Clareon CCWTT3 (UDI 00380652457460)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652457460), received between Jan 11, 2023 and Oct 22, 2025 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (2 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT REASON AS IOL CAME TOO STRONG AND CLINICAL REASON FOR EXPLANT BEING BLURRY VISION IOL CAME TOO STRONG. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 23356034 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT AFTER SURGERY, THE PATIENT WAS UNABLE TO DRIVE AT NIGHT 2 HALOS. CLINICAL REASON BEING MENTIONED AS UNABLE TO TOLERATE GLARE, HALOS, QUALITY OF VISION. THE IOL(INTRAOCULAR LENS) WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN MONOFOCAL LENS IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 21055681 ↗
• InjurySep 4, 2024Adverse 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, THE PATIENT HAD MALADAPTATION. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS MODEL 2 MONTHS AND 10 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS MALADAPTATION. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20134438 ↗
• InjurySep 21, 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 IMPLANTATION SURGERY, THE PATIENT EXPERIENCED BLURRY VISION. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS BLURRY VISION. ADDITIONAL INFORMATION RECEIVED AND REPORTED THAT THE IOL WAS EXCHANGED FORM (24.5) DIOPTER TO (21.5) DIOPTER LENS OF SAME MODEL INDICATING THE CORRECT LENS POWER WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL.

  Patient problems: Blurred Vision

  MAUDE report 17789947 ↗
• MalfunctionMar 28, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT ON THE LENS IT APPEARED TO BE A CRACK ON THE POSTERIOR SIDE OF A IOL. WHEN SURGEON EXAMINED FURTHER AND ALTHOUGH IT WAS A STRAIGHT LINE RESEMBLING A SCRATCH, HE COULD ACTUALLY PEEL BACK THE EDGE OF THE LINE. HE COULD NOT REMOVE WITH SUCTION FROM I/A (IRRIGATION AND ASPIRATION), AND IT TOOK HIM ABOUT 5 MINUTES TO PEEL IT. AFTER HE PEELED IT OFF THE BACK OF THE LENS, IT WAS EASILY SUCTIONED OUT BY I/A WITH NO DAMAGE VISIBLE IN ANY WAY ON THE OPTIC/IOL.

  Patient problems: Insufficient Information

  MAUDE report 16625936 ↗
• MalfunctionJan 11, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT ON THE LENS IT APPEARED TO BE A CRACK ON THE POSTERIOR SIDE OF A IOL. WHEN SURGEON EXAMINED FURTHER AND ALTHOUGH IT WAS A STRAIGHT LINE RESEMBLING A SCRATCH, HE COULD ACTUALLY PEEL BACK THE EDGE OF THE LINE. HE COULD NOT REMOVE WITH SUCTION FROM I/A (IRRIGATION AND ASPIRATION), AND IT TOOK HIM ABOUT 5 MINUTES TO PEEL IT. AFTER HE PEELED IT OFF THE BACK OF THE LENS, IT WAS EASILY SUCTIONED OUT BY I/A WITH NO DAMAGE VISIBLE IN ANY WAY ON THE OPTIC/IOL.

  Patient problems: Insufficient Information

  MAUDE report 16136049 ↗