Clareon CCWTT0 (UDI 00380652413558)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652413558), received between Feb 12, 2025 and Sep 11, 2026 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  A non health care professional reported that following an intraocular lens (IOL) implant procedure, the patient experienced concentric rings/glare. Clinical reason being mentioned as other mechanical complication of IOL. The IOL was explanted and exchanged with an unspecified ATIOL (advanced technology intraocular lens) in the secondary implant procedure.Additional information has been requested and received stating that there was no patient harm.

  Patient problems: Visual Disturbances

  MAUDE report 50734228 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED, PATIENT LOST NEAR VISION BECAUSE HE WAS NO LONGER NEARSIGHTED. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, PATIENT OPTOMETRIST REFERRED HIM TO A RETINA SPECIALIST, WHO SAID HE HAD A MACULAR PUCKER, WHICH CAUSED THE VISION LOSS. HE SAID 15 PERCENT OF OLDER PEOPLE CAN GET THIS AND IT COULD STAY THE SAME OR GET WORSE OVER TIME. ALSO, EYE TRAUMA CAN CAUSE THIS OR LASER TREATMENT. RETINAL SPECIALIST SAID TREATMENT CAN BE JUST WAIT AND SEE IF IT GETS WORSE OR GO FOR SURGERY TO HAVE THE MEMBRANE THAT IS BUILDING UP OVER THE RETINA AND HAVE HIM DO A MEMBRANE PEEL. RETINAL SPECIALIST SAID HE PROBABLY WILL NEVER GET BACK TO 20/20 BUT WILL COME CLOSE. PATIENT OPTED FOR SURGERY ON OCTOBER 21, AND HIS VISION WAS MUCH BETTER BUT NOT 20/20. THE DOCTOR SAID IT CAN TAKE UP TO A YEAR TO SEE ALL OF THE IMPROVEMENT.

  Patient problems: Blurred Vision; Retinal Degeneration

  MAUDE report 23051766 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS DIFFICULTY WITH ADJUSTING TO LENS, LETTERS AND TEXT ARE DISTORTED, DIPPING AND ROLLING. SURGEON CONTINUED THE POST OPERATIVE DROPS LONGER AND SUSPECTS THERE MAY BE SWELLING. ADDITIONAL INFORMATION RECEIVED STATING THAT PATIENT'S ISSUE WAS RETINAL, SPECIFICALLY EPIRETINAL MEMBRANE.

  Patient problems: Inflammation; Visual Impairment

  MAUDE report 21960414 ↗
• InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, ON DAY ONE POST OPERATION, PATIENT NOTICED A GRADUAL IMPROVEMENT IN COLOR VISION AND EXPERIENCED SOME BLURRY VISION. ON ONE WEEK POST OPERATION PATIENT¿S VISION WAS STILL LITTLE BLURRY AND COLORS ARE MUCH BRIGHTER. IN FOLLOW UP VISIT PATIENT WAS DISSATISFIED WITH VISION. PATIENT COULD NOT SEE WELL AND IT WAS WORSE THAN BEFORE SURGERY. VISON WAS LIKE THIS ALL THE TIME. PATIENT COULD NOT READ ROAD SIGNS UNTIL RIGHT UP ON THEM. THE LENS WAS EXCHANGED WITH ANOTHER COMPANY LENS. AFTER LENS EXCHANGE THERE WAS IMPROVEMENT IN VISUAL ACUITY AND PATIENT WAS HAPPY WITH VISION AND DID NOT WANT GLASSES.

  Patient problems: Blurred Vision; Intraocular Pressure Increased

  MAUDE report 21363011 ↗