Clareon CNWET4 (UDI 00380652466660)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652466660), received between Sep 20, 2024 and Jan 13, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2025Device Difficult to Setup or Prepare; Device Dislodged or Dislocated; Material Split, Cut or Torn; Device Difficult to Setup or Prepare; Device Dislodged or Dislocated; Material Split, Cut or Torn

  A PHYSICIAN REPORTED THAT THE PATIENT MYOPIC POST UVEITIS/POST VITRECTOMY DUE TO RETINAL DETACHMENT IN THE RIGHT EYE (OD), HAD DISCUSSED BEFOREHAND THAT IF THE PSC DID NOT COME OFF AUTOMATICALLY, WOULD LEAVE IT IN PLACE AND LASER IT LATER, AS THEY WERE UNSURE OF THE INTEGRITY OF THE CAPSULE. DURING SURGERY BACK UP INTRAOCULAR LENS (IOL) DID NOT LOAD PROPERLY AND A CRACK WAS VISIBLE AFTER IMPLANTATION AND NO OTHER BACK UP LENS SO THE LEFT THE LENS IMPLANTED. THE PATIENT HAS POOR VISION DUE TO HIS POSTERIOR CAPSULE OPACIFICATION (PCO), SO PHYSICIAN NOT SURE HOW MUCH THE CRACK BOTHERS HIM YET. HIS OTHER EYE DOES NOT NEED SURGERY SO, HESITANT TO DO AN INTRAOCULAR LENS (IOL) EXCHANGE IN THIS POST VITRECTOMY EYE, BUT A YAG (YTTRIUM ALUMINUM GARNET) IN A MONTH WILL MAKE AN IOL EXCHANGE EVEN HARDER AND PREVENT A LENS FROM BEING RE-IMPLANTED TOGETHER. ADDITIONAL INFORMATION RECEIVED AND IT STATES THAT THE FIRST LENS DID NOT GO IN PROPERLY WAS STUCK HALFWAY IN THE WOUND AND HAD USED USUAL 2.2MM SO, ENLARGED THE WOUND TO BE SAFE AND NOTICED WITH THAT LENS THAT IT FELT PARTICULARLY STIFF REMOVED DURING INITIAL PROCEDURE.

  Patient problems: Eye Injury; Visual Impairment

  MAUDE report 21135855 ↗
• InjuryJan 3, 2025Break; Crack; Device Difficult to Setup or Prepare; Break; Crack; Device Difficult to Setup or Prepare

  A PHYSICIAN REPORTED THAT THE PATIENT MYOPIC POST UVEITIS/POST VITRECTOMY DUE TO RETINAL DETACHMENT IN THE RIGHT EYE (OD), HAD DISCUSSED BEFOREHAND THAT IF THE PSC DID NOT COME OFF AUTOMATICALLY, WOULD LEAVE IT IN PLACE AND LASER IT LATER, AS THEY WERE UNSURE OF THE INTEGRITY OF THE CAPSULE. DURING SURGERY BACK UP INTRAOCULAR LENS (IOL) DID NOT LOAD PROPERLY AND A CRACK WAS VISIBLE AFTER IMPLANTATION AND NO OTHER BACK UP LENS SO THE LEFT THE LENS IMPLANTED. THE PATIENT HAS POOR VISION DUE TO HIS POSTERIOR CAPSULE OPACIFICATION (PCO), SO PHYSICIAN NOT SURE HOW MUCH THE CRACK BOTHERS HIM YET. HIS OTHER EYE DOES NOT NEED SURGERY SO, HESITANT TO DO AN INTRAOCULAR LENS (IOL) EXCHANGE IN THIS POST VITRECTOMY EYE, BUT A YAG IN A MONTH WILL MAKE AN IOL EXCHANGE EVEN HARDER, AND PREVENT A LENS FROM BEING RE-IMPLANTED TOGETHER. ADDITIONAL INFORMATION RECEIVED AND IT STATES THAT THE LENS WAS IMPLANTED TODAY HAD AN ISSUE WITH THE POSTERIOR HAPTIC I.E., WAS ABLE TO PUSH IT THROUGH, BUT THERE WAS YET AGAIN A SMALL CRACK BUT NEAR THE HAPTIC JUNCTION SO NOT VISIBLE TO THE PATIENT.

  Patient problems: Insufficient Information; Visual Impairment

  MAUDE report 21068827 ↗
• InjurySep 20, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED NO VISION BEYOND LIGHT PERCEPTION DAY 1 POST-OPERATIVE. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 01 DAY FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS COMPROMISED CAPSULE IOL FELL TO POSTERIOR CHAMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Capsular Bag Tear; Visual Impairment

  MAUDE report 20266309 ↗