Clareon™ CNWTT3 (UDI 00380652468534)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00380652468534), received between Oct 14, 2022 and Jun 5, 2026 — classified as 9 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2026Break; Material Split, Cut or Torn

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING CALIBRATION STAGE IT WAS IDENTIFIED THAT THERE WAS LENS DEFORMATION IN THE OPTIC AND THE HAPTICS PARTS. THE SURGERY WAS COMPLETED BY USING ANOTHER LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 25409796 ↗
• MalfunctionFeb 12, 2026Failure to Deliver

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS DAMAGED BY HANDPIECE INJECTOR. AT THE TIME OF IMPLANTATION, THE INTRAOCULAR LENS FOUND RESISTANCE AT THE EXIT OF THE INTRAOCULAR LENS. LENS WAS STUCK IN THE CARTRIDGE AND ONLY HALF OF THE LENS ENTERED THE ANTERIOR CHAMBER. THEREFORE, DECIDED TO REMOVE THE INTRAOCULAR LENS AND NOTICED AFTER THE EXTRACTION THAT LENS WAS A LITTLE DAMAGED (SCRATCHED) THEN IMMEDIATELY DECIDED TO REPLACE THAT INTRAOCULAR LENS WITH A NEW ONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE PROCEDURE WAS COMPLETED ON SAME DAY. THE PATIENT WAS PROGRESSING EXCELLENTLY ON THEIR THIRD POSTOPERATIVE DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24329570 ↗
• MalfunctionOct 29, 2025Failure to Deliver; Material Split, Cut or Torn; Failure to Deliver; Material Split, Cut or Torn

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT WHILE USING INJECTOR AND PLACING THE LENS INTO THE CARTRIDGE, THE LENS BECAME STUCK BETWEEN THE CARTRIDGE AND THE INJECTOR PLUNGER DURING THE INJECTION PHASE AND WAS FRAGMENTED. THE FRAGMENTED LENS WAS INJECTED INTO THE PATIENT'S EYE. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE AND REPLACED WITH UNSPECIFIED LENS. THE REMOVED LENS WAS DISCARDED INTO THE POUCH. THERE WAS NO PATIENT IMPACT OR HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23412247 ↗
• InjuryAug 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO PATIENT EXPERIENCED REFRACTIVE SURPRISE WITH HIGHER CYLINDER.THE IOL WAS REPLACED WITH UNSPECIFIED LENS APPROXIMATELY WITHIN A MONTH AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 22813148 ↗
• InjuryAug 8, 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 IOL WAS EXCHANGED WITH ADVANCED TECHNOLOGY INTRAOCULAR LENSES FOR THE REASON OF BLURRED VISION AND GLARE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22748318 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COULDN'T TOLERATE LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT LENS WAS EXCHANGED FOR COMPANY LENS MODEL AFTER 2 MONTHS. THE PATIENT WAS NOT ABLE TO READ DUE TO EDEMA AFTER LENS EXCHANGE.

  Patient problems: Visual Impairment

  MAUDE report 22612288 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT CANNOT SEE WITH CURRENT LENS. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS HYPEROPIC ERROR.

  Patient problems: Visual Impairment

  MAUDE report 22555569 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COULDN'T TOLERATE LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT LENS WAS EXCHANGED FOR COMPANY LENS MODEL AFTER 2 MONTHS. THE PATIENT WAS NOT ABLE TO READ DUE TO EDEMA AFTER LENS EXCHANGE.

  Patient problems: Visual Impairment

  MAUDE report 21643635 ↗
• InjuryJun 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT VISION WAS COMPROMISED BY DISLOCATED IOL.THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 4 MONTHS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS WEAK ZONULE / BAG WHICH DID NOT SUPPORT SINGLE PIECE TORIC LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 19519641 ↗
• MalfunctionMar 27, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  A NURSE REPORTED THAT DURING SURGERY, THEY INSERTED A LENS THAT HAD A ¿CRACK¿ IN IT. THEY TOOK THE LENS OUT AND USED ANOTHER ONE. THERE WAS NO PATIENT HARM. THERE WAS PATIENT CONTACT. TYPE OF PROCEDURE WAS BEING PERFORMED WAS CATARACT. THE PROCEDURE COMPLETED THAT DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18985043 ↗
• InjuryFeb 9, 2024Application Program Problem: Power Calculation Error; Malposition of Device; Application Program Problem: Power Calculation Error; Malposition of Device

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION AND DOUBLE VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 24 DAYS FOLLOWING THE INITIAL PROCEDURE.CLINICAL REASON FOR EXPLANT WAS MENTIONED AS IOL ROTATION AND POWER. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT PATIENT ALSO EXPERIENCED RESIDUAL ASTIGMATISM AND THE SYMPTOMS WERE RESOLVED. AS PER SURGEON OPINION, THE REFRACTIVE ERROR WAS CAUSED THE BLURRY VISION AND DOUBLE VISION.

  Patient problems: Blurred Vision; Diplopia/Double Vision; Visual Impairment

  MAUDE report 18675031 ↗
• MalfunctionFeb 7, 2023Malposition of Device; Malposition of Device

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT FOUND TO HAVE A REFRACTION OF-1.25+1.0X90. THE IMPLANTED IOL AXIS WAS CURRENTLY 10 DEGREES, REPORTER THINKING OF ROTATING WOUND NOT GET THE CLOSE RESULTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 16310048 ↗
• InjuryOct 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MATERIALS MANAGER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS EXPLANTED DUE TO NO ADAPTATION TO MULTIFOCAL OPTICS REPLACED WITH MONOFOCAL . ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 15604166 ↗