Clareon CNWET0 (UDI 00380652405331)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380652405331), received between Oct 23, 2022 and Aug 31, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Failure to Deliver

  Patient problems: Insufficient Information

  MAUDE report 50522742 ↗
• MalfunctionMar 2, 2026Packaging Problem; Material Split, Cut or Torn

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN FOLDING THE INTRAOCULAR LENS, THE NON-HEALTHCARE PROFESSIONAL NOTICED THAT THE LENS WAS GLUED TO THE CAP AND NOT THE BASE, AND IT ALSO HAD A DEFECT (SCRATCH) ON THE OPTICAL PART. THE SURGEON WAS ADVISED TO REPLACE THE LENS WITH THE SAME REFERENCE AND POWER. THERE WERE NO PATIENT CONTACT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480345 ↗
• InjuryFeb 13, 2026Use of Incorrect Control/Treatment Settings; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT, FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS UNABLE TO SEE. THE PATIENT COULD NOT RECOGNIZE STOP SIGNS, WAS UNABLE TO PLAY POOL, AND EXPERIENCED A LOT OF GLARES. ON (B)(6) 2025, THE PATIENT PRESENTED FOR POST-OPERATIVE FOLLOW-UP. THE PATIENT REPORTED THAT THAT QUALITY WAS ANNOYING, SEVERITY WAS DESCRIBED AS MINOR. THE PATIENT HAD CLEAR VISION FOR A LITTLE WHILE BUT IT WAS REALLY FUZZY AND WAS SCRATCHY (REPORTED AS YESTERDAY). THE PATIENT WAS ON PROPHYLAXIS TREATMENT WITH CORTICOSTEROIDS, FLUOROQUINOLONE ANTIBIOTIC AND NONSTEROIDAL ANTI-INFLAMMATORY DRUG (NSAID). THE PATIENT EXPERIENCED EDEMA. THE PATIENT WAS INSTRUCTED TO NOT RUB THEIR EYE AND TO USE DROPS AS DIRECTED. ON (B)(6) 2025, THE PATIENT PRESENTED FOR THE ONE-WEEK POST-OPERATIVE CONSULTATION. THE PATIENT STATED QUALITY WAS IMPROVING. PATIENT DESCRIBED FOLLOWING SIGNS AND SYMPTOMS: VISION WAS STILL BLURRY DISTANCE AND NEAR AND IT FEELS SCRATCHY LIKE SOMETHING WAS IN IT. THE PATIENT WAS CONTINUED USING CORTICOSTEROIDS, FLUOROQUINOLONE ANTIBIOTIC AND NONSTEROIDAL ANTI-INFLAMMATORY DRUG AS A PROPHYLAXIS TREATMENT. THE PATIENT WAS USING COMPANY LUBRICANT E

  Patient problems: Blurred Vision; Corneal Edema; Dry Eye(s); Eye Irritation; Eye Pain; Visual Disturbances; Visual Impairment

  MAUDE report 24331588 ↗
• MalfunctionJun 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS MOUNTED IN A COMPANY CARTRIDGE AND COMPANY INJECTOR AND CAME TO KNOW THAT DOCTOR EVIDENCED A RUPTURE IN THE OPTICAL AREA AND REQUESTS A LENS CHANGE. WHICH WAS PERFORMED AND IMPLANT IN THE PATIENT WITHOUT A PROBLEM. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THERE WAS NO PATIENT CONTACT AND NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22129482 ↗
• MalfunctionMar 24, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  PHYSICIAN REPORTED AFTER INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE CRACKS PRESENTED IN THE INTRAOCULAR LENS. SURGEON STATED THAT THE CRACK IS NOT IN THE VISUAL AXIS SO DID NOT EXPLANT. IT WAS STATED THAT SKILLED NURSES IMPLANTED USING DIFFERENT CARTRIDGES AND HE BELIEVES SOMETHING IS WRONG WITH THE INTRAOCULAR LENS (IOL) MATERIAL. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 1 OF 2. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21678482 ↗
• MalfunctionMar 24, 2025Break; Break

  A HEALTHCARE PROFESSIONAL REPORTED THAT WHEN PREPARING THE LENS FOR A SURGERY THEY NOTICED THAT ONE OF THE HAPTICS WAS BROKEN. THEY SUSPENDED THE SURGERY ON THAT EYE AND OPTED TO OPERATE ON THE PATIENT'S OTHER EYE. THE SURGERY WAS RESCHEDULED FOR (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21678005 ↗
• InjurySep 26, 2024Adverse 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 AND HALF A 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

  MAUDE report 20308378 ↗
• MalfunctionJul 22, 2024Defective Device; Defective Device

  A HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF DEFECTIVE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19792456 ↗
• MalfunctionMar 15, 2024Crack; Crack

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS CRACKED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18911438 ↗
• MalfunctionOct 23, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AN OPHTHALMOLOGIST REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SMALL IRIDESCENT, ALMOST METALLIC LIKE FLECKS ON AND WITHIN THE LENS ITSELF WAS FOUND. ADDITIONAL INFORMATION WAS RECEIVED STATING ISSUE WITH COMPLAINT PRODUCT WAS NOTICED UPON INSERTION INTO EYE. IT WAS REPORTED THAT THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15656497 ↗