Clareon CNW0T3 (UDI 00380652409575)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652409575), received between Aug 30, 2022 and Aug 21, 2025 — classified as 3 malfunctions.

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

• MalfunctionAug 21, 2025Failure to Deliver; Failure to Deliver

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY, AT THE LENS ADVANCEMENT STAGE, THE LENS BECAME LODGED IN THE CARTRIDGE AND THE SURGEON DID NOT PROCEED WITH IMPLANTATION. THE PATIENT WAS NOT AFFECTED, AND ANOTHER UNSPECIFIED REPLACEMENT LENS WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22860703 ↗
• MalfunctionMar 24, 2025Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS HAD AN UNSPECIFIED ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE LENS WAS LOADED INTO COMPANY CARTRIDGE THEN PLACED IN AN INSERTER, IT WAS THEN INJECTED INTO THE EYE AND A SCRATCH WAS NOTICED ON THE LENS. HOW THE SCRATCH GOT THEIR REPORTER DID NOT HAVE AN ANSWER FOR. LENS WAS THEN REMOVED AND REPLACED WITH A NEW UNSPECIFIED LENS DURING INITIAL PROCEDURE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21675978 ↗
• MalfunctionAug 30, 2022Unintended Ejection; Unintended Ejection

  A DOCTOR REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE LENS INSERTED INTO THE CARTRIDGE AND INSERTED WITH THE INJECTOR, THE PLUNGER WAS ADVANCED FORWARD WITH THE FILLED IOL AS USUAL, BUT SUDDENLY THE IOL WAS SHOT OFF FROM THE CARTRIDGE AND WAS INSERTED INTO THE EYE, THE SURGEON TRIED TO INSERT IOL WITH SLOWLY ROTATING THE PLUNGER, BUT IOL WAS INSERTED BEFORE THE LAST PUSH. SINCE IT DID NOT ENTER IN THE BAG WITH ONE ACTION, IT WAS REPOSITIONED WITH A HOOK. THE SURGERY WAS COMPLETED WITHOUT THE PRODUCT REPLACEMENT. LENS WAS STILL IMPLANTED INTO THE PATIENT'S EYE. NO FURTHER INFORMATION AVAILABLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15318393 ↗