Clareon CNW0T3 (UDI 00380652409667)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652409667), received between Jul 31, 2024 and Jun 3, 2026 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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.

• MalfunctionJun 3, 2026Device Damaged by Another Device

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, CRACK WAS OBSERVED WHERE THE INJECTOR MEETS THE LENS. THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 25374449 ↗
• MalfunctionJan 12, 2026Material Split, Cut or Torn

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER THE LENS WAS INSERTED INTO THE CARTRIDGE, A CRACK WAS OBSERVED ON THE OPTIC. THE SURGERY WAS COMPLETED WITH UNSPECIFIED LENS. THERE WERE PATIENT CONTACT AND NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24035266 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD EXPERIENCED BLURRY VISION, DIFFICULTY SEEING DISTANCE AND READING, AND THE CLINICAL REASON WAS RESIDUAL PRESCRIPTION CAUSING BLURRY VISION. THE IOL WAS EXCHANGED FOR A MONOFOCAL LENS OF THE SAME MODEL, SAME DIOPTER, AND SAME COMPANY 3 MONTHS AFTER THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT, IN THE SURGEON'S OPINION, RESIDUAL PRESCRIPTION WAS THE CAUSE OF BLURRY VISION. THERE WAS NO FURTHER IMPACT TO THE PATIENT. IN THE SURGEON'S PROGNOSIS, THE IOL EXCHANGE WENT WELL.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 23970653 ↗
• MalfunctionFeb 5, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER IMPLANTATION, THE SURGEON NOTICED GLINT UPON INSERTION WHICH LOOKED LIKE TEAR. THE LENS WAS INSETED AND THE DOCTOR WAS ABLE TO ROTATE IT APPROPRIATELY. THERE WAS NO ISSUE WITH THE LENS BUT IT WAS REPORTED AS SAME ISSUE WITH SAME MODEL LENS WAS NOTICED IN OCTOBER WHICH RESULTED IN TEARING OF PATIENT¿S CAPSULE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21313517 ↗
• MalfunctionJan 31, 2025Failure to Deliver; Failure to Deliver

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE DOCTOR WAS INSERTING THE LENS INTO THE EYE BUT THE PLUNGER WOULD NOT ADVANCE SO IT WAS DECIDED TO REMOVE THE LENS AND GET A NEW ONE. THE LEADING HAPTIC DID ADVANCE TO THE EYE BUT NO MORE COULD BE TWISTED OUT. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21283931 ↗
• InjuryOct 1, 2024Adverse 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 EXPERIENCED ENDOPHTHALMITIS WHICH WAS CONFIRMED ON THE SECOND DAY AFTER SURGERY WITH PRESENCE OF KEY FINDINGS FIBRIN AND HYPOPYON. NO SURGICAL TREATMENT WAS PERFORMED BUT THE PATIENT WAS TREATED WITH STEROID EYE DROPS AND ANTIBACTERIAL EYE DROPS. THE LENS WAS REMAINED IN PATIENT EYE AND THE EVENT OUTCOME WAS RESOLVING. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING SUBJECTIVE SYMPTOMS OF BLURRED VISION FROM THE SECOND DAY AFTER SURGERY WITH INFLAMMATION FINDINGS, HYPEREMIA, KERATIC PRECIPITATES (KP) AND FIBRIN WITH NO IOL DEFECT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 2 OF 2.

  Patient problems: Endophthalmitis; Fibrosis; Hyperemia; Hypopyon; Keratitis

  MAUDE report 20341389 ↗
• InjuryJul 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATING THAT THERE WAS NO PATIENT HARM. AS PER SURGEONS OPINION PRODUCT NOT CONTRIBUTED TO EVENT. PATIENT'S OUTCOME WAS RECOVERED.

  Patient problems: Blurred Vision; Eye Pain

  MAUDE report 19869874 ↗