Clareon CCWET0 (UDI 00380652405768)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00380652405768), received between Sep 16, 2022 and Mar 9, 2026 — classified as 17 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (3 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO PATIENT EXPERIENCED BLURRY VISION, RESIDUAL MYOPIA. THE CLINICAL REASON FOR EXPLANT WAS REPORTED TO BE RESIDUAL MYOPIA. THE IOL WAS REPLACED WITH UNSPECIFIED LENS APPROXIMATELY ONE YEAR 2 MONTHS AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 24550465 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO PATIENT EXPERIENCED BLURRY VISION. THE CLINICAL REASON FOR EXPLANT WAS REPORTED TO BE RESIDUAL CYLINDER. THE IOL WAS REPLACED WITH UNSPECIFIED ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 24442855 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS HAVING POOR VISION. CLINICAL REASON IS MALADAPTION. THE IOL WAS EXCHANGED FOR NON COMPANY MONOFOCAL INTRA OCULAR LENS 5 MONTHS 2 WEEKS 1 DAY FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION RECIEVED AND STATED THAT PATIENT WAS COMPLAINING ALL OVER HAZE AND POOR NEAR VISION SINCE DAY 1 POST OPERATION. THERE WAS NO PATIENT HARM. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS ASSOCIATED TO LEFT EYE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 23957168 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT, THE IOL WAS EXCHANGED FOR THE DIFFERENT LENS MODEL AND DIOPTER INDICATING THE CORRECT LENS POWER WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 23815844 ↗
• InjuryOct 16, 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 BLURRED DISTANCE VISION. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ADVANCED TECHNOLOGY INTRAOCULAR LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS RESIDUAL REFRACTIVE ERROR ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 23310438 ↗
• MalfunctionOct 15, 2025Break; Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTICS BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 23298013 ↗
• InjurySep 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED, PATIENT EXPERIENCED CONSTANT PROBLEMS WITH DYSPHOTOPSIA. THE COMPANY LENS WAS EXCHANGED FOR A NON-COMPANY LENS.

  Patient problems: Visual Disturbances

  MAUDE report 22993756 ↗
• InjuryMar 18, 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 UNABLE TO SEE TV OR WORK ON COMPUTER AND TERRIBLE VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 02 MONTHS 09 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS MECHANICAL COMPLICATIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 21628481 ↗
• InjuryFeb 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WAS SEEING RAYS AROUND LIGHTS AT NIGHT AND HALOS .PATIENT HAD BEEN SET UP FOR MODIFIED MONOVISION, WITH ONE EYE OPTIMIZED FOR DISTANCE AND THE OTHER FOR NEAR VISION. ALSO STATED DAYTIME VISION WAS SATISFACTORY. PATIENT HAD UNDERGONE A YAG(YTTRIUM ALUMINUM GARNET) LASER CAPSULOTOMY. PATIENT SYMPTOMS WERE CONTINUING. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 21456318 ↗
• InjuryFeb 24, 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, PATIENT EXPERIENCED DOUBLE / SLANTED VISION, OUT OF FOCUS AND FUZZY VISION. PATIENT WAS DISSATISFIED WITH VISION. THE LENS WAS EXCHANGED WITH A NON-COMPANY INTRAOCULAR LENS AFTER THE INITIAL IMPLANT PROCEDURE. IN THE SURGEONS OPINION PRODUCT DID NOT CONTRIBUTE TO EVENT. CLINICAL REASON FOR EXPLANT WAS PATIENT NON-ADAPTIVE TO MULTIFOCAL IOL.

  Patient problems: Blurred Vision; Diplopia/Double Vision; Visual Disturbances

  MAUDE report 21447109 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM PATIENT STATING SHE EXPERIENCED SWIRLING IN HER VISION WHEN SHE SEES HEADLIGHTS AT NIGHT. THIS LASTS FOR ABOUT 5 SECONDS IN THE LEFT EYE ONLY.

  Patient problems: Blurred Vision; Posterior Capsule Opacification; Visual Disturbances

  MAUDE report 20736967 ↗
• MalfunctionNov 8, 2024Scratched Material; Scratched Material

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20642126 ↗
• InjuryMay 24, 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 DISTANCE VISION. THE LENS WAS EXCHANGED 1 MONTH FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 19390141 ↗
• MalfunctionMay 6, 2024Crack; Crack

  ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT LENS WAS REMOVED DURING INITIAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19247227 ↗
• MalfunctionApr 22, 2024Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INTRAOCULAR LENS WAS SCRATCHED IN INJECTOR ,THERE WAS PATIENT CONTACT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19152259 ↗
• InjuryOct 26, 2023Malposition of Device; Malposition of Device

  ADDITIONAL INFORMATION RECEIVED AND STATED THAT, UCVA WAS 20/25 , REFRACTION WAS PLANO + 0.25 X 19. ANTERIOR CHAMBER-UNREMARKABLE. IOL IN GOOD POSITION.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 18015149 ↗
• InjurySep 19, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT UNHAPPY WITH LENS PERFORMANCE.THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 17774295 ↗
• InjurySep 4, 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 DIZZINESS, NAUSEA, FEELING OFF-CENTER, CLINICAL REASON BEING INTRAOCULAR LENS IMPLANTATION AFFECTING ACTIVITIES OF DAILY LIVING. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Balance Problems; Dizziness; Nausea

  MAUDE report 17676179 ↗
• InjuryMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A TECHNICIAN REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION IN RIGHT EYE, PATIENT WAS UNHAPPY WITH VISION AT ALL DISTANCES, HAD DIFFICULTY FOCUSING ON ANYTHING. THE PATIENT ALSO COMPLAINED OF MILD DERMATOCHALASIS, PINGUECULA NASAL AND MODERATE ARCUS. THE LENS WAS EXPLANTED AND REPLACED WITH A NON-COMPANY LENS IN A SECONDARY PROCEDURE. PATIENT CONDITION WAS NOT RESOLVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision

  MAUDE report 16992013 ↗
• InjuryMay 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ADMINISTRATOR REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED AND REPLACED WITH ANOTHER IOL. ADDITIONAL INFORMATION RECEIVED STATED THAT PATIENT'S LEFT EYE WAS AFFECTED. THE LENS WAS EXPLANTED BECAUSE IT BECAME DISLOCATED, ROTATED OUT OF AXIS. PATIENT'S VISION WAS BLURRY AFTER IOL EXCHANGE.

  Patient problems: Insufficient Information

  MAUDE report 16945238 ↗
• InjurySep 16, 2022Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS FOUND THAT IOL WAS SCRATCHED. THE IOL WAS REPLACED WITH ANOTHER IOL DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15439396 ↗