Clareon CCWET0 (UDI 00380652405669)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652405669), received between Oct 18, 2022 and Apr 30, 2025 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (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. 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.

• MalfunctionApr 30, 2025Scratched Material; Scratched Material

  NON-HEALTHCARE PROFESSIONAL DURING SURGERY REPORTED THAT CARTRIDGES POSSIBLY ARRIVED CRACKED, THEN THEY PULLED ALL THE CARTRIDGES. ADDITIONALLY THEY HAD TWO LENSES THAT SEEMED TO BE SCRATCHED AND MENTIONED THAT AFTER TALKING WITH THE TEAM IF SOUNDED THAT THE LENS POSSIBLY SAT TOO LONG AND WAS TOO TIGHT TO PASS THROUGH THE CARTRIDGE. THEY GRABBED A NEW LENS BUT THE SAME CARTRIDGE AND NOTICED THE CRACK. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21935885 ↗
• MalfunctionApr 30, 2025Scratched Material; Scratched Material

  NON-HEALTHCARE PROFESSIONAL DURING SURGERY REPORTED THAT CARTRIDGES POSSIBLY ARRIVED CRACKED, THEN THEY PULLED ALL THE CARTRIDGES. ADDITIONALLY, THEY HAD TWO LENSES THAT SEEMED TO BE SCRATCHED AND MENTIONED THAT AFTER TALKING WITH THE TEAM IF SOUNDED THAT THE LENS POSSIBLY SAT TOO LONG AND WAS TOO TIGHT TO PASS THROUGH THE CARTRIDGE. THEY GRABBED A NEW LENS BUT THE SAME CARTRIDGE AND NOTICED THE CRACK. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21933445 ↗
• InjuryAug 8, 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 BLURRY VISION. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS VISUAL DISTURBANCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 19938905 ↗
• MalfunctionApr 8, 2024Scratched Material; Scratched Material

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS SCRATCHED. THE LENS WAS EXPLANTED AND REPLACED WITH SAME MODEL AND DIAPTOR IN THE INITIAL PROCEDURE . ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19059551 ↗
• MalfunctionDec 11, 2023Failure to Eject; Failure to Eject

  A FACILITY REPRESENTATIVE REPORTED STATING STUCK IN LOADER. THERE WAS PATIENT CONTACT. TYPE OF PROCEDURE WAS BEING PERFORMED WAS CATARACT. THE PROCEDURE COMPLETED THAT DAY AND THE PRODUCT WAS NOT AVAILABLE TO RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18300719 ↗
• InjuryNov 24, 2023Adverse 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 EXPERIENCED TERRIBLE NEAR VISION. ON PRE- OP VISIT, THE SURGEON INFORMED THAT PATIENT THAT AFTER SURGERY, THE PATIENT COULD NOT BE ABLE TO SEE ANYTHING CLOSE SUCH AS COMPUTER SCREEN, CELL PHONES, BOOK OR LABELS AT A STORE ON USING THE SPECIALTY LENS WITHOUT READING GLASSES. ON (B)(6) 2023, THE PATIENT HAD CATARACT SURGERY ON ONE EYE AND ON POST OPERATIVE VISIT, THE PATIENT INFORMED THE SURGEON THAT, HIS FAR VISION WAS GOOD BUT THE PATIENT COULD NOT READ ANYTHING CLOSE. THE DOCTOR INFORMED PATIENT THAT, HIS VISION WOULD BE BETTER AFTER A WHILE. A WEEK AFTER SURGERY ON HIS FIRST EYE, THE PATIENT HAD THE SECOND LENS IMPLANTED. SEVERAL WEEKS LATER, DURING THE POST-OP MEETING WITH ANOTHER DOCTOR, THE PATIENT AGAIN INFORMED HIM THAT HIS NEAR VISION WAS TERRIBLE AND I COULDN¿T READ ANYTHING WITHOUT READING GLASSES. THE SURGEON RECOMMENDED THAT, THEY COULD NOT DO ANYTHING ABOUT THE LENS WHICH WAS IMPLANTED BECAUSE ANOTHER SURGERY MAY CAUSE FURTHER DAMAGE. ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER AND STATED THAT, THE PATIENT WAS NOT HAPPY WITH THE LENSES. THERE ARE TWO MEDICAL DEVI

  Patient problems: Blurred Vision

  MAUDE report 18204261 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION REPORTS OF HAVING ISSUES WITH CONTRAST SENSITIVITY, BRIGHTNESS. FREQUENT IRRADIC CLOUDY VISION MOSTLY RELATED TO DRYNESS FOR WHICH THE PATIENT WAS USING DROPS WITH NO CHANGE IN VISION. ALSO THE FIELD OF VISION IN THE EYE IS DECREASED. AN EXPLANT OF THE LENS HAS BEEN PLANNED. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THE PATIENT HAD EXPERIENCED LACK OF BRIGHTNESS AND CLARITY AT NIGHT. ADDITIONAL INFORMATION HAS BEEN REQUESTED STATING THAT THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. THE VISION WAS STILL NOT CLEAR TO BE ABLE TO SEE LETTERS CLEARLY BUT IT WAS IMPROVING.

  Patient problems: Blurred Vision; Dry Eye(s); Visual Impairment

  MAUDE report 17478404 ↗
• InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT HAD EXPERIENCED BLURRY AND DOUBLE VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 15621944 ↗