Clareon CCWET0 (UDI 00380652405799)Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00380652405799), received between Sep 8, 2022 and Jul 1, 2026 — classified as 19 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Crack” (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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED POOR VISION QUALITY AND WAS NOT HAPPY. SUBSEQUENTLY, THE LENS WAS REMOVED AND REPLACED WITH A MONOFOCAL IOL. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SURGEON STATED THE PATIENT HAD UNDERGONE PREVIOUS LASIK. IN THE SURGEON¿S OPINION, THE PATIENT¿S IRREGULAR CORNEA CONTRIBUTED TO THEIR POOR VISION WITH THE LENS. THE LENS WAS REPLACED WITH ANOTHER COMPANY LENS.

  Patient problems: Blurred Vision

  MAUDE report 25676658 ↗
• InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD BLURRY VISION AND GLARE. THE IOL WAS EXCHANGED FOR UNSPECIFIED ADVANCED TECHNOLOGY INTRAOCULAR LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS OTHER MECHANICAL COMPLICATION OF IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 25487295 ↗
• MalfunctionJan 9, 2026Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS IMPLANTED, AND SURGEON NOTICED SCRATCH ON IOL. LENS WAS CUT AND REPLACED DURING INITIAL PROCEDURE. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24021203 ↗
• InjuryNov 26, 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 POOR DISTANCE VISION. CLINICAL REASON BEING MENTIONED AS MYOPIC SURPRISE IN PATIENT WITH PRIOR LASIK (LASER-ASSISTED IN SITU KERATOMILEUSIS). THE IOL WAS EXPLANTED AND EXCHANGED WITH AN UNSPECIFIED ATIOL (ADVANCED TECHNOLOGY INTRAOCULAR LENS) IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 23656603 ↗
• InjuryJul 14, 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 EXPERIENCED BLURRED/ SOFT FUZZY SUBOPTIMAL VISION AND IT ONLY REFRACTS TO 20/40. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER NON COMPANY LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 22492969 ↗
• InjuryJun 3, 2025Product Quality Problem; Product Quality Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DECREASED VISION IN RIGHT EYE. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 07 MONTHS 11 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS DEFECTIVE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 22133321 ↗
• InjuryMay 14, 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 EXPERIENCED GLARE AND HALOS AS WELL AS MYOPIC RESULT AND CLINICAL REASON FOR EXPLANT BEING S/P LASIK -0.75 REFRACTION POST 1ST SURGERY. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE PATIENT CAME IN FOR 2 WEEK POST OP C/O DEBILITATING GLARE AND HALOS AT NIGHT, WAS UNABLE TO DRIVE. THE SURGEON BELIEVED THAT THE PATIENT WAS UNABLE TO GET USED TO MULTIFOCALITY OF IOL. THE PATIENT ISSUES HAD RESOLVED. LENS WAS EXCHANGED WITH A NON-COMPANY LENS.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 22017241 ↗
• InjuryMay 9, 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, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO PATIENT EXPERIENCED GLARE. THE CLINICAL REASON WAS REPORTED TO BE PATIENT DISSATISFACTION. THE IOL WAS REPLACED WITH OTHER COMPANY LENS APPROXIMATELY FIVE MONTHS AFTER INITIAL PROCEDURE. NON-COMPANY VISCOELASTIC WAS USED.

  Patient problems: Visual Disturbances

  MAUDE report 21992762 ↗
• InjuryApr 4, 2025Optical Decentration; Optical Decentration

  THE PHYSICIAN REPORTED THAT, FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION. CLINICAL REASON SLIGHT DECENTRATION AND POWER ADJUSTMENT. THE IOL WAS EXPLANTED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFO RECEIVED.

  Patient problems: Blurred Vision

  MAUDE report 21771947 ↗
• InjuryApr 2, 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 IOL WAS EXPLANTED. CLINICAL REASON FOR EXPLANTATION AS MENTIONED AS WRONG POWER. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE LENS WAS EXPLANTED ONE MONTH FOLLOWING THE INITIAL PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: Visual Impairment

  MAUDE report 21754352 ↗
• InjuryMar 4, 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 WAS INTOLERANT TO VISUAL OUTCOMES. THE IOL WAS EXPLANTED AND EXCHANGED WITH NON COMPANY LENS IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS RECEIVED AND IT STATES THAT THE PATIENT VISION WAS NOT GREAT FOR DISTANCE OR NEAR. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 21514799 ↗
• InjuryFeb 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,LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO PATIENT EXPERIENCED POOR QUALITY OF VISION. THE CLINICAL REASON WAS REPORTED TO BE PATIENT NOT SATISFIED WITH QUALITY OF EDOF (EXTENDED DEPTH OF FOCUS) LENS. THE IOL WAS REPLACED WITH MONOFOCAL LENS APPROXIMATELY TWO MONTHS AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 21421624 ↗
• InjuryDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED POSITIVE DYSPHOTOPSIA. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS UNABLE TO TOLERATE THE LENS.

