Clareon CCWTT5 (UDI 00380652458399)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652458399), received between Apr 12, 2023 and Jun 10, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2026Device Dislodged or Dislocated

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COMPLAINED OF A FILM OVER THE LEFT EYE (OS). THE CLINICAL REASON WAS MENTIONED AS IOL DISPLACEMENT. THE IOL WAS EXPLANTED AND EXCHANGED WITH A NON-COMPANY LENS DURING A SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 25452559 ↗
• InjuryFeb 13, 2025Adverse 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 IN THE LEFT EYE. THE PATIENT EXPERIENCED AWESOME VISION THE DAY AFTER THE SURGERY; HOWEVER, VISION CONTINUOUSLY WENT DOWNHILL AND FOUR WEEKS LATER FLOATERS AND FILM WERE DEVELOPED. A LASER PROCEDURE WAS PERFORMED WITH NO CHANGE IN VISION. A VITRECTOMY WAS ALSO PERFORMED BY A DIFFERENT SURGEON TO REMOVE FLUID, FLOATERS, AND FILM. AFTER THE VITRECTOMY, THE PATIENT REPORTED CLEARER IN THE LEFT EYE, BUT NO CHANGE IN VISION. THE PATIENT QUESTION WAS WHETHER THE CATARACT SURGEON MIGHT HAVE IMPLANTED THE WRONG PRESCRIPTION LENSES OR EVEN SWAPPED THE LENSES BETWEEN THE EYES. PATIENT CANNOT DRIVE AND BEING IN THE CAR AT NIGHT WAS INTOLERABLE DUE TO THE BRIGHTNESS. EVEN BRIGHTNESS DURING THE DAY WAS AN ISSUE ALONG WITH NEEDING GLASSES TO SEE. THE PATIENT WOULD END UP HAVING TO WEAR GLASSES FOR ALL VISION, NEAR AND FAR AND THE GLARE WAS INTOLERABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE PATIENT WAS CONCERNED ABOUT THE POOR VISION AFTER SURGERY. WHEN THE FLOATIES, BLACK DOTS AND FILM HAPPENED, PATIENT CONTACTED RIGHT AWAY AND MADE AN APPOINTMENT. SURGEON WAS GOING TO DO A LASER PROC

  Patient problems: Blurred Vision; Macular Edema; Visual Disturbances; Vitreous Floaters

  MAUDE report 21373678 ↗
• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, SHE WAS SEEING FLICKERING IN BOTH EYES. SHE EXPLAINED THAT WHEN SHE GOES INTO A STORE & TRIED TO READ A LABEL, SHE WAS SEEING THE FLICKERING ACROSS HER CENTRAL VISION. SHE ALSO EXPERIENCED GLARE, HALOS, BLURRY VISION AND HYPERMETROPIA. SHE HAD A HARD TIME READING SMALL PRINT IN THE GROCERY STORE DUE TO "FLICKERING". SHE STATED THAT SHE HAD TROUBLE MAKING OUT FACES IN THE RESTAURANT DUE TO THINGS BEING FOGGY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 16723152 ↗