Clareon CCWET0 (UDI 00380652405782)Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00380652405782), received between Dec 6, 2022 and Sep 13, 2026 — classified as 26 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (4 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjurySep 13, 2026No Apparent Adverse Event

  Patient problems: Blurred Vision

  MAUDE report 50747104 ↗
• MalfunctionApr 20, 2026Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS IMPLANT PROCEDURE THE HAPTIC FOUND TO BENT. THE ORIGINALLY SCHEDULED PROCEDURE WAS COMPLETED ON THE SAME DAY. THE ISSUE OCCURRED DURING THE LOADING AND THERE WAS NO PATIENT CONTACT. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24924098 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION/ GLARE/ HALOS, LENS JUST DOES NOT WORK FOR PATIENT. LIKE THERE WAS A FINGERPRINT ON THE LENS, DIFFICULTY READING, SEEING STREET SIGNS. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 03 YEARS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THERE WAS NO FURTHER CONSEQUENCES TO THE PATIENT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24899964 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  A NONHEALTH CARE PROFESSIONAL REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE PATIENT WAS UNABLE TO FOCUS. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER UNSPECIFIED LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS INTOLERANCE.

  Patient problems: Blurred Vision

  MAUDE report 24579675 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER COMPANY¿S MONOFOCAL LENS DURING A SECONDARY PROCEDURE DUE TO A REPORTED MECHANICAL MALFUNCTION. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATIENT EXPERIENCED DEPTH-PERCEPTION ISSUES AND SIGNIFICANT NEAR-VISION BLURRINESS FOLLOWING THE INITIAL SURGERY. THE PATIENT LATER CONFIRMED THAT THESE VISUAL DISTURBANCES HAVE RESOLVED, AND NO FURTHER HARM HAS BEEN REPORTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 24483343 ↗
• InjuryOct 15, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO PATIENT EXPERIENCED REFRACTIVE SURPRISE. THE CLINICAL REASON FOR EXPLANT WAS REPORTED TO BE PATIENT HAD LASIK (LASER-ASSISTED IN SITU KERATOMILEUSIS) AND WRONG POWER LENS. THE IOL WAS REPLACED WITH UNSPECIFIED LENS ONE MONTH 28 DAYS AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 23280277 ↗
• InjurySep 8, 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, HIS VISION WAS NOT AS EXPECTED. HIS VISION WAS HAZY, FOGGY, AND BLURRY. HE VISITED HIS SURGEON MULTIPLE TIMES, BUT THE SURGEON COULD NOT PROVIDE A CLEAR REASON FOR THE LACK OF IMPROVEMENT, EXCEPT SUGGESTING THAT HE MIGHT HAVE DRY EYE. HE WAS REFERRED TO A DRY EYE SPECIALIST WHO PERFORMED PUNCTAL OCCLUSION USING LASER TREATMENT, WHICH WAS VERY PAINFUL AND DID NOT HELP. HE CONTINUED TO GO BACK AND FORTH BETWEEN THE TWO DOCTORS UNTIL HE FINALLY SOUGHT A SECOND OPINION FROM AN OPTOMETRIST. THE OPTOMETRIST PRESCRIBED EYE DROPS, WHICH IMPROVED THE COMFORT OF HIS EYES, AND SUSPECTED THAT THE ISSUE WAS WITH REFRACTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Dry Eye(s); Visual Impairment

  MAUDE report 22993727 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision; Diplopia/Double Vision; Visual Disturbances

  MAUDE report 22936911 ↗
• MalfunctionJun 20, 2025Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS SCRATCHED. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE SCRATCH WAS NOTICED AFTER IMPLANTATION HENCE THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS DURING THE SAME PROCEDURE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22299149 ↗
• InjuryJun 18, 2025Product Quality Problem; Scratched Material; Product Quality Problem; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT AND CLINICAL REASON FOR EXPLANT WAS MENTIONED AS DEFECTIVE LENS. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 14 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Diplopia/Double Vision; Insufficient Information

  MAUDE report 22284060 ↗
• InjuryJun 13, 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, IOL WAS EXPLANTED AS PATIENT NEEDED COMPANY LENS IN BOTH EYES DUE TO RIGHT EYE BEING DOMINANT AND UNABLE TO NEURO ADAPT. THE IOL WAS REPLACED WITH ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL). THE PATIENT ELECTED COMPANY MODEL LENS FOR HER 2ND EYE AFTER EXPERIENCING HALOES WITH ANOTHER COMPANY MODEL LENS IN HER FIRST EYE. MANY OF THEIR PATIENTS DID WELL WITH THIS COMBINATION. HOWEVER, AS A KINDERGARTEN TEACHER, SHE FOUND THAT SHE NEEDS MORE STEREO NEAR VISION THAN THIS COMBINATION PROVIDES. SHE EXPERIENCED ANISOMETROPIA AT NEAR AND REQUESTED SAME COMPANY MODEL LENS IN BOTH EYES AS AN EXCHANGE. IN RETROSPECT AFTER EXPERIENCING ONE OF THE COMPANY LENSES SHE WOULD RATHER HAVE THE NEAR VISION IN BOTH EYE AND DEAL WITH THE GLARE OR HALOES. THERE WAS NO PATIENT HARM.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 22202096 ↗
• InjuryFeb 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WAS SEEING RAYS AROUND LIGHTS AT NIGHT AND HALOS. PATIENT HAD BEEN SET UP FOR MODIFIED MONOVISION, WITH ONE EYE OPTIMIZED FOR DISTANCE AND THE OTHER FOR NEAR VISION. ALSO STATED DAYTIME VISION WAS SATISFACTORY. PATIENT HAD UNDERGONE A YAG (YTTRIUM ALUMINUM GARNET) LASER CAPSULOTOMY. PATIENT SYMPTOMS WERE CONTINUING. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 21457708 ↗
• MalfunctionFeb 25, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DEFECTIVE AND CRACKED. THE CRACK WAS IN CENTER OF THE OPTIC. THE LENS WAS IMPLANTED & EXPLANTED. THE LENS WAS KEPT WARM, LOADED WITH THE COMPANY FORCEPS AND ONLY FOLDED IN CARTRIDGE FOR DELIVERY THEN LOADED IMMEDIATELY BEFORE HANDING USING ROOM TEMP NON-COMPANY VISCOELASTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 2.

