Clareon CCWTT0 (UDI 00380652413565)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380652413565), received between Feb 27, 2023 and Oct 15, 2025 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Scratched 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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2025Adverse 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 HALOS AND POOR-QUALITY VISION. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN MONOFOCAL LENS IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 23299121 ↗
• InjuryJul 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 IN THE LEFT EYE, ON (B)(6) 2025 THE PATIENT EXPERIENCED BLURRY VISION AND EYE TWITCHING. ON (B)(6) 2025, THE PATIENT EXPERIENCED DYSPHOTOPSIA AND CONTINUED TO REPORT BLURRED VISION AND EYE TWITCHING. THE SURGEON STATED THE PRODUCT HAD CAUSED OR CONTRIBUTED TO THE EVENTS. REFRACTIVE MISS WAS RECALCULATED AFTER CONSULTING EXPERT OPINION WITH RECOMMENDATION TO EXCHANGE THE LENS AND PLACE A TORIC LENS FROM THE SAME COMPANY. CLINICAL REASON FOR EXPLANT WAS STATED AS DYSPHOTOPSIA. THE IOL WAS EXCHANGED FOR A TORIC MODEL FROM THE SAME COMPANY WITH A DIFFERENT DIOPTER LENS FOUR WEEKS FOLLOWING THE INITIAL IMPLANT PROCEDURE. IT WAS NOT REPORTED WHETHER THE PATIENT'S ISSUES WERE RESOLVED, BUT THERE WAS NO HARM TO THE PATIENT POST LENS EXCHANGE. ADDITIONAL INFORMATION WAS REQUESTED.

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

  MAUDE report 22556374 ↗
• InjuryMay 26, 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 HAD BLURRED VISION. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS PATIENT NEEDED LIMBAL RELAXING INCISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE IOL WAS EXCHANGED FOR ANOTHER COMPANY 0.5 DIOPTER LESS LENS. THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision; Eye Injury

  MAUDE report 22084434 ↗
• InjuryApr 2, 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 IOL WAS EXPLANTED WITH PATIENT REASON HALOS AT ALL TIMES, INDOORS AND OUTDOORS. THE LENS WAS EXPLANTED 3 MONTHS FOLLOWING THE INITIAL PROCEDURE AND EXCHANGED WITH MONOFOCAL IOL. CLINICAL REASON WAS MENTIONED AS VISUAL DISCOMFORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE 2 OF 2 FILES.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 21754348 ↗
• MalfunctionSep 27, 2024Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF SCRATCH ON INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20321766 ↗
• InjurySep 12, 2024Adverse 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 HAD MALADAPTATION. SO, THE LENS WAS REMOVED BY A SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20206211 ↗
• InjurySep 5, 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 5 MONTHS AND 13 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS MALADAPTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 20143292 ↗
• MalfunctionJun 26, 2024Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED WITH THE DESCRIPTION LARGE SCRATCH IN THE CENTER OF OPTIC. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE SURGEON WAS NOT SURE IF LENS HAD A DEFECT OR DAMAGED IN CARTRIDGE. THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND REPLACED WITH NEW LENS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19613480 ↗
• InjuryJun 20, 2024Adverse 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 EXPERIENCED POOR VISION QUALITY. CLINICAL REASON BEING UNABLE TO IMPROVE VISION TO BETTER THAN 20/30 WITH GLASSES. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 19573626 ↗
• InjuryFeb 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 EXPERIENCED -1.00 REFRACTIVE SURPRISE. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 12 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, AS PER THE SURGEON OPINION EFFECTIVE LENS POSITION (ELP) SURPRISE WOULD BE THE REASON FOR EXPLANT BUT NOT THE IOL. THERE WAS NO PATIENT HARM REPORTED. THE SYMPTOMS WERE RESOLVED.

  Patient problems: Visual Impairment

  MAUDE report 16442231 ↗