Clareon CCWTT0 (UDI 00380652413589)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380652413589), received between Jun 26, 2023 and Jul 14, 2025 — classified as 10 injuries, 2 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2025Material Deformation; Material Deformation

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED DEFECT IN LENS AND CARTRIDGE AFTER THE IOL WAS IMPLANTED INTO THE EYE. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE AND REPLACED WITH COMPANY LENS. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22493611 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION AND WAS NOT SATISFIED. THE LENS WAS EXPLANTED AND EXCHANGED WITH ANOTHER COMPANY LENS FOUR MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 22482063 ↗
• InjuryMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD INTOLERABLE NIGHTTIME STAR-BURSTING/HALOS. CLINICAL REASON BEING MENTIONED AS DYSPHOTOPSIA. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN MONOFOCAL LENS IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 21719697 ↗
• InjuryMar 6, 2025Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED THE LENS HAD ROTATED. PATIENT BROUGHT BACK TO THE OPERATING ROOM WITH THE INTENTION OF REPOSITIONING THE LENS. DOCTOR FOUND THE HAPTIC BROKEN SO THE LENS WAS EXCHANGED WITH UNSPECIFIED REPLACEMENT IOL AFTER THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION RECEIVED STATING THAT IN THE SURGEON'S OPINION BROKEN HAPTIC CONTRIBUTED TO EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21539628 ↗
• InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WITH BLUR. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 03 MONTHS 08 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS RESIDUAL MYOPIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 21239904 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT AFTER SURGERY, THE PATIENT HAD MALADAPTATION. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER UNSPECIFIED LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20178528 ↗
• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD MALADAPTATION. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS MODEL 5 MONTHS AND 13 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS MALADAPTATION. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20135941 ↗
• InjuryApr 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CERTIFIED OPHTHALMIC TECHNICIAN REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT COULD NOT GET USED TO THE LOSS OF CONTRAST WITH THE IMPLANTED IOL, NEITHER DISTANCE NOR NEAR VISION WAS CLEAR. THE LENS WAS REMOVED AND REPLACED WITH A NON-COMPANY LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS "SLIGHT HYPEROPIC RESULT".

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 19123939 ↗
• MalfunctionMar 14, 2024Dent in Material; Dent in Material

  A PHYSICIAN REPORTED THAT DURING AN (IOL) INTRAOCULAR LENS IMPLANTATION PROCEDURE, THE IOL WAS APPEARED TO HAVE A MANUFACTURER DEFECT. LENS APPEARED TO HAVE A CHIP IN THE ACRYLIC OF THE ROUNDED BALL AT THE END OF THE LEADING HAPTIC (ANTERIOR SURFACE). THE LENS WAS IMPLANTED SUCCESSFULLY WITHOUT COMPLICATION AND THE DEFECT WAS NOT A CONCERN FOR THE PATIENT'S OUTCOME."

  Patient problems: Insufficient Information

  MAUDE report 18904048 ↗
• InjuryJan 1, 2024Adverse 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 EXPERIENCED SEVERE HYPOTROPIA. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE LENS WAS EXCHANGED FOR A NON COMPANY LENS.

  Patient problems: Visual Disturbances

  MAUDE report 18423151 ↗
• InjurySep 20, 2023Defective Device; Defective Device

  WITH AVAILABLE INFORMATION, THE FILE WAS REVIEWED AND REASSESSED AND IT HAS BEEN REPORTED THAT THE IOL WAS EXCHANGED FROM A NON TORIC LENS TO A TORIC LENS OF SAME DIOPTER INDICATING THE CORRECT LENS POWER WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 17782046 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT AFTER THE INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT WAS SEEING SHADOWS. HENCE THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH MONOFOCAL LENS. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 17198160 ↗