  Patient problems: Insufficient Information

  MAUDE report 21457456 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE LENS WAS REPLACED WITH NON COMPANY MONOFOCAL LENS.

  Patient problems: Blurred Vision

  MAUDE report 21033863 ↗
• InjuryNov 8, 2024Defective Device; Defective Device

  ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT PATIENT WITH PAIN AFTER SURGERY, IOP 52. NEED FOR VITRECTOMY FROM CATARACT SURGERY. NO PATIENT HARM WAS REPORTED.

  Patient problems: Blurred Vision; Eye Pain; Intraocular Pressure Increased

  MAUDE report 20641722 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT PERIPHERAL VISUAL ACUITY IS SEMI OBSTRUCTED. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS MODEL 2 MONTHS AND 16 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MYOPIC SURPRISE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 20558647 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HE CANNOT READ PRINT WITHOUT READING GLASSES. HE HAS SPOKEN WITH DOCTOR REGARDING THIS, SHE PRESCRIBED READING GLASSES. HE WOULD LIKE COMPANY TO REACH OUT TO THE SURGEON FOR FURTHER INFORMATION OF HIS OUTCOME. ADDITIONAL INFORMATION RECEIVED; THE CAUSE OF EVENT WAS LIMITATION OF EXTENDED DEPTH OF FOCUS TECHNOLOGY. THERE WAS NO PATIENT HARM. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 20557137 ↗
• MalfunctionOct 23, 2024Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A SCRATCH ON THE LENS. ADDITIONAL INFORMATION RECEIVED STATING THAT, THE LENS HAD A SCRATCH. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH ANOTHER LENS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20516755 ↗
• InjurySep 24, 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 WAXY VISION. CLINICAL REASON FOR EXPLANT WAS BEST CORRECTED VISION 20/20. THE IOL WAS EXCHANGED FOR MONOFOCAL NONCOMPANY LENS 01 MONTH 26 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 20291169 ↗
• InjuryJul 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 DISTANCE AND NEAR VISION WAS NOT GOOD. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS HYPEROPIC RESULT POST OP. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 19760406 ↗
• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED THAT PATIENT OPTED SECOND OPINION AND DOESN'T WANT TO PROCEED WITH ANY LASIK OR WITH IOL EXCHANGE. SHE WANTS TO KEEP LENSES AND EVENTUALLY ADAPT TO LENSES.

  Patient problems: Blurred Vision; Photophobia; Posterior Capsule Opacification; Visual Disturbances; Visual Impairment

  MAUDE report 19457336 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED THAT PATIENT OPTED SECOND OPINION AND DOESN'T WANT TO PROCEED WITH ANY LASIK OR WITH IOL EXCHANGE. SHE WANTS TO KEEP LENSES AND EVENTUALLY ADAPT TO LENSES.

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

  MAUDE report 19446347 ↗
• InjuryMay 13, 2024Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO PATIENT EXPERIENCED CONSTANT GLARE AND A STREAK IN VISION. THE CLINICAL REASON WAS REPORTED TO BE CREASE LINE TEMPORALLY, POSSIBLE SCRATCH SUPERIOR TEMPORAL ASPECT OF THE LENS. THE IOL WAS REPLACED WITH SAME COMPANY DIFFERENT DIOPTER LENS APPROXIMATELY TWO MONTHS AFTER INITIAL PROCEDURE.

  Patient problems: Visual Disturbances

  MAUDE report 19296484 ↗
• InjuryApr 29, 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 PERSISTENT DYSPHOTOPSIAS. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 04 MONTHS 27 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 19200230 ↗
• InjuryApr 25, 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 BLURRY VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 15 MONTHS 19 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS COMPLICATION OF IMPLANTED IOL. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND PATIENT HAD UNDERGONE YTTRIUM ALUMINUM GARNET (YAG) LASER SURGERY AND THERE WAS NO PATIENT HARM. IN THE SURGEON¿S OPINION PATIENT BRAIN UNABLE TO TOLERATE EXTENDED DEPTH OF FOCUS EFFECT.

  Patient problems: Blurred Vision

  MAUDE report 19179935 ↗