Clareon CCW0T3 (UDI 00380652431842)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652431842), received between May 23, 2023 and Apr 24, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT EXPERIENCED BLURRY VISION. THE LENS WAS REMOVED AND REPLACED WITH A MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS RESIDUAL MYOPIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 24982034 ↗
• MalfunctionMar 18, 2026Break

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS PATIENT CONTACT AND NO PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 24625936 ↗
• MalfunctionJul 14, 2025Failure to Deliver; Failure to Deliver

  A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WOULD NOT DEPLOY. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE INJECTOR CAUSED OR CONTRIBUTED TO THE EVENT AS THE TIP THAT PUSHES THE LENS OUT WAS BENT TOO MUCH. IT WAS FIXED AND NOW NO ISSUE WITH THE INJECTOR. THE SURGERY WAS COMPLETED USING ANOTHER LENS OF SAME MODEL AND DIOPTER AND THERE WAS NO PATIENT HAM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22493761 ↗
• MalfunctionJun 13, 2025Product Quality Problem; Product Quality Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON REPORTED THAT THERE WERE MARKS ON TORIC INTRAOCULAR LENS ARE NOT LINED UP WITH EACH OTHER. IT WAS ALSO REPORTED THAT THE MARKS WERE ABOUT 30 DEGREES OFF FROM ONE ANOTHER AND SUPERIOR MARK WAS LINED UP AS EXPECTED AT OR AROUND HAPTIC, INFERIOR MARK WAS ABOUT 30 DEGREES OFF AND DESCRIBED AS "GAPPED OUT". IT WAS STATED THAT THE SECOND LENS WAS OPENED AND THE MARKS WERE LINED UP AS EXPECTED. THE LENS WAS CUT OUT AND REPLACED WITH THE BACKUP LENS TO COMPLETE THE SURGERY. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22203208 ↗
• MalfunctionMar 24, 2025Dent in Material; Dent in Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTED JAGGED EDGES AFTER LENS WAS INSERTED, WHICH WOULD HAVE CAUSED THE PATIENT INJURY IF ROTATED. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH COMPANY LENS OF SAME MODEL AND DIOPTER. THERE WAS NO ISSUE OR HARM TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED STATING THAT IN THE SURGEON¿S OPINION LENS DAMAGED AT MANUFACTURING, CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21678008 ↗
• MalfunctionOct 4, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  A FACILITY REPRESENTATIVE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAD TEAR WHICH WAS NOTICED AFTER INSERTION. THE LENS WAS REMOVED AND IMPLANTED THE NEW LENS DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372551 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR VISION. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS POST OPERATION HYPEROPIA. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 19228477 ↗
• MalfunctionMay 23, 2023Defective Device; Defective Device

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT, THERE WAS DAMAGE OF IOL. THE LENS LEFT IN THE PATIENTS EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16982132 ↗