Clareon CNWET3 (UDI 00380652466462)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652466462), received between May 3, 2024 and Sep 9, 2026 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Adverse 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 blurred vision at distance. The lens was exchanged for another lens model 03 months 07 days following the initial procedure. Clinical reason for explant was mentioned as post-operative refractive surprise with incorrect IOL power.Additional information has been requested but is not available at the time of this report.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 50692576 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT AFTER THE INTRAOCULAR IMPLANTATION SURGERY, THE PATIENT EXPERIENCED POOR VISION. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS OTHER MECHANICAL COMPLICATIONS DUE TO OCULAR LENS PROTHESIS.

  Patient problems: Visual Impairment

  MAUDE report 23331465 ↗
• MalfunctionOct 15, 2025Break; Break

  A HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, WHEN THE IOL WAS FOLDED INTO THE CARTRIDGE, DURING THE FEED IT WAS FOUND THAT THE REAR HAPTIC WAS TORN OFF. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ANOTHER LENS. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23301438 ↗
• InjuryJun 20, 2025Adverse 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 WAS VERY UNHAPPY WITH DISTANCE VISION, HAD YAG (YTTRIUM ALUMINUM GARNET) AND CURRENTLY STILL VERY FRUSTRATED TWO MONTH POST OPERATIVE. THE PATIENT HAD MYOPIC SURPRISE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED PATIENT WAS CURRENTLY WAITING FOR 3 MONTHS BEFORE LASER TOPUP. 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 22299152 ↗
• MalfunctionMar 13, 2025Scratched Material; Scratched Material

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER THE LENS WAS IMPLANTED IN THE EYE, IT WAS NOTICED THE LENS HAD A HUGE CRACK OR SCRATCH ACROSS THE CENTER, SURGEON STATED THAT HE DOES NOT KNOW IF THIS WAS AN ISSUE WITH THE TECH WHO LOADED THE LENS OR IT WAS A MANUFACTURER DEFECT. THE LENS WAS INSERTED INTO THE EYE AND HAD TO BE EXTRACTED AND REPLACED DURING INITIAL PROCEDURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21592242 ↗
• InjuryJan 3, 2025Adverse 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 WITH POOR VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 29 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS MYOPIC SURPRISE. ADDITIONAL INFORMATION HAS RECEIVED IN THE SURGEON¿S OPINION POSSIBLY LENS COULD HAVEN BEEN OFF. THERE IS NO IMPACT TO THE PATIENT. INADEQUATE A SCAN MAY HAVE ALSO CONTRIBUTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Visual Impairment

  MAUDE report 21065116 ↗
• MalfunctionJul 5, 2024Dent in Material; Material Split, Cut or Torn; Dent in Material; Material Split, Cut or Torn

  A OTHER HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS HAD A TEAR ON THE PERIPHERAL EDGE OF THE LENS. THIS LENS ALSO SHOWED AN IMPERFECTION ON THE PERIPHERAL OF THE LENS HOWEVER THE SURGEON FELT IT WOULD NOT NEGATIVELY IMPACT THE VISUAL OUTCOME FOR THE PATIENT SO DECIDED TO COMPLETE THE SURGICAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19679191 ↗
• InjuryMay 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, CONSUMER FELT LIKE "A HORSE WITH BLINDERS ON" ON THE LEFT SIDE. HER PERIPHERAL VISION IN THE LEFT EYE WAS AFFECTED. CONSUMER LIKES TO DO POLKA DANCE AND WAS FEELING UNSAFE THAT SOMEONE IS COMING FROM THE LEFT AND CAN'T SEE THEM IN TIME. PATIENT REACTED TO PRESERVATIVE IN THE CORTICOSTEROID DRUG, FOR THAT PATIENT USED ARTIFICIAL TEARS EYE DROPS. PATIENT HAD PSEUDOEXFOLIATION.

  Patient problems: Visual Disturbances

  MAUDE report 19237273 ↗