Clareon CNWET0 (UDI 00380652405287)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00380652405287), received between Feb 10, 2023 and Jul 27, 2026 — classified as 12 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  A facility representative reported that following an intraocular lens (IOL) implant procedure, lens was explanted at secondary procedure due to patient experienced poor vision. The clinical reason for explant was reported to be unexpected myopia. The IOL was replaced with unspecified lens two months 23 days after initial procedure.Additional information has been requested but is not available at the time of this report.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 50033558 ↗
• MalfunctionApr 10, 2026Device Damaged by Another Device

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS SCRATCHED WHILE BEING LOADED INTO INJECTOR. THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE LENS WAS NOTED TO BE SCRATCHED IN THE OPTIC AFTER IT HAD BEEN INJECTED INTO THE PATIENT'S EYE THROUGH A COMPANY CARTRIDGE USING THE COMPANY INSERTER. IN THE SURGEON¿S OPINION, THEY WAS UNSURE IF TECHNICIAN'S IMPROPER LOADING TECHNIQUE OR INJECTOR MALFUNCTION. HENCE THEY HAVE CUT THE LENS IN HALF AND REMOVED IT FROM THE EYE DURING INITIAL PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 24845538 ↗
• InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT IN THE SURGEONS OPINION PRODUCT NOT CONTRIBUTED TO EVENT, PRIOR LASIK SURGERY CONTRIBUTED TO EVENT. THE LENS WAS REPLACED WITH COMPANY SAME MODEL LENS BUT 3 DIOPTER VALUE LESS. THE PATIENT'S ISSUES WAS RESOLVED. AS IOL WAS EXCHANGED FOR THE COMPANY SAME LENS MODEL BUT THREE DIOPTER LESS POWER INDICATING THE CORRECT LENS POWER WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 23943461 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT EXPERIENCED BLURRED VISION AND WAS UNABLE TO FOCUS. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS MECHANICAL COMPLICATION DUE TO OCULAR PROSTHESIS. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 23366410 ↗
• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING A PHAKIC INTRAOCULAR LENS IOL IMPLANT PROCEDURE, A SPOT APPEARED IN FRONT OF THE LEFT EYE THE DAY AFTER THE OPERATION. VISUAL ACUITY DECREASED TO 0.2. A COURSE OF ANTI-INFLAMMATORY AND DECONGESTANT THERAPY WAS PERFORMED. ON 30 MAY 2025, VISUAL ACUITY IMPROVED TO 0.6. OPTICAL COHERENCE TOMOGRAPHY (OCT) SHOWED A MICRO-DETACHMENT OF THE NEUROEPITHELIUM IN THE MACULA. ON 20 JUNE 2025, VISUAL ACUITY OF THE LEFT EYE WAS NOTED TO BE 1.0. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Retinal Detachment; Visual Disturbances

  MAUDE report 22529021 ↗
• InjuryJun 20, 2025Scratched Material; Material Split, Cut or Torn; Scratched Material; Material Split, Cut or Torn

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS IMPLANT PROCEDURE, THE LENS ENTERED THE EYE WITH A PIECE OF THE HAPTIC BROKEN OFF AND COMPLETELY SCRATCHED. A QUADRANT WAS BROKEN OFF, AND THE REMAINING LENS WAS REMOVED FROM THE EYE. THREE STITCHES OF 10.0 NYLON WERE ADMINISTERED. THE SURGERY WAS NOT COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Eye Injury; Insufficient Information

  MAUDE report 22296709 ↗
• MalfunctionMay 6, 2025Break; Failure to Unfold or Unwrap; Break; Failure to Unfold or Unwrap

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE HAPTIC BROKE OFF AFTER IMPLANTING THE LENS IN THE EYE. ADDITIONAL INFORMATION WAS RECEIVE STATING THAT, UPON INSERTION OF THE LENS THE HAPTICS STUCK TOGETHER BUT AS THEY UNFOLDED THE TRAILING HAPTIC WAS NOT CONNECTED THE LENS. IT WAS SITTING ON THE OPTIC. AS THE SURGEON TRIED TO REMOVE THE LENS THE LEADING HAPTIC CAME OFF AND THE SURGEON THEN HAD TO REMOVE THE LENS AND REPLACE IT WITH ANOTHER ONE DURING THE SAME SURGERY. THERE WAS NO PATIENT HARM. IN THE SURGEON¿S OPINION, PROGNOSIS OF THE PATIENT WAS GOOD.

