Clareon CCWET0 (UDI 00380652405805)Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00380652405805), received between Jul 8, 2022 and Jun 26, 2026 — classified as 24 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED INADEQUATE VISION AND CLINICAL REASON VISION WAS NOT CLEAR ENOUGH FOR HIS SHOOTING EYE. THE IOL WAS EXCHANGED FOR MONOFOCAL NON-COMPANY REPLACEMENT LENS 07 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Blurred Vision

  MAUDE report 25633985 ↗
• InjuryApr 5, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT VISION WAS NOT CLEAR IN THE RIGHT EYE AND HALOS ARE WORSE. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 03 MONTHS 14 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS REFRACTION. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, 1 WEEK POST-OPERATIVE VISION WAS STILL BLURRY AND SEEING HALOS. VISION NEVER BECAME CLEAR. THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 24786612 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  AN OPHTHALMIC SURGEON REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE PATIENT HAD REPORTED BLURRY VISION, SHADOWS, AND AN INABILITY TO WORK CUTTING HAIR. THE CLINICAL REASON FOR EXPLANT WAS DYSPHOTOPSIA AND MECHANICAL COMPLICATIONS OF THE IOL. THE LENS WAS REMOVED AND REPLACED WITH A MONOFOCAL LENS IN A SECONDARY PROCEDURE." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24618060 ↗
• MalfunctionMar 7, 2026Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED SCRATCHES IN BOTH LENSES IN THE SAME CASE. THE LENSES WERE EXPLANTED AND REPLACED WITH ALTERNATIVE REPLACEMENT LENS WITH 21.0 DIOPTER DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ISSUES. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING SURGEON OBSERVED A SCRATCH ON 2 LENSES THAT WERE INJECTED INTO THE EYE, BOTH WERE REMOVED. THE LENS WAS REPLACED WITH A LENS WITHOUT ISSUE AND PROCEDURE COMPLETED ON SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24541103 ↗
• MalfunctionMar 7, 2026Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED SCRATCHES IN BOTH LENSES IN THE SAME CASE. THE LENSES WERE EXPLANTED AND REPLACED WITH ALTERNATIVE REPLACEMENT LENS WITH 21.0 DIOPTER DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ISSUES. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING SURGEON OBSERVED A SCRATCH ON 2 LENSES THAT WERE INJECTED INTO THE EYE, BOTH WERE REMOVED. THE LENS WAS REPLACED WITH A LENS WITHOUT ISSUE AND PROCEDURE COMPLETED ON SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24539865 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT REASON AND CLINICAL REASON AS MECHANICAL COMPLICATION. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE PATIENT ANGLE ALPHA IS ALMOST 6OU, HE WAS SEEING EDGE OF BUTTON ON THE LENS. IN THE SURGEONS OPINION, LENS CONTRIBUTED TO THE EVENT. THE IOL WAS EXPLANTED AND EXCHANGED FOR A NON COMPANY LENS. THERE WAS NO FURTHER IMPACT TO THE PATIENT. ISSUES WERE RESOLVED.

  Patient problems: Visual Disturbances

  MAUDE report 24496964 ↗
• InjuryOct 21, 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 HAD BEEN FRUSTRATED BECAUSE SHE HAD NOT BEEN ABLE TO READ WITHOUT HER GLASSES. THE CLINICAL REASON WAS MENTIONED AS MECHANICAL ISSUES WITH THE IOL. CATARACT SURGERY HAD BEEN PERFORMED FOR HER NARROW ANGLE GLAUCOMA, AND THE PATIENT HAD NOT BEEN FUNCTIONING WELL. THE IOL WAS EXPLANTED AND EXCHANGED WITH AN UNSPECIFIED MONOFOCAL LENS DURING THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THERE WAS NO FURTHER IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 23348981 ↗
• InjuryJul 16, 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 COULD NOT ADJUST WITH COMPANY LENS AND HAD VISION BLURRY. CLINICAL REASON FOR EXPLANT INCLUDED PATIENT WAS NOT SATISFIED WITH VISUAL OUTCOME. THE IOL WAS EXCHANGED FOR MONOFOCAL NON-COMPANY LENS 06 MONTHS 15 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 22521551 ↗
• MalfunctionMay 22, 2025Device Damaged by Another Device; Device Damaged by Another Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, UPON INSERTION SURGEON NOTED THAT THE LENS WAS SCRATCHED, BUT HE FELT THAT THE INSERTER ARM WAS BENT AND HAD DRAGGED OVER THE TOP OF THE LENS. HENCE THE LENS WAS REMOVED AND A BACKUP LENS WAS INSERTED USING A NEW CARTRIDGE AND LOADER. THERE WAS PATIENT CONTACT. PROCEDURE COMPLETED ON THE SAME DAY USING ANOTHER LENS.

