Clareon CCWET6 (UDI 00380652456258)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652456258), received between Dec 20, 2023 and Jun 3, 2024 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 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, THE LENS DID NOT GIVE CLEAR DISTANCE VISION OR FUNCTIONAL READING VISON. THE LENS WAS A REPLACEMENT FOR CATARACTS, BUT DID NOT PERFORM NEARLY AS WELL AS THE SAME TYPE LENS IN OTHER EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE CORNEAL TRANSPLANT WAS DONE SIX MONTHS BEFORE THE CATARACT SURGERY. AFTER THE CATARACT SURGERY, PART OF THE CATARACT MEMBRANE STILL REMAINED, CAUSING INTERFERENCE WITH VISION. THREE MONTHS LATER, A LASER WAS USED TO REMOVE THAT MEMBRANE AND THE VISION WAS GREATLY IMPROVED. HOWEVER, THE VISION WAS NOT GREAT. DISTANCE VISION WAS NOT AS GOOD, WHICH WAS 20/30, WITH THE SAME TORIC LENS. THE PATIENT COULD READ WITH LEFT EYE, BUT NOT WITH RIGHT. HE COULD READ WITH BOTH EYES, WITH THE LEFT DOING ALL THE WORK. HIS OPHTHALMOLOGIST RECOMMENDED GETTING READING GLASSES, WHICH MADE READING EASIER. HE WAS NOT SATISFIED WITH THE RIGHT EYE RESULTS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 19448352 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT A LENS WAS PLACED IN CONSUMER'S LEFT EYE A YEAR AGO & MOST OF CONSUMER'S VISION HAD NOT BE GOOD SINCE. CONSUMER NEED 2 DIFF. PAIRS OF GLASSES NOW (NEAR & FAR) EVERY DAY. DOCTOR WAS ABRUPT AND CONSUMER'S WON'T RETURN TO HER AFTER SEVERAL VISITS. SHE GAVE CONSUMER A PAIR OF MINUS -.75 GLASSES "TO MAKE UP FOR IT"- HER WORDS. CONSUMER NEED +100 TO150 FOR READING, & MINUS -1.0 FOR DISTANCE & DRIVING. DISAPPOINTING & UPSETTING. CONSUMER WOULD APPRECIATE SOME ASSISTANCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE SURGEON GAVE ME A FREE PAIR OF GLASSES "TO MAKE UP FOR IT" WHEN WE DISCUSSED THE POOR VISION FOLLOWING THE SURGERY WITH IOL. CONSUMER THINKS THAT THE WRONG PRESCRIPTION WAS IMPLANTED. HE HAD TO WEAR TWO DIFFERENT PAIRS OF GLASSES TO REDUCE THE POWER FOR DISTANCE AND READING.

  Patient problems: Blurred Vision

  MAUDE report 18365397 ↗