WAS NO PATIENT HAM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18482780 ↗
• InjuryJan 1, 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 DISTANCE VISION AND WAS UNABLE TO READ. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 2 MONTHS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS PATIENT AIMED FOR DISTANCE VISION BUT ENDED UP 1 DIOPTER MYOPIC.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 18423190 ↗
• InjuryDec 18, 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 HAD DECREASED VISUAL ACUITY, GLARE, NIGHT DRIVING ISSUES, HEADACHES, EYE STRAIN. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision; Eye Pain; Headache; Visual Disturbances

  MAUDE report 18345525 ↗
• InjuryDec 6, 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 EXPERIENCED BLURRY VISION AND HALOS. CLINICAL REASON BEING RESIDUAL REFRACTIVE ISSUES. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. THERE ARE OTHER MEDICAL REPORTS ASSOCIATED WITH THIS FILE. THIS IS 4 OF 13. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Halo; Visual Impairment

  MAUDE report 18273084 ↗
• MalfunctionNov 7, 2023Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INJECTOR WAS SCRATCHING LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18083078 ↗
• MalfunctionAug 21, 2023Crack; Crack

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE LENS WAS CRACKED AND TRAILING HAPTIC WAS BENT. THE PROCEDURE WAS COMPLETED WITH REPLACEMENT LENS DURING THE INITIAL PROCEDURE. THERE WAS PATIENT CONTACT WITH THE LENS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED THAT NO PATIENT HARM REPORTED. THE SYMPTOMS HAS BEEN RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17583720 ↗
• InjuryAug 8, 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 THE PATIENT VISION WAS STILL FUZZY, PATIENT WAS SEEING SHADOWS BEHIND LETTERS AND HAD BLURRY VISION. THE LENS WAS REMOVED AND REPLACED WITH NON-COMPANY LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS HYPEROPIC MISS. ADDITIONAL INFORMATION RECEIVED STATED THAT PATIENT'S RIGHT EYE WAS IMPACTED AND PATIENT'S ISSUES HAVE BEEN RESOLVED.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 17481264 ↗
• InjuryApr 4, 2023Adverse 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 LENS WAS EXPLANTED POST LASIK. THERE WAS NO PATIENT HARM AND PATIENT ISSUE RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16676515 ↗
• InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT'S VISION WAS WORSE THEN PRIOR TO SURGERY. THE LENS WAS EXPLANTED AND REPLACED WITH A MONOFOCAL LENS 2 MONTHS AFTER THE INITIAL PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS POOR DISTANCE AND NEAR VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE PATIENT WAS NOT SEEING WELL AT A DISTANCE OR NEAR. LIMBAL RELAXING INCISIONS PERFORMED BUT HER VISION WAS ONLY SLIGHTLY IMPROVED. THE PATIENT WAS STILL STRUGGLING WITH NEAR TASKS AS WELL AS COMPUTER, SO THE LENS EXPLANT WAS PERFORMED. THE SURGEON'S PROGNOSIS WAS GOOD.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 16545029 ↗
• MalfunctionMar 8, 2023Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL FOUND TO HAVE SCRATCHED AFTER INSERTION INTO THE EYE. IOL WAS REMOVED AND REPLACED WITH A NEW IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16500811 ↗
• InjuryMar 1, 2023Application Program Problem: Power Calculation Error; Defective Device; Application Program Problem: Power Calculation Error; Defective Device

  A PHYSICIAN REPORTED THAT FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT NEAR VISION STARTED DECLINING. THE PHYSICIAN PERFORMED IOL EXCHANGE DUE TO HAVING A HYPEROPIC RESULT AND HAVING IRREGULAR TOPOGRAPHY TO DO LASER PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 16460462 ↗
• MalfunctionJan 20, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE EXPERIENCED DEBRIS AND REMOVED THE DEBRIS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16214946 ↗