Clareon CCWTT0 (UDI 00380652413527)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652413527), received between Oct 4, 2023 and Sep 8, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Application Program Problem: Power Calculation Error” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 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 HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS BOTHERED BY HALOS. CLINICAL REASON BEING MENTIONED AS DYSPHOTOPSIA. THE IOL WAS EXPLANTED AND EXCHANGED WITH AN UNKNOWN LENS IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 22993733 ↗
• InjuryAug 13, 2025Adverse 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 STARBURST, GLARE AND HALOS AROUND LIGHT AND IT TAKES AN HOUR OR TWO IN THE MORNING FOR VISION TO COME INTO FOCUS FOR HIM TO READ OR DRIVE. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH NON COMPANY MONOFOCAL LENS IN A SECONDARY PROCEDURE AND THE PATIENT WAS DOING WELL. CLINICAL REASON FOR EXPLANT WAS DUE TO PATIENT'S LIFESTYLE WORK AND DRIVING AT NIGHT SO THE PATIENT CANNOT SUCCESSFULLY NEUROADAPT. THERE WAS NO FURTHER IMPACT TO THE PATIENT. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO LEFT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 22791693 ↗
• InjuryAug 12, 2025Adverse 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 STARBURST, GLARE AND HALOS AROUND LIGHT AND IT TAKES AN HOUR OR TWO IN THE MORNING FOR VISION TO COME INTO FOCUS FOR HIM TO READ OR DRIVE. THE GLARE, HALOS, AND STARBURSTS WAS A PROBLEM FOR THE PATIENT TO DRIVE AT NIGHT. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO RIGHT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 22783800 ↗
• InjuryMay 1, 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, EXPLANTED LENS WITH PATIENT REASON AND CLINICAL REASON WAS NOT TOLERATING LENS. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) 1 YEAR 2 MONTHS AND 28 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE.

  Patient problems: Visual Impairment

  MAUDE report 21942173 ↗
• InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT AFTER SURGERY THAT THE PATIENT EXPERIENCED HAZE FROM DAY 1, SO THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND KEPT IN A STERILE CUP WITH STERILE SALINE THEN WANTS TO CHECK FOR THE DEFECT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 21272964 ↗
• InjuryApr 16, 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 EXPERIENCED WITH FOGGY VISION, HARD SEEING AT ALL RANGES. THE LENS WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS MODEL 4 MONTHS 26 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS FAILURE TO ADAPT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT PATIENT ISSUES RESOLVED WITH IOL EXCHANGE AND SURGEON PROGNOSIS WAS GOOD. NO PATIENT HARM WAS REPORTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 19116775 ↗
• InjuryOct 19, 2023Application Program Problem: Power Calculation Error; Application Program Problem: Power Calculation Error

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION . THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 2 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANT MENTIONED AS WRONG POWER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 17965789 ↗
• InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED A MONTH AFTER IMPLANTATION DUE TO PATIENT SEEING DOUBLE VISION AND BLURRY VISION. THE LENS WAS REPLACED WITH A NON COMPANY LENS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE PATIENT SEE SHADOWS BEHIND LETTERS (WHEN READING TEXT). THE PATIENT'S SYMPTOMS WERE RESOLVED POST IOL REPLACEMENT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 17866992 ↗