Clareon CCWET0 (UDI 00380652405881)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652405881), received between Dec 23, 2022 and Aug 5, 2025 — classified as 2 injuries, 2 malfunctions.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2025Failure to Deliver; Failure to Deliver

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, RESISTANCE WAS NOTICED ON INSERTION. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT IN THE SURGEON'S OPINION, THE PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. THE PLAN WAS TO USE A DIFFERENT MODEL FROM THE SAME COMPANY CARTRIDGE ON 25.0 DIOPTER AND ABOVE MOVING FORWARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22716629 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAD HALOS. THE LENS WAS THEN EXCHANGED WITH A NON-COMPANY IOL AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON WAS MECHANICAL COMPLICATIONS OF IOL. ADDITIONAL INFORMATION RECEIVED STATING THAT PATIENT HAD BLURRED VISION. AS PER SURGEON'S OPINION PRODUCT CONTRIBUTED TO THE EVENT.

  Patient problems: Blurred Vision; Halo

  MAUDE report 20520663 ↗
• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND PATIENT EXPERIENCED LOW CONTRAST SENSITIVITY. DECOMPENSATED PHORIA WAS DIAGNOSED AFTER SURGERY AND REQUIRING PRISMS. CONVERGENCE INSUFFIENCY WAS ALSO DIAGNOSED IT HAS IMPROVED. PATIENT HAS DECIDED TO KEEP THE LENS AND NOT HAVE REMOVED. PATIENT HAS BEEN TO 27 DOCTORS SINCE HER SURGERY AND THE CURRENT SURGEON STATES SHE WAS ADAPTING TO LENS AND IMPROVING.

  Patient problems: Corneal Edema; Diplopia/Double Vision; Dry Eye(s); Eye Pain; Headache; Hypersensitivity/Allergic reaction; Visual Disturbances; Visual Impairment

  MAUDE report 18993890 ↗
• MalfunctionDec 23, 2022Defective Device; Defective Device

  NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS DAMAGED. BACK UP LENS WAS USED. THERE WAS PATIENT CONTACT, PROCEDURE WAS COMPLETED AND PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16041513 ↗