Clareon CNWET0 (UDI 00380652405317)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380652405317), received between Dec 12, 2024 and Mar 5, 2026 — classified as 2 injuries, 7 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 18, 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.

• MalfunctionMar 5, 2026Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF SCRATCH WAS FOUND ON THE CENTRAL PART OF THE OPTIC. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING SURGERY AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24516226 ↗
• MalfunctionNov 24, 2025Break; Break

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS LOCATED IN THE CAPSULE BAG. THE SURGEON OBSERVED THAT ONE HAPTIC WAS TORN OFF BY TWO THIRDS FROM THE OPTICAL PART. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE LENS REMAINED IN THE CAPSULE BAG. THE PATIENT WAS DISCHARGED HOME WITH ARITHMANCY. THE PATIENT HAD AN APPOINTMENT. THE SURGEON DECIDED TO REIMPLANT THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23633159 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS REPORTED THAT THE PATIENT¿S VISION HAD NEVER IMPROVED. IT WAS ACTUALLY WORSE THAN BEFORE SURGERY AND HER VISION WAS STILL NOT GREAT. THE PATIENT HAD SECOND OPINION OUTSIDE OF HER SMALL TOWN. THE PATIENT HAD SEEN A RETINA DOCTOR WHO SAID HER EYE WAS HEALTHY. IT WAS ALSO TOLD TO HER THAT SHE NEEDS A YTTRIUM ALUMINUM GARNET (YAG) LASER TO CLEAN OFF THE "FLAP" OFF THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON (B)(6) 2025, THE PATIENT UNDERWENT A 10-DAY POSTOPERATIVE EVALUATION. THE PATIENT REPORTS THAT DISTANT VISION STILL APPEARS FUZZY AND THAT SMALL REGULAR PRINT IS BLURRY. THE CLIENT WANTS TO ENSURE THAT THE RIGHT EYE (OD) HAS HEALED PROPERLY BEFORE PLANNING ANY PROCEDURES FOR THE LEFT EYE (OS). THE PATIENT ALSO STATED SHE HAD EXPERIENCED SOME ACHING PAIN IN THE RIGHT EYE AND WAS USING ANTIBIOTIC AND CORTICOSTEROIDS. ON (B)(6) 2025 THE PATIENT REPORTED THAT RIGHT EYE VISION WAS STILL BLURRY. THE PATIENT WAS USING CORTICOSTEROID. THE PATIENT WAS TAKING ANALGESIC AND ANTIPYRETIC AND ANTACIDS. ON (B)(6) 2025 THE PATIENT REPORTED PERSISTENT BLURRY VI

  Patient problems: Blurred Vision; Eye Pain; Posterior Capsule Opacification

  MAUDE report 23346435 ↗
• InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAD BLURRY DISTANCE VISION AND MYOPIC OUTCOME. PATIENT INITIALLY COMPLAINED ON VISIT BUT DECIDED TO PROCEED WITH SECOND EYE CATARACT SURGERY FIRST AND SEE IF PATIENT TOLERATED SLIGHT MYOPIC OUTCOME LEFT EYE FOR MONOVISION. MYOPIC OUTCOME WAS AFFECTING DISTANCE VISION AND BEING ABLE TO SEE CLEARLY TO DRIVE. THE LENS WAS EXCHANGED WITH COMPANY OTHER MODEL LENS AFTER THE INITIAL IMPLANT PROCEDURE. IN THE SURGEON¿S OPINION THE PRODUCT DID NOT CONTRIBUTE TO THE EVENT AND MYOPIC OUTCOME CONTRIBUTED TO THE EVENT.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 22358185 ↗
• MalfunctionApr 24, 2025Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE AT THE TIME OF IMPLANTATION THE LENS IS AMPUTATED, THE LENS WAS REMOVED DURING THE INITIAL PROCEDURE AND A NEW ONE OF THE SAME DIOPTER IS REQUESTED. AGAIN THE LENS IS MOUNTED, USING THE SAME CARTRIDGE AND IT IS DECIDED TO CHANGE THE INJECTOR TO COMPANY, THE LENS IS GIVEN TO THE SURGEON AND AT THE TIME OF IMPLANTATION IT IS MARKED IN THE CENTRAL AREA OF THE OPTIC, THE LENS WAS REMOVED IN INITIAL PROCEDURE AGAIN AND A REQUEST FOR ANOTHER LENS, AND FOR THE THIRD TIME THE LENS IS MOUNTED IN THE COMPANY OF THE ADVISOR OF THE COMMERCIAL HOUSE, IT IS DELIVERED TO THE DOCTOR AND THE SURGICAL PROCEDURE IS COMPLETED WITH THE NEW LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21898998 ↗
• MalfunctionApr 24, 2025Device Damaged by Another Device; Device Damaged by Another Device

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE AT THE TIME OF IMPLANTATION THE LENS IS AMPUTATED, THE LENS WAS REMOVED DURING THE INITIAL PROCEDURE AND A NEW ONE OF THE SAME DIOPTER IS REQUESTED. AGAIN THE LENS IS MOUNTED, USING THE SAME CARTRIDGE AND IT IS DECIDED TO CHANGE THE INJECTOR TO COMPANY, THE LENS IS GIVEN TO THE SURGEON AND AT THE TIME OF IMPLANTATION IT IS MARKED IN THE CENTRAL AREA OF THE OPTIC, THE LENS WAS REMOVED IN INITIAL PROCEDURE AGAIN AND A REQUEST FOR ANOTHER LENS, AND FOR THE THIRD TIME THE LENS IS MOUNTED IN THE COMPANY OF THE ADVISOR OF THE COMMERCIAL HOUSE, IT IS DELIVERED TO THE DOCTOR AND THE SURGICAL PROCEDURE IS COMPLETED WITH THE NEW LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21898996 ↗
• 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 2 OF 2. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21678483 ↗
• MalfunctionMar 4, 2025Scratched Material; Scratched Material

  NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF LENS SCRATCHED AFTER IMPLANTATION. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21512949 ↗
• MalfunctionDec 12, 2024Material Discolored; Material Discolored

  A HEALTHCARE PROFESSIONAL REPORTED THAT E HAD NOTICED RESIDUE ON THE IOL INTRAOPERATIVELY WHICH DISAPPEAR POSTOPERATIVELY. THE LENS REMAINS IMPLANTED IN EYE.

  Patient problems: Insufficient Information

  MAUDE report 20915311 ↗