Clareon CCWET3 (UDI 00380652455336)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652455336), received between Apr 12, 2024 and Jun 2, 2026 — classified as 4 injuries, 4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Device Damaged by Another Device

  A PHYSICIAN REPORTED THAT DURING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, A SCRATCH WAS OBSERVED ON THE POSTERIOR SIDE OF THE LENS AFTER IT WAS IMPLANTED. THE LENS WAS INSERTED AND NOT REMOVED, AND IT WAS LEFT IMPLANTED. THE PROCEDURE WAS COMPLETED THE SAME DAY. SOMETHING PHYSICALLY SCRATCHED THE POSTERIOR SIDE OF THE IOL. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25360432 ↗
• MalfunctionApr 8, 2026Break

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS BROKEN. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, IN THE SURGEON OPINION IT COULD HAVE BEEN PRESSURE FROM THE PLUNGER. THE LENS WAS REMOVED FROM THE PATIENT EYE AND A BACKUP LENS OF SAME MODEL AND DIOPTER WAS IMPLANTED AND COMPLETED THE PROCEDURE ON THE SAME DAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24813655 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD BLURRY VISUAL ACUITY. THE IOL WAS EXCHANGED FOR UNSPECIFIED ADVANCED TECHNOLOGY INTRAOCULAR LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS PSEUDOPHAKIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.

  Patient problems: Blurred Vision

  MAUDE report 24303994 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY DISTANCE VISION. THE CLINICAL REASON FOR EXPLANT WAS DIFFICULTY ADAPTING TO THE EXTENDED DEPTH OF FOCUS (EDOF) TECHNOLOGY. THE IOL WAS EXCHANGED FOR A NON-COMPANY LENS WITH THE SAME DIOPTER 03 MONTHS 12 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. THERE WAS NO FURTHER IMPACT TO THE PATIENT. IN THE SURGEON'S OPINION, THE PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 24147063 ↗
• InjuryNov 7, 2024Defective Device; Defective Device

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR DISTANCE VISION. THE LENS WAS DEFECTIVE, AND AN EXPLANT WAS PLANNED. THE CLINICAL REASON FOR THE EXPLANT WAS A MYOPIC SURPRISE WITH POOR QUALITY OF VISION, BOTH UNCORRECTED AND CORRECTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 20628252 ↗
• MalfunctionJul 29, 2024Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE SURGICAL TECHNICIAN INFORMED THAT THE WEEK BEFORE THE SURGEON AND SHE NOTICED THAT THE LENS QUALITY WAS NOT UP TO PAR. WHEN THE SURGEON EVALUATED THE LENS UNDER THE MICROSCOPE THEY FELT THE LENS LOOKED INDENTED OR LIKE CUT HAD BEEN MADE ON THE LENS. THEY DID NOT WANT TO REMOVE THE LENS SO THEY LEFT IT IN THE EYE.THE SURGEON ASPIRATED AND POLISHED THE LENS, BUT DID NOT NOTICE ANY IMMEDIATE IMPROVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19849670 ↗
• MalfunctionMay 14, 2024Material Deformation; Material Deformation

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED DEFECT IN THE CENTRAL PORTION OF THE IOL AFTER THE IMPLANTATION. SUBSEQUENTLY, IT WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH NEW IOL . ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE PATIENT DOES NOT HAVE ANY ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19310434 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT PATIENT EXPERIENCED FUZZY PERIPHERAL VISION SINCE HAVING CATARACT SURGERY IN LEFT EYE ON (B)(6) 2024. SHE CANNOT SEE AT A DISTANCE. SHE MEASURED HER VISION TO BE CLEAR AT 19-31". SHE CALLED TO ASK IF THIS WAS EXPECTED WITH THE LENS. HER SURGEON SAID HER VISION SHOULD IMPROVE. SHE HAD THE FELLOW EYE DONE (B)(6) 2024 AND SEES GREAT. SHE WISHES THE LEFT EYE SAW AS WELL AS THE RIGHT EYE. HER NEXT APPOINTMENT WITH HER SURGEON WAS (B)(6) 2024. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT PATIENT DID NOT UNDERSTAND MINI-MONOVISION AND TARGET WAS -0.50 SPHERE FOR MORE NEAR VISION WITH THE LEFT EYE. SHE ALSO HAD MILD DYSPHOTOPSIA. SHE ALSO HAD DRY EYE CONTRIBUTING TO HER VISION COMPLAINTS. SHE WAS DOING BETTER AFTER LENS PLACED IN RIGHT EYE WITH PLANO TARGET. PROGNOSIS WAS GREAT. ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER STATING THAT SHE WAS STILL ADAPTING TO THE LENS. HAD CATARACT SURGERY WITH A LENS PUT IN MY RIGHT EYE ON (B)(6) . CAN ONLY SEE WELL INSIDE WITH BOTH EYES. THE RIGHT LENS HAD NO CLEAR VISION AND NOT ENOUGH DISTANCE, AND AS DISCUSSED, THE LEFT EYE ONLY HAD CLOSE VISION WITH NO DISTANCE. THE PATIENT HAD AN APPOINTMEN

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

  MAUDE report 19096500 ↗