Clareon CNWET3 (UDI 00380652466479)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00380652466479), received between Feb 10, 2023 and Jun 16, 2026 — classified as 10 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2026Material Opacification; Scratched Material

  A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY, NOTICED A NICK ON THE LENS. ON THE FIRST POSTOPERATIVE DAY, SURGEON OBSERVED A CENTRAL SCRATCH ALONG WITH A CLOUDY, IRIDESCENT OPTIC.

  Patient problems: Insufficient Information

  MAUDE report 25519914 ↗
• InjuryMay 26, 2026Device Dislodged or Dislocated

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT'S VISUAL ACUITY WAS STILL BLURRY. THE LENS WAS EXCHANGED FOR AN UNKNOWN MONOFOCAL INTRAOCULAR LENS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON WAS IOL ROTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 25278840 ↗
• InjuryDec 5, 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 POOR VISION FOR DISTANCE. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH UNSPECIFIED MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS SUBOPTIMAL BCVA (BEST-CORRECTED VISUAL ACUITY). ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 23724704 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED AND REPORTED THAT THE IOL WAS EXCHANGED FOR THE SAME LENS MODEL BUT ONE DIOPTER MORE POWER INDICATING THE CORRECT LENS POWER WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 23366105 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT, THE PATIENT HAD THE LENS IN THE RIGHT EYE EXPLANTED ABOUT 5 WEEKS AGO. ALSO, THE LEFT EYE WAS NOT YET EXPLANTED BUT WILL LIKELY BE EXPLANTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21572195 ↗
• InjuryMar 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS UNHAPPY WITH VISION, HAD LOT OF VISUAL COMPLAINTS. CLINICAL REASON FOR THE EXPLANT IS VISUAL DISTURBANCE. THE IOL WAS EXCHANGED FOR UNSPECIFIED REPLACEMENT MONOFOCAL LENS 4 MONTHS 4 WEEKS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 21561468 ↗
• MalfunctionJan 9, 2025Break; Break

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING ROTATING THE LENS, THE UPPER HAPTIC WAS OBSERVED TO BE BROKEN, THEREFORE IT WAS DECIDED TO CUT THE LENS AND IMPLANTED ANOTHER INTRAOCULAR LENS WITH THE SAME CHARACTERISTICS DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS RECEIVED AND IT STATES THAT THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21110701 ↗
• InjuryJan 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 EXPERIENCED POOR INTERMEDIATE AND NEAR VISION. THE IOL WAS EXPLANTED AND EXCHANGED WITH ANOTHER LENS WITH SAME MODEL AND DIOPTER IN THE SECONDARY IMPLANT PROCEDURE. THERE IS NO IMPACT THE PATIENT.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 21100660 ↗
• InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS DISSATISFIED WITH VISUAL OUTCOME NEAR OR FAR. THE LENS WAS EXCHANGED FOR AN UNKNOWN MONOFOCAL TORIC INTRAOCULAR LENS, 5 MONTHS AFTER THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 20675578 ↗
• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT EXPERIENCED BLURRY VISION AT BOTH DISTANCE AND NEAR. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS POOR VISUAL QUALITY. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 20243378 ↗
• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WHO UNDERWENT CATARACT SURGERY ON HIS RIGHT EYE ON (B)(6) 2024. THE SURGERY ITSELF WAS ROUTINE, HOWEVER, THE POSTOPERATIVE PERIOD WAS UNEXPECTEDLY COMPLICATED BY THE DEVELOPMENT OF GRADE-IV CORNEAL ENDOTHELIAL EDEMA AND DESCEMET FOLDS THAT PERSISTED FOR NEARLY SIX WEEKS. THE PATIENT IS CURRENTLY IN THE PROCESS OF RECOVERY UNDER INTENSIVE TOPICAL STEROIDS AND SODIUM CHLORIDE THERAPY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Corneal Edema

  MAUDE report 19266741 ↗
• InjuryFeb 27, 2024Adverse 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, STATING HAVING BLURRY VISION ALL DISTANCES. PATIENT BEEN BACK TO THE SURGEON AND HE IS PERPLEXED AT THE OUTCOME AND DOES NOT HAVE ANY ANSWERS. PATIENT WAS A TARGET SHOOTER AND WAS NOT ABLE TO SEE CLEARLY AT ANY DISTANCE TO DO THAT. PATIENT ALSO HAD A YTTRIUM ALUMINUM GARNET ( YAG ) LASER DONE IN HIS RIGHT EYE ONLY WITH NO IMPROVEMENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision

  MAUDE report 18786782 ↗
• MalfunctionFeb 2, 2024Scratched Material; Scratched Material

  A NON-HEALTH CARE PROFESSIONAL REPORTED VIA REGULATORY AGENCY THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, UPON INSERTION OF LENS, SCRATCH NOTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18629026 ↗
• MalfunctionFeb 10, 2023Scratched Material; Scratched Material

  A PHYSICIAN REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION IT WAS NOTED THAT THE LENS WAS CRACKED NEAR THE CENTER AND NEEDED TO PERFORM AN LENS EXCHANGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16353273 ↗