Clareon CNWTT0 (UDI 00380652408004)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380652408004), received between Apr 5, 2023 and Feb 12, 2025 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A NURSE REPORTED CRACK IN THE CENTER WHILE LOADING THE INTRAOCULAR LENS . THE PROCEDURE WAS COMPLETED ON THE SAME DAY USING AN EXCHANGE INTRAOCULAR LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21362826 ↗
• MalfunctionFeb 10, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A NURSE REPORTED CRACK IN THE CENTER WHILE LOADING THE INTRA OCULAR LENS. THE PROCEDURE WAS COMPLETED ON THE SAME DAY USING AN EXCHANGE INTRAOCULAR LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21344220 ↗
• InjurySep 26, 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, THE PATIENT EXPERIENCED WITH DRY EYES, BURNING PAIN. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 05 MONTHS 10 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS MECHANICAL COMPLICATIONS OF IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Dry Eye(s); Eye Pain

  MAUDE report 20310946 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT PATIENT'S VISION WAS FOUND BAD: WAXY VISION AFTER SURGERY. THE IOL WAS EXCHANGED FOR ANOTHER SINGLE FOCUS LENS MODEL 16 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 19215932 ↗
• InjuryApr 29, 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 CONTINUED VISION DECLINE. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS DRYNESS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Dry Eye(s)

  MAUDE report 19201264 ↗
• MalfunctionMar 19, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A NURSE REPORTED THAT, AFTER CATARACT SURGERY AND INSERTION OF THE IOL, IT WAS DISCOVERED THAT THERE WAS A FOREIGN SUBSTANCE ON THE JUNCTION BETWEEN THE OPTIC AND HAPTIC PARTS OF THE LENS. SINCE THIS WAS FOUND AFTER THE INSERTION HAD ALREADY BEEN COMPLETED, NO EXTRACTION WAS PERFORMED. THE HEAD OF THE HOSPITAL SUSPECTS THAT THIS COULD BE SOME FORM OF ADHESIVE MATERIAL, ALTHOUGH INITIALLY, IT WAS THOUGHT TO BE A SCRATCH OR AN UNEVEN SURFACE. BUT IT WAS LATER BELIEVED THAT IT WAS A FOREIGN SUBSTANCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18932211 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT, AFTER THE LENS REPLACEMENT, THE PATIENT EXPERIENCED VISUAL DISTURBANCE DAILY IN THE FORM OF FLASHING OR STROBING. THEREFORE THE PATIENT EXPERIENCED HEADACHE AND ANXIETY. THE PATIENT WAS HAVING THESE VISUAL DISTURBANCES REGULARLY WHICH IMPACTED THE QUALITY OF LIFE. HENCE THE WALKING HOURS OF THE PATIENT WAS MISERABLE. THE PATIENT IS NOW LOOKING FOR THE LENS REPLACEMENT ALTHOUGH IT MIGHT BE PAINFUL AND RISKY. ADDITIONAL INFORMATION RECEIVED STATING THAT, THE PATIENT WAS EXPERIENCING THE DISTURBANCE IN THE VISION EVERYDAY, GOING OUT WAS NOT COMFORTABLE. LIGHTING IN STORES, RESTAURANTS, DOCTOR'S OFFICES, HOMES AND MORE MOST ALL CAUSE THE FLASHING. OVERHEAD LIGHTING AND LIGHTING COMING FROM LAMPS AT A CERTAIN ANGLE GENERALLY GIVE THE GRIEF. THE PATIENT ALSO SEEM TO BE HAVING MORE BRIGHT FLASHES ON THE OUTSIDE OF THE EYE WHEN LIGHTS HIT AT CERTAIN ANGLE. SINCE THE QUALITY OF PATIENT IS AFFECTED, THE PATIENT IS PROCEEDING WITH LENS REPLACEMENT.

  Patient problems: Anxiety; Headache; Visual Impairment

  MAUDE report 17077166 ↗
• InjuryJun 5, 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 WAS UNSATISFACTORY WITH VISION. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. CLINICAL REASON FOR EXPLANT WAS ALSO MENTIONED AS UNSATISFACTORY VISION. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED, STATING THAT, PER THE SURGEON'S OPINION, THE LENS GAVE THE PATIENT PROBLEMATIC GLARE. THERE WAS NO PATIENT HARM.

  Patient problems: Visual Disturbances

  MAUDE report 17059165 ↗
• InjuryApr 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DISTANCE VISION BLURRY WHEN DRIVING AND NEAR VISION ALSO BLURRY. THE PATIENT HAS POOR QUALITY VISION AT ALL DISTANCES WITH AND WITHOUT CORRECTION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. IN THE SURGEON¿S OPINION, IOL DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THE PATIENT UNABLE TO ADAPT TO DIFFRACTIVE OPTICS. THERE WAS NO PATIENT HARM AND PATIENT MUCH HAPPIER WITH VISUAL QUALITY WITH MONOFOCAL IOL.

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

  MAUDE report 16683839 ↗