Clareon CNW0T4 (UDI 00380652402347)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652402347), received between Aug 18, 2022 and Sep 9, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Material Split, Cut or Torn

  A non-healthcare professional reported during intraocular lens (IOL) implant procedure, the surgeon noticed cracks 90 degrees from fold after the IOL was implanted into the eye. The lens was explanted during initial procedure. There was no patient harm.Additional information has been requested but is not available at the time of this report.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50692578 ↗
• MalfunctionMay 22, 2026Break; Inaccurate Delivery; Material Twisted/Bent

  A FACILITY REPRESENTATIVE REPORTED THAT DURING SURGERY, THEY NOTED THE DAMAGED LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE INITIAL LENS WAS LOADED INTO THE INJECTOR BY MY SCRUB TECHNICIAN. AS THE LENS WAS COMING OUT OF THE INJECTOR, IT APPEARED THE LENS WAS TRYING TO "FLIP". AS A RESULT, THE LENS INJECTOR WAS REMOVED FROM THE EYE. AS THE LENS WAS INJECTED OUT OF THE INJECTOR TO BE RELOADED FOR IMPLANTATION, THE TRAILING HAPTIC DISCONNECTED FROM THE OPTIC. A BACKUP LENS WAS USED AT THAT TIME. AFTER INSERTING THE LENS INTO THE EYE, THE TRAILING HAPTIC BECAME "STUCK" IN THE LENS INJECTOR. FORCEPS WERE USED TO GENTLY REMOVE THE TRAILING HAPTIC FROM THE INJECTOR, BUT THE HAPTIC WAS BROKEN APPROXIMATELY HALF WAY TO ITS CONNECTION ON THE OPTIC. PROCEDURE WAS COMPLETED ON THE SAME DAY. ISSUE NOTED WITH THE INITIAL LENS DURING PRIMING. SURGEON WAS UNCERTAIN WHAT CAUSED THE EVENT, IF FAULTY LENS OR ERROR IN LOADING. BOTH LENSES FELT "FRAGILE" COMPARED TO PREVIOUS LENSES USED AND HAD PREVIOUSLY HAD HAPTICS GET "STUCK" IN THE INJECTOR AND HAD ALWAYS BEEN ABLE TO GENTLY REMOVE THE HAPTIC FROM THE INJECTOR WITHOUT DIFFICULTY. SURGEONS PROGNOSIS WAS NOTED TO BE G

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25255096 ↗
• MalfunctionMay 22, 2026Break; Material Twisted/Bent

  A FACILITY REPRESENTATIVE REPORTED THAT DURING SURGERY, THEY NOTED THE DAMAGED LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE INITIAL LENS WAS LOADED INTO THE INJECTOR BY MY SCRUB TECHNICIAN. AS THE LENS WAS COMING OUT OF THE INJECTOR, IT APPEARED THE LENS WAS TRYING TO "FLIP". AS A RESULT, THE LENS INJECTOR WAS REMOVED FROM THE EYE. AS THE LENS WAS INJECTED OUT OF THE INJECTOR TO BE RELOADED FOR IMPLANTATION, THE TRAILING HAPTIC DISCONNECTED FROM THE OPTIC. A BACKUP LENS WAS USED AT THAT TIME. AFTER INSERTING THE LENS INTO THE EYE, THE TRAILING HAPTIC BECAME "STUCK" IN THE LENS INJECTOR. FORCEPS WERE USED TO GENTLY REMOVE THE TRAILING HAPTIC FROM THE INJECTOR, BUT THE HAPTIC WAS BROKEN APPROXIMATELY HALF WAY TO ITS CONNECTION ON THE OPTIC. PROCEDURE WAS COMPLETED ON THE SAME DAY. ISSUE NOTED WITH THE INITIAL LENS DURING PRIMING. SURGEON WAS UNCERTAIN WHAT CAUSED THE EVENT, IF FAULTY LENS OR ERROR IN LOADING. BOTH LENSES FELT "FRAGILE" COMPARED TO PREVIOUS LENSES USED AND HAD PREVIOUSLY HAD HAPTICS GET "STUCK" IN THE INJECTOR AND HAD ALWAYS BEEN ABLE TO GENTLY REMOVE THE HAPTIC FROM THE INJECTOR WITHOUT DIFFICULTY. SURGEONS PROGNOSIS WAS NOTED TO BE G

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25255093 ↗
• MalfunctionMar 2, 2026Material Split, Cut or Torn

  A NON-HEALTH CARE PROFESSIONAL REPORTED VIA REPLY CARD THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TEAR ON THE LENS WAS NOTICED. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24482603 ↗
• InjuryNov 21, 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 UNEXPECTED POST OPERATIVE REFRACTIVE ERROR. CLINICAL REASON BEING MENTIONED AS ABERRANT POSTERIOR OPTIC/ HAPTIC VAULTING (SMALL DIAMETER CAPSULAR BAG CONTRIBUTED TO POSTERIOR LENS VAULTING). THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL (ADVANCED TECHNOLOGY INTRAOCULAR LENS) FOLLOWING THE SECONDARY IMPLANT PROCEDURE. THERE WAS NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 20748169 ↗
• MalfunctionJul 29, 2024Dent in Material; Appropriate Device Problem Term/Code Not Available; Dent in Material; Appropriate Device Problem Term/Code Not Available

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE OBSERVED CRACKED LENS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATED THERE WAS A NOTCH TAKEN OFF THE LENS EDGE NEAR THE HAPTIC. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19850866 ↗
• MalfunctionAug 18, 2022Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL), TWO SCRATCHES WERE OBSERVED AT THE IOL OPTIC AFTER IMPLANTATION. THE SAMPLE IS NOT AVAILABLE AS IT STILL REMAINS IN THE PATIENT'S EYE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 15249027 ↗