Clareon CCWET3 (UDI 00380652455350)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380652455350), received between Jan 20, 2023 and Aug 11, 2026 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Crack” (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 16, 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.

• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  A non-healthcare professional reported that following the intraocular lens (IOL) implant procedure, patient experienced poor low light vision which made driving impossible at night. The vision in artificial light focus field limited to 10 yards and driving at night was impossible with no available mid or distance focus, huge glare off reflective signs and headlights. Additional information requested and received that patient discussed with the surgeon about symptoms and was said eye was healthy and the surgery appears to be flawless.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 50207882 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT REPORTED UNSPECIFIED ISSUE. THE IOL HAD BEEN EXPLANTED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24545398 ↗
• 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 THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT EXPERIENCED DECREASED VISION. THE IOL HAD BEEN EXCHANGED IN A SECONDARY PROCEDURE. CLINICAL REASON FOR THE EXPLANT IS REFRACTIVE SURPRISE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 23288128 ↗
• MalfunctionOct 15, 2025Dent in Material; Dent in Material

  A NURSE REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE SURGEON NOTICED THAT THE IOL WAS DEFECTIVE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT WHEN THE LENS WAS HALFWAY INSERTED INTO EYE WHEN THE DEFECTIVE EDGE OF LENS WAS NOTICED. THEY DID NOT INSERT COMPLETELY, IT WAS REMOVED AND REPLACED WITH SAME MODEL AND DIOPTER COMPANY LENS. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH NO PATIENT HARM. THE PATIENT IS RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23276955 ↗
• InjurySep 12, 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 EXPERIENCED REFRACTIVE SURPRISE, BLURRY VISION AND CLINICAL REASON FOR EXPLANT BEING SPHERICAL EQUIVALENT OF -1.00. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE LENS WAS CUT IN HALF AND DISCARDED. THE PATIENT JUST ENDED UP MYOPIC AND LENS WAS SWITCHED OUT.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 23041985 ↗
• InjuryAug 14, 2024Crack; Crack

  A CONSUMER WHO IS A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE LENS WAS CRACKED FOLLOWING PLACEMENT. LENS WAS BROKEN INTO PIECES DURING PROCESS TO REMOVE DEFECTIVE LENS. PATIENT WAS WAITING FOR APPOINTMENT TO DETERMINE THAT ALL DEFECTIVE LENS PIECES WERE REMOVED FROM EYE. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING SYMPTOMS IN THE RIGHT EYE WERE REPORTED AS REDUCED VISUAL ACUITY, EXCESS FLUID IN THE RIGHT EYE AND EXCESS FLOATERS. AN ULTRASOUND OF THE RIGHT EYE WAS SCHEDULED TO DETERMINE IF ALL THE PIECES OF THE BROKEN LENS HAVE BEEN REMOVED FROM THE RIGHT EYE. CURRENT PRESCRIPTION WAS NACL 5 PERCENTAGE EYE DROPS IN RIGHT EYE FOUR TIMES A DAY. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING IOL MATERIAL WOULD BREAK OFF, SURGEON HAD TO ENLARGE INCISION TO REMOVE MATERIAL NOT AS TOUGH AS OTHER MODEL OF COMPANY LENS. PROCEDURE WAS COMPLETED ON THE SAME DAY. SURGEON'S OPINION, POSSIBLY LENS MATERIAL MORE BRITTLE OR POSSIBLY COMPANY INJECTOR WAS RELATED. HARM WAS UNKNOWN AT THE TIME OF REPORTING, AND CORNEAL EDEMA WAS RESOLVING. PATIENT ISSUES WERE NOT RESOLVED. SURGEON'S PROGNOSIS WAS REPORTED AS LIKELY GOOD.

  Patient problems: Corneal Edema; Eye Injury; Visual Impairment; Vitreous Floaters

  MAUDE report 19983200 ↗
• InjuryJun 20, 2024Crack; Crack

  A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE LENS WAS CRACKED FOLLOWING PLACEMENT. LENS WAS BROKEN INTO PIECES DURING PROCESS TO REMOVE DEFECTIVE LENS. PATIENT WAS WAITING FOR APPOINTMENT TO DETERMINE THAT ALL DEFECTIVE LENS PIECES WERE REMOVED FROM EYE. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING SYMPTOMS IN THE RIGHT EYE WERE REPORTED AS REDUCED VISUAL ACUITY, EXCESS FLUID IN THE RIGHT EYE AND EXCESS FLOATERS. AN ULTRASOUND OF THE RIGHT EYE WAS SCHEDULED TO DETERMINE IF ALL THE PIECES OF THE BROKEN LENS HAVE BEEN REMOVED FROM THE RIGHT EYE. CURRENT PRESCRIPTION WAS NACL 5 PERCENTAGE EYE DROPS IN RIGHT EYE FOUR TIMES A DAY.

  Patient problems: Corneal Edema; Visual Impairment; Vitreous Floaters

  MAUDE report 19575843 ↗
• InjuryNov 23, 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 WAS UNHAPPY WITH VISION. THE PATIENT EXPERIENCED HALOS, MORE AT NIGHT, HALO GETS BIGGER THE FARTHER AWAY THE OBJECT (20-30+ FEET) AND ALSO EXPERIENCING NEGATIVE DYSPHOTOPSIA. THE SURGEON PRESCRIBED BRIMONIDINE TO TRY FOR NIGHT DRIVING 20 MINUTES BEFORE LEAVING THE HOUSE TO HELP WITH THE HALOS. BUT THE PATIENT DID NOT TRIED. THE PATIENT WAS UNABLE TO DRIVE AT NIGHT. THE DOCTOR SUGGESTED YAG LASER BUT WILL NOT DO IT UNTIL PATIENT DECISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 18198536 ↗
• MalfunctionApr 13, 2023Defective Device; Defective Device

  ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16730888 ↗
• InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS EXPLANTED. THE CLINICAL REASON FOR EXPLANTATION WAS KERATOCONUS THAT GAVE VISUAL ACUITY TO PATIENT. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOR NON-COMPANY LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT SURGEON PROGNOSIS WAS GLASSES AT DISTANCE AND NEAR AND A POTENTIAL RIGID GAS PERMEABLE LENS FOR BEST VISUAL ACUITY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 16214429 ↗