  Patient problems: Visual Disturbances

  MAUDE report 21025481 ↗
• InjuryNov 15, 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 NEGATIVE DYSPHOTOPSIA, SHADOW IN THE VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 01 MONTH 19 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS NEGATIVE DYSPHOTOPSIA AND PATIENT WAS BOTHERED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 20692798 ↗
• MalfunctionAug 30, 2024Adverse 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, THE IOL WAS CRACKED NEAR WHERE HAPTIC JOINS THE LENS. THE LENS WAS TAKEN OUT OF THE EYE. THE PROCEDURE WAS COMPLETED AND THE IOL WAS THROWN AWAY.

  Patient problems: Insufficient Information

  MAUDE report 20107930 ↗
• MalfunctionAug 28, 2024Crack; Crack

  A FACILITY REPRESENTATIVE REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL WAS CRACKED NEAR WHERE THE HAPTIC JOINED THE LENS. THE LENS WAS TAKEN OUT OF THE EYE AND THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20083405 ↗
• MalfunctionMar 4, 2024Scratched Material; Scratched Material

  ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING NO PATIENT HARM.

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

  MAUDE report 18825825 ↗
• InjuryFeb 20, 2024Defective Device; Defective Device

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT THE LENS WAS DEFECTIVE. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18738952 ↗
• InjuryAug 11, 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 HALOS, VISION BAD UP CLOSE AND DISTANT. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS PATIENT SAW 20/25 AFTER CORRECTION WITHOUT CORRECTION 20/70, MYOPIC SURPRISE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Halo; Visual Impairment

  MAUDE report 17511296 ↗
• InjuryJul 5, 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 DVA, HALOS & GLARE DAY AND NIGHT, CLINICAL REASON BEING INTOLERABLE DYSHOPSIS THE INITIAL IMPLANT PROCEDURE. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN MONOFOCAL ATIOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 17254738 ↗
• MalfunctionApr 28, 2023Defective Device; Defective Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS OBSERVED THAT A CHUNK OF THE IOL WAS MISSING FROM THE EDGE OF THE OPTIC. THE HAPTICS WERE INTACT BUT IT A VISIBLE PIECE OF THE IOL WAS GONE. THE IOL WAS THEN REMOVED AND THE BACKUP WAS PLACED WITH NO FURTHER INTERVENTION REQUIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT THERE WAS NO PATIENT HARM AND THE SURGEON PROGNOSIS WAS GOOD, NO FURTHER COMPLICATION WAS ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16830492 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MATERIALS MANAGER REPORTED THAT AFTER IMPLANTATION OF INTRAOCULAR LENS (IOL), THE PATIENT EXPERIENCED LENS INDUCED SHADOW WHICH WAS BLOCKING SIDE VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH A MONOFOCAL LENS. THE CLINICAL REASON FOR EXPLANT WAS NEGATIVE DYSPHOTOPSIA.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 16762611 ↗
• InjuryFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE MANAGER REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRINESS AND IT WAS NOT CORRECTED WITH GLASSES. THE LENS WAS EXPLANTED AND REPLACED WITH TORIC MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS POOR VISION QUALITY. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 16361982 ↗
• InjuryFeb 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED AND STATED THAT VISION HAS NOT IMPROVED. THE PATIENT HAD A FILM OVER VISION WHICH CAME ON VERY QUICKLY ACCORDING TO HER SURGEON. WILL HAVE 2ND OPINION NEXT WEEK FOR RIGHT EYE. HAS NOT HAD SURGERY FOR LEFT EYE YET.

  Patient problems: Blurred Vision; Inflammation; Visual Disturbances

  MAUDE report 16359649 ↗
• MalfunctionNov 22, 2022Crack; Crack

  A NON HEALTH CARE PROFESSIONAL REPORTED LENS WAS CRACKED IN THE CARTRIDGE, WAS REMOVED AND A NEW LENS WAS USED TO INSERT, THE LENS WAS IN CONTACT WITH THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15842862 ↗