Clareon CCWET0 (UDI 00380652405775)Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00380652405775), received between Nov 19, 2022 and Sep 11, 2026 — classified as 28 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (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. 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 11, 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 glares and halos. The lens was exchanged for another lens model 09 months 06 days following the initial procedure. Clinical reason for explant was mentioned as other mechanical complication of IOL.Additional information was received and stated, the lens was exchanged with other company lens model. There was no patient harm.

  Patient problems: Visual Disturbances

  MAUDE report 50731613 ↗
• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT EXPERIENCED BLURRY VISION. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. CLINICAL REASON FOR THE EXPLANT WAS MYOPIC SURPRISE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 24924099 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD DYSPHOTOPSIA. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24744191 ↗
• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COULD NOT TOLERATE THE LENS. THE CLINICAL REASON WAS MENTIONED AS PATIENT DISCOMFORT. THE IOL WAS EXPLANTED AND EXCHANGED WITH AN UNSPECIFIED MONOFOCAL LENS. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT IT HAD BEEN AN UNCOMPLICATED CATARACT SURGERY, THE PATIENT WAS ONLY ABLE TO CORRECT TO 20/50. IN THE SURGEON¿S OPINION, PATIENT INTOLERANCE HAD CAUSED THE EVENT. THERE HAD BEEN NO FURTHER IMPACT TO THE PATIENT. THE IOL WAS EXCHANGED WITH NON-COMPANY LENS.

  Patient problems: Eye Irritation; Visual Impairment

  MAUDE report 23716510 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE PATIENT'S ISSUES RESOLVED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 23551857 ↗
• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION OR QUALITY DISTANCE. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 11 MONTHS 10 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS RESIDUAL MYOPIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 23061968 ↗
• InjurySep 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED BY STATING, LENS WAS EXPLANTED NON-COMPANY LENS.

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

  MAUDE report 22993754 ↗
• InjurySep 4, 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, THE PATIENT EXPERIENCED BLURRY VISION AT ALL DISTANCES. WHILE WORKING ON THE COMPUTER THE VISION WAS BLURRY. WHEN READING COULDN'T READ FOR VERY LONG AND EYES GETS TIRED. THE COLORS LOOK MORE VIVID, BUT NOTHING WAS DEFINED. THE PATIENT USES GEL AT NIGHT AND IN THE MORNING. THE LENS WAS EXPLANTED ONE MONTH FOLLOWING THE INITIAL PROCEDURE WITH NON-COMPANY LENS. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS PATIENT DISSATISFACTION. IN SURGEON OPINION THE IOL DID NOT CONTRIBUTE THE EVENT.

  Patient problems: Blurred Vision; Eye Pain

  MAUDE report 22965614 ↗
• InjurySep 2, 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 AN ISSUE WITH GLARE AND A STARBURST EFFECT IN THE EVENING WHILE OUTSIDE AND NEEDING TO USE BRIMONIDINE 0.2 PERCENT EYE DROPS TO REDUCE THE EFFECTS. THE GLARE IN EVENING LIGHTING CONDITIONS WAS CAUSING DISCOMFORT AND REDUCED VISION CLARITY WITH NIGHTTIME DRIVING OR WHILE IN ROOMS WITH HARSH FLUORESCENT LIGHTS IF THE EYEDROPS ARE NOT USED. ANOTHER ISSUE WAS THAT PATIENT VISION WAS DIFFERENT BETWEEN BOTH EYES. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 22933136 ↗
• InjurySep 2, 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 AN ISSUE WITH GLARE AND A STARBURST EFFECT IN THE EVENING WHILE OUTSIDE AND NEEDING TO USE BRIMONIDINE 0.2 PERCENT EYE DROPS TO REDUCE THE EFFECTS. THE GLARE IN EVENING LIGHTING CONDITIONS WAS CAUSING DISCOMFORT AND REDUCED VISION CLARITY WITH NIGHTTIME DRIVING OR WHILE IN ROOMS WITH HARSH FLUORESCENT LIGHTS IF THE EYEDROPS ARE NOT USED. ANOTHER ISSUE WAS THAT, PATIENT VISION WAS DIFFERENT BETWEEN BOTH EYES. 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: Visual Disturbances

