Clareon CCWET4 (UDI 00380652455763)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652455763), received between Jun 20, 2023 and Feb 16, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Malposition of 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS REFRACTIVE ERROR. CLINICAL REASON IS REFRACTIVE ERROR SECONDARY TO LASIK. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) 2 MONTHS 2 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE PATIENT EXPERIENCED DISTANCE VISION WAS NOT SHARP AND BLURRY POST ONE WEEK OPERATION. IN SURGEON OPINION THE PRODUCT DID NOT CONTRIBUTE TO THE EVENT AND THE ISSUE WAS CAUSED BY PREVIOUS REFRACTIVE SURGERY. IT WAS ALSO STATED THAT THE SYMPTOMS WAS RESOLVED AND THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 24344550 ↗
• InjuryJun 20, 2023Malposition of Device; Malposition of Device

  A PATIENT REPORTED THAT AFTER THE IMPLANTATION OF INTRAOCULAR LENS IN THE RIGHT EYE, THE PATIENT'S VISION WAS BLURRY AND THE LENS GOT ROTATED THE SURGEON THEN ADVISED TO DO LASIK SURGERY AND HENCE TWO LASIK SURGERIES WAS DONE FOR THE RIGHT EYE AND NOW THE PATIENT'S VISION IS CLEAR AND THE PATIENT CAN CLEARLY SEE FAR AWAY. HOWEVER, THE PATIENT STATED THAT, ON LOOKING INTO A PERSON THE PATIENT COULD SEE THE GLOWING BLUE, LIKE BLUE TINT IN THE VISION. THEREFORE THE SURGEON ADVISED THAT THE PATIENT MIGHT REQUIRE AN EXPLANT AND THE LENS CAN BE REPLACED WITH A MONOFOCAL LENS. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE PATIENT COULD NOT SEE FAR AND INTERMEDIATE DISTANCES. THE PATIENT WAS ABLE TO SEE CLEAR FAR AWAY, BUT DO GET LOTS OF CHROMATIC ABERRATIONS, ALSO NEAR VISION IS NOT SHARP, 20 INCHES FROM THE FACE, THE PATIENT WAS EXPERIENCING SHADOWS UNDER LETTERS, GHOSTING. ONE WEEK AFTER THE IMPLANTATION, THE PATIENT CONSULTED THE PHYSICIAN VIA PHONE AND HE SUGGESTED TO USE DROPS FOR NOW WHICH WILL MAKE PUPIL LARGER OR SMALLER TO CHECK IF THE PATIENT GETS THE SAME SYMPTOMS SO THAT THE PHYSICIAN WILL FOLLOW UP WITH THE PATIENT LATER. THE PATIENT WAS WILLING TO REMOVE THIS LENS AN

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 17162708 ↗