  Patient problems: Insufficient Information

  MAUDE report 21969702 ↗
• MalfunctionMar 20, 2025Break; Break

  A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF BROKEN HAPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21652743 ↗
• InjuryMar 10, 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 PROGRESSIVELY SEEING LESS FOR DISTANCE VISION, GLARE AT NIGHT AND DUSK AND CAN ONLY SEE APPROXIMATELY 8 FEET AWAY IN GROCERY STORE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21558102 ↗
• MalfunctionFeb 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF LENS MECHANICAL BREAKDOWN. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED AS PATIENT HAD NO IMPROVEMENT IN EYE AFTER INITIAL SURGERY .SURGEON STATED THAT THE INITIAL IOL WAS REMOVED AND REPLACED WITH BASIC IOL AND THE SYMPTOMS WERE RESOLVED AFTER THE EXPLANT. IN SURGEON OPINION MECHANICAL BREAKDOWN CONTRIBUTED TO POOR VISION.

  Patient problems: Visual Impairment

  MAUDE report 21405333 ↗
• InjuryJan 3, 2025Adverse 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 WITH BLURRY VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 1 MONTH 5 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS UNEXPECTED RESIDUAL MYOPIA/ASTIGMATISM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 21065975 ↗
• MalfunctionDec 30, 2024Break; Break

  A NURSE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SEEMED TO LOAD FINE HOWEVER THE SURGEON NOTICED THAT THE HAPTIC WAS OFF AND SEEMED LIKE A CLEAN BREAK, NOT CAUGHT OR TORN BY THE INTRODUCER AFTER IMPLANTING THE LENS. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER NEW LENS DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY FURTHER ADVERSE EVENTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21035480 ↗
• InjuryNov 28, 2024Defective Device; Defective Device

  A HEALTH CARE PROFESSIONAL REPORTED THAT, DEFECTIVE LENS THAT WAS IMPLANTED INTO A PATIENT ON (B)(6) HAD COMPLICATIONS AND IT HAD TO BE REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE PATIENT EXPERIENCED BLURRY VISION, HALOS AND GLARE. THERE WAS NO PATIENT HARM. THE LENS WAS REPLACED WITH COMPANY MONOFOCAL LENS.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 20805175 ↗
• MalfunctionJul 17, 2024Material Discolored; Material Discolored

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE NOTICED THAT FOGGY APPEARANCE OF INTRAOCULAR LENS WHEN IMPLANTED IN THE EYE, IT TAKES SEVERAL MINUTES FOR THE FOGGY APPEARANCE TO RESOLVE, DUE TO THAT SURGEON HAD DIFFICULTY CENTERING LENS. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO RIGHT EYE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19759207 ↗
• MalfunctionJul 15, 2024Material Discolored; Material Discolored

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, UPON INSERTION INTO EYE FOGGY APPEARANCE OF LENS WAS OBSERVED. TOOK SEVERAL MINUTES FOR THE FOGGY APPEARANCE TO RESOLVED BUT SURGEON FELT DIFFICULTY CENTERING LENS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE FILE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19742041 ↗
• InjuryFeb 23, 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, STATING HAVING BLURRY VISION ALL DISTANCES. PATIENT BEEN BACK TO THE SURGEON AND HE IS PERPLEXED AT THE OUTCOME AND DOES NOT HAVE ANY ANSWERS. PATIENT WAS A TARGET SHOOTER AND IS NOT ABLE TO SEE CLEARLY AT ANY DISTANCE TO DO THAT. PATIENT ALSO HAD A YTTRIUM ALUMINUM GARNET ( YAG ) LASER DONE IN HIS RIGHT EYE ONLY WITH NO IMPROVEMENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 18766642 ↗
• InjuryJun 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, PATIENT HAD POOR TOLERANCE. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS POOR BEST CORRECTED VISUAL ACUITY. ADDITIONAL INFORMATION RECEIVED STATED THAT PATIENT'S LEFT EYE WAS IMPACTED. WITH THE ORIGINAL IOL, THE PATIENT EXHIBITED LOW UNCORRECTED ACUITY AND GLARE AROUND BRIGHT LIGHTS. PATIENT'S SYMPTOMS WERE RESOLVED AFTER IOL EXCHANGE.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 17125258 ↗
• InjuryApr 3, 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 LENS WAS EXPLANTED AND REPLACED WITH OTHER LENS DUE TO WRONG POWER INTRAOCULAR LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 16665561 ↗
• MalfunctionMar 27, 2023Defective Component; Device Contamination with Chemical or Other Material; Defective Component; Device Contamination with Chemical or Other Material

  A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAPTIC WAS BROKEN AND FOUND DEBRIS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16618585 ↗
• InjuryFeb 10, 2023Material Opacification; Material Opacification

  ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND EXPLANT WAS SCHEDULED FOR ANOTHER EYE.

  Patient problems: Blurred Vision; Excessive Tear Production; Eye Pain; Irritability

  MAUDE report 16353765 ↗