Clareon CCWET0 (UDI 00380652405850)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00380652405850), received between Nov 23, 2022 and Nov 28, 2025 — classified as 10 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryNov 28, 2025Material Twisted/Bent; Material Twisted/Bent

  A FACILITY REPRESENTATIVE REPORTED THAT THE HAPTIC WAS DISFIGURED. THE IOL WAS EXPLANTED AND EXCHANGED FOR A SAME MODEL AND SAME DIOPTER COMPANY LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23671892 ↗
• MalfunctionJul 1, 2025Failure to Deliver; Failure to Deliver

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, INJECTOR LENS FAILED BEFORE INSERTING THE LENS INTO THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22370798 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS IMPLANT PROCEDURE THE PATIENT EXPERIENCED BLURRY VISION, HALOS AND GLARE. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. CLINICAL REASON MENTIONED AS BLURRY VISION, HALOS AND GLARE, NON-ADAPTATION.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21774891 ↗
• MalfunctionJan 30, 2025Scratched Material; Scratched Material

  A HEALTH CARE PROFESSIONAL REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SCRATCH ON PERIPHERAL WAS NOTICED. PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21272963 ↗
• InjuryJun 12, 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 CANT READ. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER COMPANY LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THERE WAS NO PATIENT HARM AFTER REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 19524778 ↗
• MalfunctionApr 25, 2024Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TWO SCRATCHES ON LENS OPTIC. THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND REPLACED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19180839 ↗
• InjuryOct 10, 2023Adverse 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 OTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS INCREASE IN ASTIGMATISM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 17906073 ↗
• InjuryAug 21, 2023Break; Malposition of Device; Break; Malposition of Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER 10 DAYS POST INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, IOL SHIFTED/DECENTERED IN THE PATIENT'S EYE. DURING SECONDARY SURGERY TO RECENTER THE IOL, IT WAS DISCOVERED THAT ONE OF THE HAPTICS WAS SEVERED OFF. THIS WAS NOT NOTICED UPON IMPLANTATION OR DAY ONE VISIT OR WEEK ONE VISIT. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE PATIENT INITIALLY COMPLAINED ABOUT WORSENING VISION. THE LENS WAS EXPLANTED WITH THE SAME MODEL AND DIOPTER LENS IN A SECONDARY PROCEDURE.

  Patient problems: Visual Impairment

  MAUDE report 17583101 ↗
• InjuryApr 28, 2023Adverse 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 WAS NOT ENOUGH WITH NEAR VISION. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 2 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANT MENTIONED AS POOR NEAR VISION. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND AS PER SURGEONS OPINION DECREASED CONTRAST DUE TO MULTIFOCALITY CONTRIBUTED TO THE EVENT. THERE WAS NO PATIENT HARM REPORTED AND SYMPTOMS WERE RESOLVED TO THE PATIENT.

  Patient problems: Blurred Vision

  MAUDE report 16831469 ↗
• InjuryApr 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT SINCE IMPLANTATION OF INTRAOCULAR LENS (IOL), HE HAD DOUBLE MONOCULAR VISION IN EYE PRODUCING GHOSTING ON THE MEDIAL SIDE OF VISION. ADDITIONALLY THERE WAS IMMEDIATE MASSIVE INCREASE IN INTRAOCULAR PRESSURE (IOP), WITH LOTS OF SMALL ROUND BLACK CIRCLES WITH CLEAR CENTERS, PRESSURE CAME DOWN WITH BURPING THE ANTERIOR CHAMBER AND HE WAS LEFT WITH MONOCULAR DOUBLE VISION. THE LEFT EYE HAS NO CIRCLES. THE CONSUMER MENTIONED THAT DOUBLE VISION WAS VERY DISTRACTING AND HARD TO FOCUS, WHITE SEEMS TO MAKE THE DOUBLE VISION MORE NOTICEABLE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision; Halo; Intraocular Pressure Increased; Visual Disturbances; Visual Impairment

  MAUDE report 16672061 ↗
• MalfunctionDec 29, 2022Failure to Advance; Device Damaged by Another Device; Failure to Advance; Device Damaged by Another Device

  A REGISTERED NURSE REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS BECAME STUCK IN THE CARTRIDGE AND THE INSERTION DEVICE SCUFFED THE LENS. THERE WAS PATIENT CONTACT OBSERVED. THE SURGERY WAS COMPLETED THE SAME DAY WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS RECEIVED STATING NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16069124 ↗
• InjuryDec 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REGISTERED NURSE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS BOTHERED BY SHADOWS AROUND OBJECTS. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED STATING PATIENT'S SYMPTOMS WERE RESOLVED. PATIENT WAS NOT HOSPITALIZED AS A RESULT OF THIS EVENT.

  Patient problems: Visual Impairment

  MAUDE report 16060136 ↗
• InjuryDec 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED FOLLOWING IMPLANTATION OF INTRAOCULAR LENS, PATIENT HAD DOUBLE MONOCULAR VISION PRODUCING GHOSTING ON THE MEDIAL SIDE OF VISION. ADDITIONAL INFORMATION WAS RECEIVED AND STATED WITH POST OPERATIVE CHECK ON THE DAY OF SURGERY, PATIENT HAD EXTREME INTRAOCULAR PRESSURE (IOP) INCREASED AND REQUIRED BURPING ONLY DURING THE SAME DAY. RIGHT EYE FOCUS IS NOT SHARP DUE TO THE GHOSTING AND DOUGHNUTS, AND CAN MAKE OUT THE LETTERS WITH AT 20/20 WITH GREAT DIFFICULTY. RIGHT EYE HAS MULTIPLE DOUGHNUT SHAPED FLOATERS. RIGHT EYE SYMPTOMS REMAIN UNCHANGED SINCE DAY AFTER IMPLANT. THE SURGEON USED THE LASER TO MAKE THE CUTS IN THE CORNEA, CORRECT SLIGHT ASTIGMATISM IN BOTH EYES AND BREAK UP THE CATARACT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Halo; Intraocular Pressure Increased; Visual Disturbances; Visual Impairment; Vitreous Floaters

  MAUDE report 15957031 ↗
• InjuryNov 23, 2022Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON REPORTED A NON-TORIC LENS HAD TORIC MARKINGS. NOTED UPON INSERTION OF LENS AND SURGEON WAS UNSURE OF WHAT TO DO. LEFT LENS IMPLANTED. ON ONE DAY POST OP PATIENT IS SEEING 20/200 AND UNABLE TO SEE INTERMEDIATE AT ALL. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOLLOWING THE INITIAL PROCEDURE.

  Patient problems: Blurred Vision

  MAUDE report 15851209 ↗