Clareon CCWTT3 (UDI 00380652457392)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00380652457392), received between Dec 13, 2022 and Jun 9, 2026 — classified as 16 injuries, 1 malfunction.

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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2026Break

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING SURGERY, HAPTIC BROKE OFF AND IT WAS REMOVED. FOLLOWING THE SURGERY THE PATIENT EXPERIENCED PAIN. AS A RESULT, THE INTRAOCULAR LENS (IOL) WAS EXPLANTED AFTER 10 MONTHS AND 8 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Eye Pain

  MAUDE report 25442616 ↗
• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED MYOPIC SURPRISE. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS PATIENT WANTS MORE DISTANCE VISION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 24518756 ↗
• InjurySep 12, 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 HAVING GLARE AND HALOS. THE IOL WAS EXCHANGED FOR MONOFOCAL INTRA OCULAR LENS 7 MONTHS 1 WEEK 5 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON IS PATIENT EXPERIENCING DYSPHOTOPSIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 23037823 ↗
• InjuryAug 5, 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 IOL WAS EXCHANGED FOR UNSPECIFIED LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS MECHANICAL COMPLICATION OF IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22717635 ↗
• InjuryJun 16, 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 IOL INTOLERANCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 22210215 ↗
• InjuryMar 28, 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 DECLINE ON VISION INTERMEDIATE RANGE. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS MODEL 7 MONTHS AND 9 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS MECHANICAL COMPLICATIONS OF INTRAOCULAR LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE PATIENT ISSUES WERE RESOLVED. THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision

  MAUDE report 21717611 ↗
• InjuryMar 27, 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, PATIENT EXPERIENCED VISION IS NOT CLEAR, CAN'T DRIVE AT NIGHT DUE TO HALOS, DRY EYES , SCRATCHY, HEADACHE. THE PATIENT HAD YAG ( YTTRIUM ALUMINUM GARNET ). THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision; Dry Eye(s); Eye Irritation; Headache; Visual Disturbances

  MAUDE report 21710756 ↗
• InjuryNov 19, 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 VISION IS BLURRY. THE IOL WAS EXCHANGED FOR THE ANOTHER LENS MODEL 3 MONTHS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR THE EXPLANT WAS MENTIONED AS NO IMPROVEMENT IN PATIENT VISION. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision

  MAUDE report 20721528 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DISTORTION IN HIS VISION AND THE PATIENT VISION AFTER THE SURGERY IS WORSE THAN BEFORE THE SURGERY. THE PATIENT UNDERWENT YAG LASER CAPSULECTOMY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 20618439 ↗
• 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 VISION WAS WORSE AFTER SURGERY. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS DISCOMFORT WITH DISTANCE AND READING VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20135265 ↗
• MalfunctionAug 29, 2024Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SCRATCH ON THE LENS WAS NOTICED. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH ANOTHER LENS.

  Patient problems: Insufficient Information

  MAUDE report 20096177 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAD DEBILITATING GLARE AND HALOS. THE LENS WAS EXCHANGED FOR AN UNKNOWN MONOFOCAL INTRAOCULAR LENS 3 MONTHS AND 29 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. THIS REPORT IS ASSOCIATED WITH TWO COMPLAINTS. THIS FILE IS FOR LEFT EYE. ADDITIONAL INFORMATION RECEIVED STATING THAT THE LENS WAS EXCHANGED WITH A COMPANY'S MONOFOCAL LENS OF SAME DIOPTER.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 20084253 ↗
• InjuryMay 6, 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 POOR VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 13 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS REFRACTIVE ERROR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 19248642 ↗
• InjuryApr 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT CANNOT SEE TO DRIVE, SHE'S VERY BOTHERED BY HER INABILITY TO SEE CLEARLY. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS OD VISION IS AN "F". ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT FOLLOWING IOL IMPLANT PROCEDURE THE PATIENT EXPERIENCED BLURRY VISION AT ALL DISTANCES. NO PATIENT HARM WAS REPORTED.

  Patient problems: Blurred Vision; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19114196 ↗
• InjuryFeb 21, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DOUBLE VISION ESPECIALLY LOOKING AT LIGHTS, SUBLUXATION OF LENS, EXPLANTED IOL AND REPLACED WITH 215 MONOFOCAL LENS MODEL. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE PATIENT HAS DOUBLE OR TRIPLE VISION ESPECIALLY LOOKING AT LIGHTS. IN THE SURGEON¿S OPINION A QUALITY ISSUE WITH THE IOL CAUSE OR CONTRIBUTED TO THE EVENT AND SURGEON¿S PROGNOSIS WAS GOOD. THE PATIENT¿S ISSUES WERE RESOLVED.

  Patient problems: Diplopia/Double Vision

  MAUDE report 18745994 ↗
• InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED GLARE AND HALOS. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS VISUAL DISTURBANCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 17974190 ↗
• InjuryDec 13, 2022Adverse 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 DECREASED VISION. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 2 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 15967976 ↗