  MAUDE report 22932568 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED AFTER INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS HAPPY WITH THE VISION IN THE FIRST POST-OP APPOINTMENT. HOWEVER, HE REPORTED THAT THE PRESCRIBED UNSPECIFIED MEDICATED EYE DROPS REALLY BURNED HIS EYES. TWO DAYS AFTER THE APPOINTMENT HE NOTICED CHANGE IN HIS VISION I.E, SOME DOUBLE VISION OR SHADOW VISION. NEXT WEEK IN SURGEON APPOINTMENT HE STATED THAT A FILM MIGHT BE DEVELOPING ON THE LENS. THE PATIENT COULD NOT TELL MUCH DIFFERENCE BETWEEN RIGHT OR LEFT EYE. THE PATIENT ALSO REITERATED THAT THE DROPS WERE REALLY BURNING HIS EYES. SURGEON GAVE HIM DROPS THAT DID NOT HAVE ONE OF THE MEDICATIONS IN THEM. THESE ALSO BURNED PATIENT EYES. SURGEON STATED THAT THE FILM COULD BE REMOVED LATER AND THAT SHOULD HELP CLEAR UP THE PROBLEM. 1 MONTH POST OP THE PATIENT STILL HAVE DOUBLE VISION & BLURRED VISION. SURGEON STATED WE CAN DO A CAPSULOTOMY TO TRY TO FIX THE PROBLEM. A CAPSULOTOMY WAS PERFORMED, AND IT DID NOT HELP. LASIK WAS SUGGESTED TO CORRECT IT AND SURGEON SUGGESTED TO WEAR GLASSES BUT UNFORTUNATELY, THEY ALSO DIDN¿T HELP. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT

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

  MAUDE report 22894371 ↗
• InjuryJul 17, 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, PATIENT HAD BLURRED VISION AND RESIDUAL REFRACTIVE ERROR. THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS RESIDUAL REFRACTIVE ERROR AND MECHANICAL COMPLICATIONS OF IOL.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 22538903 ↗
• InjuryApr 17, 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, THE PATIENT HAD HARD TIME HAVING EYES WORKING TOGETHER. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS MODEL 3 MONTHS AND 7 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS MYOPIC OUTCOME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 21858604 ↗
• InjuryApr 4, 2025Optical Decentration; Optical Decentration

  THE NON-HEALTHCARE PROFESSIONAL REPORTED THAT, FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION. CLINICAL REASON SLIGHT DECENTRATION AND NEURO ADAPTION FAILURE. THE IOL WAS PLANNED TO REPLACE WITH THE ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFO RECEIVED. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT IOL HAS BEEN REPLACED IN A SECONDARY PROCEDURE.

  Patient problems: Blurred Vision

  MAUDE report 21772857 ↗
• InjuryMar 10, 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, THE PATIENT EXPERIENCED POOR DISTANCE VISION. CLINICAL REASON FOR EXPLANT WAS MYOPIC OUTCOME DUE TO IN OFFICE CALCULATION. THE IOL WAS EXCHANGED FOR UNSPECIFIED ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) MODEL LENS 02 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 21561318 ↗
• InjuryMar 10, 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, THE PATIENT EXPERIENCED WITH BLURRY VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 01 MONTHS 15 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS CANNOT READ WITH LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 21557475 ↗
• InjuryDec 31, 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, GLARE, LIGHT SENSITIVITY AND SHADOWS. THE IOL WAS EXCHANGED FOR MONOFOCAL LENS MODEL 2 MONTHS AND 14 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS MECHANICAL COMPLICATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21045914 ↗
• MalfunctionOct 17, 2024Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF MULTIPLE SCRATCHES ON INTRAOCULAR LENS (IOL). UPON VISUALIZATION OF SCRATCHES AFTER IMPLANTATION THE SURGEON NEEDED TO REMOVE IOL AND IMPLANT BACKUP IOL. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20471735 ↗
• InjuryAug 14, 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 WAS VERY UNHAPPY WITH NEAR VISION. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS PATIENT FELT +1.5 WAS NOT STRONG ENOUGH. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 19979617 ↗
• InjuryJun 6, 2024Application Program Problem: Power Calculation Error; Application Program Problem: Power Calculation Error

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR DISTANCE VISION. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS MENTIONED AS WRONG POWER CHOSEN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 19474673 ↗
• InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT AFTER CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, SHE EXPERIENCED BLURRY VISION AND HALOS. HER SURGEON SUGGESTED THAT HE WILL EXPLANT AND REPLACE WITH A MONOFOCAL LENS. THE LENS WAS LATER REMOVED IN A SECONDARY PROCEDURE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances; Visual Impairment

  MAUDE report 19348901 ↗
• MalfunctionApr 25, 2024Scratched Material; Scratched Material

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS SCRATCHED. THE PROCEDURE COMPLETED WITH NEW LENS DURING INITIAL PROCEDURE. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19179734 ↗
• MalfunctionMar 14, 2024Failure to Advance; Failure to Advance

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, STATING LENS WOULD NOT ADVANCE, JAMMED IN CARTRIDGE. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18901766 ↗
• InjuryOct 17, 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 BLURRED VISION. THE IOL WAS EXCHANGED FOR ANOTHER LENS 1 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON MECHANICAL COMPLICATIONS WITH ANISOMETROPIA WITH RESIDUAL MYOPIA AND ASTIGMATISM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 17950210 ↗
• InjuryOct 17, 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 BLURRED VISION. THE IOL WAS EXCHANGED FOR ANOTHER LENS 1 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON MECHANICAL COMPLICATIONS WITH ANISOMETROPIA WITH RESIDUAL MYOPIA AND ASTIGMATISM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 17949900 ↗