Clareon CCWTT4 (UDI 00380652457958)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380652457958), received between May 24, 2023 and May 30, 2025 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THE IOL REPLACED WITH COMPANY LENS USING COMPANY D CARTRIDGE AND VISCOELASTIC WITHOUT ANY IMPACT TO THE PATIENT.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 22116490 ↗
• MalfunctionNov 29, 2024Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS WAS SCRATCHED DURING LOADING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20809230 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATING THAT THE LENS WAS EXCHANGED WITH COMPANY OTHER MODEL WITH DIFFERENT DIOPTER. IN THE SURGEON'S OPINION PRODUCT CONTRIBUTED TO EVENT. GLARE AND HALOS RESOLVED AFTER LENS EXCHANGE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances; Visual Impairment

  MAUDE report 20798514 ↗
• InjuryNov 22, 2024Adverse 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 EXPERIENCED WITH BLURRED VISION AND DOES NOT WANT GLASSES. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 03 MONTHS 07 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS REFRACTION RESULT MYOPIA WITH ASTIGMATISM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Corneal Edema; Visual Impairment

  MAUDE report 20755693 ↗
• InjuryNov 14, 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 EXPERIENCED BLURRY VISION. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS MODEL 24 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REFRACTIVE ERROR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 20689232 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT EXPERIENCED BLURRY VISION AT ALL FOCAL POINTS. THE PATIENT WAS UNABLE TO ADAPT TO THE IMPLANTED LENS. THE LENS WAS REMOVED AND REPLACED WITH A MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS MECHANICAL MALFUNCTION. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 19380653 ↗
• InjuryNov 3, 2023Adverse 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 EYE WAS SWELLING FOR SEVERAL MONTHS AFTER THE CATARACT SURGERY. THE PATIENT EXPERIENCED REFLECTION OF BROKEN GLASSES DURING THE NIGHT ESPECIALLY AT THE RIGHT CORNER. THERE WERE FLOATERS AND THIN FISHNET STOCKING LIKE MATERIALS. THE OPHTHALMOLOGIST SAID THE VISION WOULD IMPROVE WITH TIME AND SUGGESTED PREDNISOLONE TO CONTROL OR RATHER TO PREVENT THE SWELLING. THE VISION WAS IMPROVING BUT STILL NEED THE GLASSES FOR LONG DISTANCE AND WAS USING BOTH READING AND DRIVING GLASSES TO PERFORM THE DAILY FUNCTIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Corneal Edema; Visual Disturbances; Vitreous Floaters

  MAUDE report 18067130 ↗
• MalfunctionJun 8, 2023Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER IMPLANTING THE LENS, IT HAD A SCRATCH ON IT. THE LENS WAS REMOVED DURING INITIAL PROCEDURE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17085510 ↗
• InjuryMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED ABOUT AN LENS EXPLANT A YEAR AFTER INITIAL PROCEDURE DUE TO BLURRY INTERMEDIATE AND DISTANCE VISION. THE LENS WAS REPLACED WITH A NON-COMPANY LENS. THE PATIENT SYMPTOMS WERE RESOLVED.

  Patient problems: Blurred Vision

  MAUDE report 16990259 ↗