Clareon CCWET0 (UDI 00380652405829)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00380652405829), received between Jan 27, 2023 and Sep 11, 2026 — classified as 16 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Device Dislodged or Dislocated

  A Facility Representative reported following an intraocular lens (IOL) implant procedure, patient experienced myopic surprise. Clinical reason for explant was mentioned as abnormal effective lens position. The IOL was exchanged for unspecified monofocal lens 28 days following the initial implant procedure.Additional information has been requested but is not available at the time of this report.

  Patient problems: Visual Impairment

  MAUDE report 50734472 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  A non healthcare professional reported that, after intraocular lens implantation surgery, the patient experienced poor vision. Hence the lens was explanted and replaced with non-company lens in a secondary procedure. The clinical reason for explant was blurry vision.Additional information has been requested but is not available at the time of this report

  Patient problems: Blurred Vision

  MAUDE report 50690152 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  A non-health care professional reported that following an intraocular lens (IOL) implant procedure, the patient experienced with anisometropia. The lens was exchanged for another lens model 01 month 19 days following the initial procedure.Additional information has been requested but is not available at the time of this report.

  Patient problems: Visual Impairment

  MAUDE report 50155412 ↗
• InjuryJul 3, 2026Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT, FOLLOWING INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT WAS UNHAPPY WITH DISTANCE, NEAR AND INTERMEDIATE VISION. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER MONOFOCAL IOL (INTRAOCULAR LENS) IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS AN UNEXPECTED REDUCTION IN QUALITY OF VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 25704698 ↗
• MalfunctionMay 5, 2026Failure to Deliver

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS STUCK AND SEEMED DRY AND LODGED. LENS WAS REMOVED DURING THE INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 25079776 ↗
• MalfunctionMay 1, 2026Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC ISSUE WAS OBSERVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE HAPTIC TEAR WAS OBSERVED PRIOR TO LOADING. PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25055010 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS NOT SATISFIED WITH VISION. THE LENS WAS EXPLANTED AND EXCHANGED WITH ATIOL LENS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS POST OP MYOPIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 24596917 ↗
• MalfunctionOct 22, 2025Failure to Deliver; Failure to Deliver

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THE LENS GOT STUCK TO THE INSERTER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23356362 ↗
• InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS EXPLANTED IN SECONDARY PROCEDURE DUE TO INTOLERANT LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 22096207 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED AN FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED NIGHT VISION PROBLEMS. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN MONOFOCAL LENS FOLLOWING THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 19919051 ↗
• InjuryJul 9, 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 HAD GLARE AND HALOS DUE TO WHICH HE/SHE WAS UNABLE TO DRIVE AT NIGHT AND HEADACHE. THE IOL WAS EXCHANGED FOR UNSPECIFIED ATIOL LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS DYSPHOTOPSIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Headache; Visual Disturbances

  MAUDE report 19700187 ↗
• InjuryJul 5, 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 PATIENT EXPERIENCED BLURRED VISION FROM 1 FOOT TO 3 FEET AND FROM 5 FEET TO FAR AWAY, ITS VERY BLURRY AND PATIENT RECEIVED UNSPECIFIED TREATMENT, BUT NOTHING CHANGED. POST OPERATIVE MEASURES WERE SAME AS PREOPERATIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING EYECARE PROVIDER GIVEN EYE DROPS OR GLASSES BUT PATIENT ISSUES WERE NOT RESOLVED.

  Patient problems: Blurred Vision

  MAUDE report 19679644 ↗
• InjuryJun 3, 2024Optical Decentration; Optical Decentration

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION, AND SHADOW IMAGES. CLINICAL REASON FOR EXPLANT WAS DECENTERED IOL, AND OVER-CORRECTION. THE IOL WAS EXCHANGED FROM NON TORIC MODEL COMPANY LENS TO TORIC MODEL COMPANY LENS WITH DECREASE OF 2 DIOPTER VALUE, 4 MONTHS 21 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING PATIENT ISSUES RESOLVED AND SURGEON¿S PROGNOSIS WAS EXCELLENT WITH NO HARM.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 19452633 ↗
• InjuryMay 20, 2024Adverse 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 WITH HAZY VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 04 MONTHS 11 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS BEST CORRECTED VISUAL ACUITY. ADDITIONAL INFORMATION WAS RECEIVED, PATIENT ALSO EXPERIENCED WITH MYOPIC SURPRISE AND THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 19350664 ↗
• InjuryApr 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT COULD NOT SEE WELL WITH THE LENS. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS "PATIENT INTOLERANCE". ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 19124687 ↗
• InjuryApr 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY DISTANCE VISION. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS DECENTERED IOL AND REFRACTIVE ERROR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 19030605 ↗
• InjuryMar 13, 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 BLURRED VISION AND GHOSTING. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL FIVE MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 18895458 ↗
• MalfunctionNov 20, 2023Scratched Material; Scratched Material

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENSES WERE IMPLANTED AND EXPLANTED IN THE SAME PROCEDURE SINCE THE LENSES WERE VERY SCRATCHED IN DIFFERENT WAYS. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18171371 ↗
• MalfunctionNov 20, 2023Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENSES WERE IMPLANTED AND EXPLANTED IN THE SAME PROCEDURE SINCE THE LENSES WERE VERY SCRATCHED IN DIFFERENT WAYS. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18171369 ↗
• MalfunctionNov 20, 2023Scratched Material; Scratched Material

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENSES WERE IMPLANTED AND EXPLANTED IN THE SAME PROCEDURE SINCE THE LENSES WERE VERY SCRATCHED IN DIFFERENT WAYS. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18171341 ↗
• MalfunctionOct 14, 2023Device Damaged by Another Device; Device Damaged by Another Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, A SCRATCH WAS NOTED ON THE LENS ONCE IT WAS IN THE EYE. THE LENS HAD TO BE CUT OUT OF THE EYE IN THE SAME PROCEDURE. IN THE SURGEON'S OPINION, DAMAGE IN THE CARTRIDGE CONTRIBUTED THE EVENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17936793 ↗
• InjuryMar 7, 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 BLURRY VISION. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS VISION WAS NOT OPTIMAL/REFRACTIVE SURPRISE. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 16493920 ↗
• InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED HALOS. IT WAS ALSO REPORTED THAT THE PATIENT HAD CONSTANT HORIZONTAL DOUBLE VISION, CAN'T SEE TO READ OR WATCH TV AND CAN¿T EVEN LOOK AT THE MOON IT LOOKS LIKE IT¿S TRYING TO DOUBLE VISION. WAS GIVEN EYEGLASSES TO DRIVE BUT THEY ARE NOT RESOLVING THE DOUBLE VISION AND IS WORST AT NIGHT. HAS HAD YAG LASER WITH NO IMPROVEMENT. ADDITIONAL INFORMATION HAS BEEN RECEIVED CLARIFYING THAT THE PATIENT HAD NEVER EXPERIENCED DOUBLE VISION IN LEFT EYE INSTEAD HAD GLARE AND STREAKS OF LIGHT SYMPTOMS MOSTLY OCCUR AT NIGHT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR THE LEFT EYE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 16254773 ↗