Clareon CNWET0 (UDI 00380652405225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380652405225), received between Mar 30, 2023 and Mar 2, 2026 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Product Quality Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, A MICROBUBBLE WAS OBSERVED ON THE OPTIC. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24482958 ↗
• MalfunctionFeb 27, 2026Material Split, Cut or Torn

  A SURGEON REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A TEAR AT THE EDGE OF THE OPTIC WAS OBSERVED AFTER IMPLANTATION. ADDITIONAL INFORMATION WAS REQUESTED AND SUBSEQUENTLY RECEIVED, INDICATING THAT NO UNUSUAL FINDINGS WERE NOTED UPON OPENING THE IOL PACKAGING. FOLDING AND IMPLANTATION WERE COMPLETED WITHOUT ANY ISSUES. THE LENS REMAINED IMPLANTED IN THE PATIENT'S EYE, AND THE PATIENT DID NOT EXPERIENCE ANY NEGATIVE CONSEQUENCES.

  Patient problems: Insufficient Information

  MAUDE report 24471849 ↗
• InjuryNov 11, 2025Break; Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON STATED HE HAD LOADED THE LENS INTO THE INJECTOR, AND THE PROCEDURE WAS PROGRESSING SMOOTHLY WITHOUT ANY ISSUES. HOWEVER, UPON INSERTION INTO THE EYE, HE NOTICED THAT ONE OF THE HAPTICS WAS BROKEN. AS A RESULT, THE LENS HAD TO BE REMOVED FROM THE PATIENT¿S EYE. ADDITIONAL INFORMATION WAS RECEIVED AS THE PATIENT WAS APHAKIC FOR TWO DAYS UNTIL THE REPLACEMENT LENS ARRIVED. THE PATIENT IS CURRENTLY DOING WELL.

  Patient problems: Insufficient Information

  MAUDE report 23521627 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT HAD NO CLARITY IN VISION, IT WAS DIM AND CLOUDY. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS MECHANICAL COMPLICATION DUE TO OCULAR LENS PROSTHESIS. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 23366407 ↗
• MalfunctionJul 30, 2025Material Discolored; Material Discolored

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SPIKES ON THE ANTERIOR SIDE OF THE LENS. THE LENS OPTICS HAD SPICULAE ON THEIR ANTERIOR FACE THAT COMPLETELY COVER THE OPTICS, THEY WERE VERY THIN TINY SPICULAE THAT APPEAR AS ON THE ANTERIOR FACE OF THE LENS AND THAT ARE NOT DUE TO SCRATCHES OR MANIPULATION. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THE PATIENT WHO UNDERWENT CATARACT SURGERY IN HIS LEFT EYE, ONE WEEK POSTOPERATIVELY CHANGES IN THE IOL WERE OBSERVED. THE PATIENT'S VISUAL ACUITY WAS 0.2, BUT THE PATIENT HAD POSTERIOR CAPSULE FIBROSIS, WHICH AWAITS A CAPSULOTOMY. THE PATIENT WAS TREATED WITH CORTICOSTEROID AND QUINOLONE ANTIBIOTIC. ADDITIONAL CLARIFICATION WAS RECEIVED BY STATING, THE PATIENT HAD OPACITY IN HIS POSTERIOR CAPSULE, BUT IN ADDITION, THE LENS HAD OPTICAL IMPERFECTIONS.

  Patient problems: Posterior Capsule Opacification

  MAUDE report 22666399 ↗
• MalfunctionApr 23, 2025Break; Break

  A NURSE REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE HAPTIC BROKE OFF. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 21892782 ↗
• MalfunctionApr 22, 2025Break; Break

  A NURSE REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE HAPTIC BROKE OFF. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 21881024 ↗
• MalfunctionDec 30, 2024Break; Break

  A HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF FAULTY LENS. ADDITIONAL INFORMATION RECEIVED STATING THAT LENS MISSING ONE HAPTIC. LENS PICKED UP WHILE LOADING, NOT INSERTED INTO EYE. THE SURGERY WAS COMPLETED ON SAME DAY BY USING DIFFERENT LENS. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21035481 ↗
• InjuryFeb 27, 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 BLURRED VISION AND WORSEN VISION. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL APPROXIMATELY THREE MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 18786835 ↗
• MalfunctionSep 20, 2023Scratched Material; Scratched Material

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS FOUND TO BE SCRATCHED. HENCE THE LENS WAS NOT IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17782661 ↗
• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE IN THE RIGHT EYE, THE VISION WAS 20/40 WITH NO INTERMEDIATE OR CLOSE VISION WITHOUT SIGNIFICANT BLURRING. THERE WAS LACK OF DEPTH OF FIELD IN THE RIGHT EYE. THE CONSUMER ALSO REPORTED THAT WITH REDUCED VISION FOR DISTANCE HE/SHE IS UNSURE IF IT IS SAFE TO DRIVE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 16643158 ↗