Clareon CCWET0 (UDI 00380652405737)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00380652405737), received between May 13, 2022 and May 8, 2026 — classified as 15 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem

  A NONHEALTH CARE PROFESSIONAL REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE PATIENT EXPERIENCED BLURRY DISTANCE AND READING. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS OTHER MECHANICAL COMPLICATIONS OF LENS.

  Patient problems: Blurred Vision

  MAUDE report 25122603 ↗
• InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem

  A NONHEALTH CARE PROFESSIONAL REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE PATIENT WAS DISSATISFIED WITH THE OUTCOME. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS DYSPHOTOPSIA. THE PHYSICIAN WAS UNCLEAR WITH THE ETIOLOGY OF BLURRED VISUAL ACUITY, FELT THE VISUAL ACUITY WAS BETTER WITH NEAR AND INTERMEDIATE VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Visual Disturbances

  MAUDE report 24843671 ↗
• MalfunctionJan 30, 2026Failure to Deliver

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS STUCK IN CARTRIDGE WITH PATIENT CONTACT ADDITIONAL INFORMATION WAS RECEIVED THAT IN THE SURGEON¿S OPINION IT WAS NOT RELATED TO THE PRODUCT, LENS WAS STUCK IN THE CARTRIDGE WHEN THE ADVANCING MECHANISM PUSHED OVER THE TOP OF THE LENS.

  Patient problems: Insufficient Information

  MAUDE report 24222364 ↗
• InjurySep 11, 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) IMPLANTATION PROCEDURE, THE PATIENT¿S INTERMEDIATE VISION WITH THE VIVITY LENS WAS NOT SATISFACTORY. THE LENS WAS EXPLANTED AND REPLACED WITH A MONOFOCAL LENS DURING A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS PERSISTENTLY POOR SUBJECTIVE DISTANCE VISION, EVEN WITH SPECTACLE CORRECTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 23026619 ↗
• MalfunctionJul 4, 2025Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED LENS WAS SCRATCHED AFTER THE IOL WAS IMPLANTED INTO THE EYE. THE LENS WERE INSERTED AND REMOVED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22403298 ↗
• InjuryMar 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, SINCE 2 DAYS POST-OP THE PATIENT HAD NEGATIVE DYSPHOTOPSIA IN LEFT EYE AND NO INTERMEDIATE VISION. AS A LIFELONG CONTACT LENS WEARER NOT HAVING TO WEAR GLASSES FOR INTERMEDIATE VISION WAS A TOP PRIORITY. PATIENT HAD GOOD DISTANCE VISION BUT HAD TO PUT ONE PAIR OF GLASSES TO SEE THE COMPUTER, ANOTHER PAIR OF GLASSES TO READ. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT SYMPTOMS HAD IMPROVED SLIGHTLY SINCE YAG (YTTRIUM-ALUMINUM-GARNET) LASER WAS PERFORMED. OPHTHALMOLOGIST SUGGESTED "REVERSE OPTIC CAPTURE" PROCEDURE FOR THE DYSPHOTOPSIA PATIENT EXPERIENCED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21700649 ↗
• InjuryMar 18, 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 WITH POOR VISUAL ACUITY AND FLICKERING. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 04 MONTHS 23 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS MALADAPTATION TO LENS. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, 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; Visual Disturbances; Visual Impairment

  MAUDE report 21633515 ↗
• InjuryMar 14, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD AN UNKNOWN ISSUE. THE IOL WAS EXCHANGED FOR SAME MODEL DIFFERENT DIOPTER TORIC COMPANY LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21606667 ↗
• InjuryDec 30, 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 IMPLANTATION SURGERY, THE PATIENT EXPERIENCED BLURRED VISION. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS BLURRED VISION. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision

  MAUDE report 21036400 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT AFTER SURGERY, THE PATIENT EXPERIENCED VISION IS BLURRY AT A DISTANCE, STRUGGLING DRIVING. CLINICAL REASON AIMED FOR PLANO, MR (REFRACTION) CAME OUT AT 02.50. SO, THEY HAVE PLANNED EXPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 20748252 ↗
• InjuryNov 8, 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 FELT THAT VISION WAS WORST WHEN LOOKING AT DISTANCE. THERE WAS MYOPIC SURPRISE DUE TO PRIOR LASIK. THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) APPROXIMATELY 2 MONTH AFTER THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 20641913 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED HAZY DISTANCE VISION. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS MECHANICAL DEFECT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision

