Clareon CCWET0 (UDI 00380652405843)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00380652405843), received between Aug 13, 2022 and Mar 3, 2026 — classified as 9 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (4 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.

• MalfunctionMar 3, 2026Material Split, Cut or Torn

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS MICRO CRACK ON LENS. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE LENS WAS REMOVED FROM THE PATIENT EYE AND A SIMILAR LENS OF SAME MODEL WAS IMPLANTED AND COMPLETED THE PROCEDURE ON THE SAME DAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496813 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE IOL WAS REPLACED WITH ANOTHER LENS FROM THE SAME COMPANY, WITH 1.5 DIOPTERS LESS POWER. BASED ON THIS INFORMATION, THE FILE WAS REVIEWED AND REASSESSED, AND IT HAS BEEN DETERMINED THAT THERE WAS NO REPORTED DEFECT OR FAULT WITH THE COMPANY PRODUCT.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 23691737 ↗
• MalfunctionJun 27, 2025Break; Break

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE,TORN OR BROKEN HAPTIC. LENS WAS REMOVED AND REPLACED DURING INITIAL PROCEDURE. THE PROCEDURE COMPLETED ON THE SAME DAY WITH BACKUP LENS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346611 ↗
• InjuryJun 20, 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 CONTINUED BLURRED VISION IN THE AFFECTED EYE. THE CLINICAL REASON FOR EXPLANT WAS THAT THE REFRACTIVE OUTCOME WAS UNSATISFACTORY TO THE PATIENT. THE IOL WAS EXCHANGED FOR AN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) 1 MONTH AND 19 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 22302272 ↗
• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED MILD DIFFUSE FLAP EDEMA AND GRADE 2 POSTERIOR CAPSULE OPACIFICATION (PCO) WITH STRIAE THROUGH VISUAL AXIS. HENCE YTTRIUM ALUMINUM GARNET (YAG) WAS PERFORMED TO TREAT PCO. IN THE SURGEON'S OPINION, THE POSSIBLE CARTRIDGE MATERIAL OR THE LENS WOULD HAVE CAUSED THE EVENT. THERE WAS NO PATIENT HARM. IN THE SURGEON'S OPINION, THE PROGNOSIS OF THE PATIENT WAS GOOD.

  Patient problems: Corneal Edema; Posterior Capsule Opacification

  MAUDE report 22174413 ↗
• MalfunctionApr 21, 2025Scratched Material; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF SCRATCH ON INTRAOCULAR LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21876763 ↗
• InjuryJan 29, 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 WITH POOR VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 10 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS DISSATISFIED WITH VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 21263034 ↗
• InjuryNov 12, 2024Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO PATIENT EXPERIENCED A LINE WITH COLOR ABERRATION IN VISION. CLINICAL REASON FOR EXPLANT WAS REPORTED TO BE AS "LENS APPEARED DAMAGED WITH POSSIBLE SCRATCH THROUGH THE CENTER. THE IOL WAS REPLACED WITH UNSPECIFIED LENS APPROXIMATELY THREE MONTHS AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 20665078 ↗
• MalfunctionNov 11, 2024Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS DAMAGED BY INJECTOR OR SCRATCHED IOL AND NOTICED AFTER PLACEMENT IN EYE. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20651297 ↗
• InjuryNov 23, 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 WAS UNHAPPY WITH VISION. THE PATIENT EXPERIENCED HALOS, MORE AT NIGHT, HALO GETS BIGGER THE FARTHER AWAY THE OBJECT (20-30+ FEET) AND ALSO EXPERIENCING NEGATIVE DYSPHOTOPSIA. THE SURGEON PRESCRIBED BRIMONIDINE TO TRY FOR NIGHT DRIVING 20 MINUTES BEFORE LEAVING THE HOUSE TO HELP WITH THE HALOS. BUT THE PATIENT DID NOT TRIED. THE PATIENT WAS UNABLE TO DRIVE AT NIGHT. THE DOCTOR SUGGESTED YAG LASER BUT WILL NOT DO IT UNTIL PATIENT DECISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 18198537 ↗
• InjuryMar 15, 2023Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD AN HYPEROPIC OUTCOME OF +2.25. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THE PATIENT WAS NOT DILATED AT POST OPERATION. THE NEXT DAY THEY DID AN IOL EXPLANT AND DURING SURGERY, ONCE PATIENT WAS DILATED, IT WAS NOTED THE IOL LEADING HAPTIC WAS "FRACTURED" AND IOL WAS DISLODGED AND DECENTERED AND WHICH WAS SEEN ON THE MONITOR. THE IOL WAS SHIFTED TO THE RIGHT AND THE EDGE OF THE LENS WAS IN VISUAL AXIS. DURING THE EXPLANT, THE SURGEON WENT TO GRAB THE LEADING HAPTIC WITH THE FORCEPS AND IT CAME OFF. SURGEON EXPLAINED TO THE REPORTER USUALLY HE WOULD HAVE TO CUT THE HAPTIC. THE LENS WAS REMOVED WITHOUT COMPLICATION AND A NEW LENS WAS IMPLANTED AFTER MEASURING WITH THE SYSTEM. THE PATIENT HAD REQUESTED TO HAVE BETTER READING VISION IN THIS EYE SO A DIFFERENT POWER LENS WAS USED. PATIENT IS VERY HAPPY WITH THE NEW LENS. ALSO REPORTED THAT, DURING THE INITIAL SURGERY, THE HAPTIC FRACTURE WAS NOT NOTED. THE REPORTER IS THE SCRUB TECH WHO WAS IN BOTH SURGERIES. SHE SAID ON IMPLANTATION THEY HOLD THE TRAILING HAPTIC SO THERE WAS NO WAY THEY CAUSED THE ISSUE TO THE LEADING HAPTIC.

  Patient problems: Visual Impairment

  MAUDE report 16545184 ↗
• MalfunctionFeb 24, 2023Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DOCTOR NOTICED A MARK OR SCUFF ON THE LENS ONCE INSERTED INTO THE PATIENT EYE. THE LENS WAS REMOVED AND REPLACED WITH NEW LENS ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16436179 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED GLARE AND DYSOPHTOPSIA. THE IOL WAS EXCHANGES WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 16335417 ↗
• InjuryAug 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT, FOLLOWING INTRAOCULAR LENS IMPLANT (IOL) PROCEDURE, THE PATIENT WAS HAVING BLURRED VISION. THE IOL WAS EXCHANGED FOR ANOTHER LENS APPROXIMATELY 2 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON GIVEN FOR THE EXPLANT WAS ¿ANISOMETROPIA¿. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 15222642 ↗