Clareon CCWET0 (UDI 00380652405652)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652405652), received between Mar 3, 2023 and Jun 10, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Defective Device” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2026Optical Decentration

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION AND CLINICAL REASON FOR EXPLANT BEING SUBLUXATION OF LENS. THE IOL WAS EXPLANTED AND EXCHANGED FOR A NON COMPANY LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Blurred Vision

  MAUDE report 25452558 ↗
• InjuryDec 11, 2025Adverse 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, HE EXPERIENCED BLURRY VISION. HE WAS NOT HAPPY WITH THE VISION. HE COULD SEE STREET SIGNS SLIGHTLY AT ABOUT 20 FEET. CONSEQUENTLY, THE LENS WAS REMOVED AND REPLACED WITH A MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS THAT THE PATIENT HAD VERY DRY EYE AND WAS NOT TOLERATING THE IOL. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Dry Eye(s)

  MAUDE report 23777040 ↗
• InjuryMar 12, 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 POST OPERATION VISION NOT CRISP. CLINICAL REASON BEING MENTIONED AS PATIENT NEEDED A TORIC INITIAL IOL CHOSEN WAS NOT TORIC. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL (ADVANCED TECHNOLOGY INTRAOCULAR LENS) IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 21584415 ↗
• InjuryOct 11, 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, HE EXPERIENCED POSITIVE DYSPHOTOPSIA. HE ALSO EXPERIENCED FLICKERING LIGHT, SOMETIMES HE COULD SEE THE LENS WITH A BRIGHT SIDE LIGHT AND A DARK ROOM, WORSE INDOORS WITH SIDE LIGHT, NOT AS BAD OUTSIDE IF SUNNY AND PUPILS WERE DILATED. THE VISION WAS WORST INDOORS WITH AMBIENT LIGHT OR A ROOM WITH LOTS OF WINDOWS. CONSUMER ALSO HAD DRY EYES. HIS RIGHT EYE DEVELOPED A STYE ON THE TOP AND THE BOTTOM OF THE LID. THE TOP STYE WAS GONE, THE BOTTOM WAS STILL THERE. HE WAS NOT SURE IF THAT WAS RELATED. CONSUMER REPORTED THAT SINCE SURGERIES, IT FELT LIKE HE WAS WEARING HARD CONTACT LENSES THAT NEED TO BE TAKEN OUT FOR RELIEF. HE SQUINTED A LOT, WHICH FELT LIKE IT HELPED WITH THE FLICKERING. THE CONSUMER HAD DISCUSSED THESE CONCERNS WITH HIS EYE CARE PROVIDER, WHO ADVISED TO WAIT A YEAR/OR TAKE DROPS TO DILATE EYES. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Dry Eye(s); Eye Irritation; Unspecified Eye / Vision Problem; Visual Disturbances

  MAUDE report 20425490 ↗
• InjuryFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED ABOUT AN INTRAOCULAR LENS (IOL) EXPLANT. THE CLINICAL REASON WAS REPORTED TO BE PSEUDOPHAKIA. LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18805670 ↗
• InjuryMar 3, 2023Defective Device; Defective Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION WHICH WAS NOT CORRECTED BY GLASSES. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS MALFUNCTION OF IOL. ADDITIONAL INFORMATION WAS RECEIVED STATING PATIENT WAS NOT HOSPITALIZED AS A RESULT OF THIS EVENT. IN THE SURGEON¿S OPINION, PATIENT WAS UNHAPPY WITH QUALITY OF VISION WITH LENS AND WANTED MONOFOCAL IOL FOR DISTANCE VISION ONLY.

  Patient problems: Blurred Vision

  MAUDE report 16476275 ↗