  MAUDE report 19229308 ↗
• InjuryApr 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A CONSUMER REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, HE EXPERIENCED BLURRED VISION MOSTLY AT DISTANCE AND NEAR. THE LENS WAS REPOSITIONED DUE TO LENS BEING OUT OF PLACE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 19013056 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT AFTER AN INTRAOCULAR LENS(IOL) IMPLANTATION SURGERY, HER INTERMEDIATE VISION WAS BAD AND SHE WAS BACK TO GLASSES. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED FROM THE CONSUMER STATING AT DAY 1 POST OPETATIVE CHECK UP, DISTANCE VISION HAD IMPROVED (20/25), BUT HER READING AND INTERMEDIATE VISION WERE WORSE THAN BEFORE THE SURGERY. SHE COULD NOT EVEN READ ANYTHING ON THE LITTLE CARD THAT THEY TESTED HER READING VISION WITH. ON NEXT VISIT WHEN SHE WAS PREPARED FOR HER SECOND SURGERY, READING INTERMEDIATE VISION WAS NOT BETTER. HER PLATE WAS BLURRY, SHE WAS NOT ABLE TO SEE HER ALARM CLOCK ON HER SIDE OF THE BED, TROUBLE SEEING THE CLASP WHEN PUTTING ON JEWELRY, USING EYE MAKEUP AND SHE CAN'T READ ANYTHING WITHOUT HER GLASSES. AFTER SURGERY ON THE OTHER EYE, THE ISSUES STILL REMAINED. THE PATIENT WAS VERY DISAPPOINTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision

  MAUDE report 18978163 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT AFTER AN INTRAOCULAR LENS(IOL) IMPLANTATION SURGERY, HER INTERMEDIATE VISION WAS BAD AND SHE WAS BACK TO GLASSES. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED FROM THE CONSUMER STATING AT DAY 1 POST OPERATIVE CHECK UP, DISTANCE VISION HAD IMPROVED (20/25), BUT HER READING AND INTERMEDIATE VISION WERE WORSE THAN BEFORE THE SURGERY. SHE COULD NOT EVEN READ ANYTHING ON THE LITTLE CARD THAT THEY TESTED HER READING VISION WITH. ON NEXT VISIT WHEN SHE WAS PREPARED FOR HER SECOND SURGERY, READING INTERMEDIATE VISION WAS NOT BETTER. HER PLATE WAS BLURRY, SHE WAS NOT ABLE TO SEE HER ALARM CLOCK ON HER SIDE OF THE BED, TROUBLE SEEING THE CLASP WHEN PUTTING ON JEWELRY, USING EYE MAKEUP AND SHE CAN'T READ ANYTHING WITHOUT HER GLASSES. AFTER SURGERY ON THE OTHER EYE, THE ISSUES STILL REMAINED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 18969000 ↗
• InjuryJun 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MATERIALS MANAGER REPORTED THAT AFTER INTRAOCULAR LENS IMPLANTATION PROCEDURE, THE PATIENT ENDED UP BEING TOO NEAR SIGHTED. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 17070021 ↗
• InjuryApr 25, 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 LENS INTOLERANCE. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. PER SURGEON, PATIENT VISION WAS VERY BLURRED, GLARE AND FLOATERS. ADDITIONAL INFORMATION WAS RECEIVED STATING PATIENT UNDERWENT LIMBAL RELAXING INCISIONS (LRI). PATIENT'S ISSUES WERE RESOLVED BUT STILL HAS FLOATERS. THERE WAS NO PATIENT HARM AND PATIENT WAS NOT HOSPITALIZED AS A RESULT OF THIS EVENT.

  Patient problems: Blurred Vision; Visual Disturbances; Vitreous Floaters

  MAUDE report 16808109 ↗
• MalfunctionMay 13, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, NURSE FOUND THAT, LENS HAD SOMETHING ON IT (UNSPECIFIED). ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT THERE WAS NO PATIENT HARM, PATIENT WAS NOT HOSPITALIZED. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14401076 ↗