Clareon CCWTT0 (UDI 00380652413534)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00380652413534), received between Apr 28, 2023 and Sep 8, 2025 — classified as 12 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 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, THE PATIENT WAS EXPERIENCING HALOS. THE IOL WAS EXCHANGED FOR MONOFOCAL INTRA OCULAR LENS 4 MONTHS 4 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR THE EXPLANT IS DYSPHOTOPSIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 22993732 ↗
• MalfunctionAug 8, 2025Break; Failure to Deliver; Break; Failure to Deliver

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE IOL WAS LOCATED IN THE CENTER OF THE EYE WITH A CLEAR OPTIC AND NO CHANGE IN ORIENTATION. ONE HAPTIC WAS BROKEN AND REPLACED WITH ANOTHER LENS DURING THE INITIAL PROCEDURE. VITRECTOMY WAS NOT PERFORMED. THE PATIENT DID NOT NOTICE ANY DECREASE IN VISION. ACCORDING TO THE SURGEON, THE LENS WAS TIGHT WHILE INSERTING INTO THE EYE, AND THE SURGEON WAS NOT SURE OF THE REASON. THE CURRENT PATIENT PROGNOSIS WAS GOOD, AND THE ORIGINAL PROCEDURE WAS NOT COMPLICATED IN ANY WAY.

  Patient problems: Insufficient Information

  MAUDE report 22751197 ↗
• InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE PATIENT EXPERIENCED BLURRY DIM VISION AND ACHES CONSTANTLY. THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) AFTER THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON WAS OTHER MECHANICAL COMPLICATION OF IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Eye Pain

  MAUDE report 21752684 ↗
• InjuryJan 21, 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, THE PATIENT HAD THE MOST TROUBLE WITH DISTANCE AND NEAR VISION. NIGHT VISION TENDS TO BE WORSE. THE PATIENT IS USING CYCLOSPORINE TWICE A DAY AND USING PRESERVATIVE FREE ARTIFICIAL TEARS 1 TO 2 TIMES AN HOUR. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 21196290 ↗
• InjuryJan 20, 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, THE PATIENT EXPERIENCED WITH POOR VISION AND REFRACTIVE SURPRISE. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 03 MONTHS 27 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS MECHANICAL COMPLICATION DUE TO OCULAR PROTHESIS AND REFRACTIVE SURPRISE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 21190321 ↗
• InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLUR AT DISTANCE AND NEAR WITH GLARE AND HALOS. CLINICAL REASON BEING MENTIONED AS GLARE/HALOES/DYSPHOTOPSIA/BLUR ASSOCIATED WITH EDOF IOL (EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS). THE IOL WAS EXPLANTED AND EXCHANGED FOR AN NON COMPANY MONOFOCAL LENS FOLLOWING THE SECONDARY IMPLANT PROCEDURE. AS OF 1 WEEK OF POST OPERATION PATIENT SYMPTOMS RESOLVED AND THERE WAS NO IMPACT TO THE PATIENT. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO LEFT EYE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 20653724 ↗
• InjuryDec 29, 2023Adverse 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 SURGEON DECIDED TO EXPLANTED IOL IN SECONDARY PROCEDURE. THE REASON FOR EXPLANT WAS NOT MENTIONED. ADDITIONAL INFORMATION HAVE BEEN RECEIVED AND STATED THAT THE CLINICAL REASON FOR EXPLANT MENTIONED AS PATIENT WANTED CUSTOM DISTANCE VISION ONLY.

  Patient problems: Blurred Vision

  MAUDE report 18418159 ↗
• InjurySep 27, 2023Adverse 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 HAD CONSTANT MIGRAINES EVERYDAY. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS PATIENT UNABLE TO WORK DUE TO SYMPTOMS OF MIGRAINE AND NOT BEING ABLE TO READ FOR LONG PERIODS OF TIME. PATIENT HAS HAD TO LEAVE HER JOB DUE TO THE PHOTOPHOBIA AND HEADACHES SHE HAS BEEN HAVING. PATIENT IS ALSO HAVING DIZZINESS AND NAUSEA. PATIENT WAS TAKING OTHER COMPANY MEDICINE DAILY FOR MIGRAINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Dizziness; Headache; Nausea; Visual Disturbances

  MAUDE report 17823397 ↗
• InjurySep 8, 2023Adverse 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 PATIENT HAD VISION ISSUES LIKE SEE OUT OF THE EYE. THE CONSUMER THOUGHT WAS THAT, WRONG PRESCRIPTION LENS WERE IMPLANTED. THE SURGEON DID A STITCH TO HOLD THE LENS IN PLACE. IT MUST HAVE BEEN A LITTLE TIGHT THE ASTIGMATISM WAS A PLUS OR MINUS 6 AND PATIENT WAS ORIGINALLY A 3. AFTER REMOVAL OF STITCH, PATIENT COULD SEE INSTANTLY AFTER REMOVAL OF STITCH.

  Patient problems: Visual Impairment

  MAUDE report 17711854 ↗
• InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN OTHER HEALTH CARE PROFESSIONAL REPORTED ABOUT A LENS EXPLANTED IN A SECONDARY PROCEDURE APPROXIMATE 4 MONTHS AFTER THE INITIAL PROCEDURE DUE TO BLURRY VISION FOR COMPUTER. THE CLINICAL REASON WAS REPORTED AS MECHANICAL COMPLICATION. ADDITIONAL INFORMATION WAS RECEIVED STATING THE MAIN CONTRIBUTOR FOR EXPLANT WAS GLARE CAUSED BY IOL.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 17610467 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE DUE TO DECREASED VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 17553850 ↗
• InjuryAug 14, 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 WAS UNHAPPY WITH THE VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH A MONOFOCAL LENS. THE CLINICAL REASON FOR EXPLANT WAS DYSCHROMATOPSIA 'WAXY DISTANCE VISION'. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE PATIENT WAS NOT HOSPITALIZED BECAUSE OF THE EVENT AND THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 17541039 ↗
• MalfunctionMay 30, 2023Failure to Eject; Failure to Eject

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION WHILE PLACING LENS SURGEON WAS UNABLE TO GET THE CARTRIDGE INTO THE PATIENT EYE. THERE WAS PATIENT CONTACT AND PROCEDURE WAS COMPLETE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17024806 ↗
• InjuryApr 28, 2023Adverse 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 EXPERIENCED DYSPHOTOPSIA, VISION HALOS, DECREASED VISION AND BLURRY VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AFTER APPROXIMATELY POST THREE MONTH OF INITIAL IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances; Visual Impairment

  MAUDE report 16829065 ↗