  Patient problems: Insufficient Information

  MAUDE report 22069111 ↗
• InjuryApr 30, 2025Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT IOL HAD SHIFTED INFERIOR OR LENS WAS NOT IN PLACE IN THE RIGHT EYE. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 09 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS; THE DISPLACED IOL HAD BROKEN HAPTIC. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, DUE TO THE DAMAGE OF THE HAPTIC IOL WAS DISLOCATED. IN SURGEONS' OPINION IT IS UNCLEAR HOW OR WHEN THE HAPTIC WAS DAMAGED AS NO ISSUES WERE NOTED UPON INITIAL PLACEMENT OF THE IOL. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21934468 ↗
• InjuryFeb 19, 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 VISION IS NOT CRISP AND CLEAR. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS MODEL 3MONTHS AND 11 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS VISUAL DISTURBANCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21417910 ↗
• MalfunctionDec 11, 2024Defective Component; Defective Component

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS BROKEN INSIDE THE EYE AND WERE ABLE TO RETRIEVE THE LENS AND HAPTICS IN PIECES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20901621 ↗
• InjuryOct 28, 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 VISUAL ACUITY WAS WORSENING. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS MODEL 28 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MYOPIC SURPRISE AND -1.25 D OFF PLANO TARGET. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 20553086 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HE CANNOT READ PRINT WITHOUT READING GLASSES. HE HAS SPOKEN WITH DOCTOR REGARDING THIS, SHE PRESCRIBED READING GLASSES. HE WOULD LIKE COMPANY TO REACH OUT TO THE SURGEON FOR FURTHER INFORMATION OF HIS OUTCOME. ADDITIONAL INFORMATION RECEIVED, THE CAUSE OF EVENT WAS LIMITATION OF EXTENDED DEPTH OF FOCUS TECHNOLOGY. THERE WAS NO PATIENT HARM. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision

  MAUDE report 20552342 ↗
• InjuryJun 12, 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 IOL WAS EXCHANGED FOR ANOTHER LENS MODEL FOUR MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE REASON FOR EXPLANT WAS NOT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19523307 ↗
• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION AND GHOSTING. THE WAS EXCHANGED FOR THE SAME LENS MODEL 3 MONTHS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT MENTIONED AS INTOLERABLE ANISOMETROPIA AND IMBALANCE BETWEEN EYES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 19039764 ↗
• InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED WITH DESCRIPTION EXPLANTED IOL WITH REASON LENS EXCHANGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18518459 ↗
• MalfunctionOct 10, 2023Scratched Material; Scratched Material

  ADDITIONAL INFORMATION HAS BEEN RECEIVED INCLUDES PATIENT SYMPTOMS WERE RESOLVED AND THERE WAS NO PATIENT HARM.

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

  MAUDE report 17903259 ↗
• InjuryJul 3, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  ADDITIONAL INFORMATION WAS PROVIDED. ACCORDING TO THE SURGEON, THE OBJECT THAT WAS REMOVED WAS NOT IDENTIFIED AS A METAL ITEM. INSTEAD, IT WAS DESCRIBED AS A FOREIGN BODY THAT THE PATIENT MENTIONED AS BEING REFLECTIVE TO LIGHT DURING A POST-OPERATION EXAMINATION.

  Patient problems: Insufficient Information

  MAUDE report 17248862 ↗
• InjuryJun 26, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT HAD EXPLANT WITH COMPANY LENS AS THE PATIENT WAS UNHAPPY. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 2. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17197541 ↗
• InjuryJun 12, 2023Defective Device; Defective Device

  A NURSE REPORTED THAT AFTER IMPLANTATION OF INTRAOCULAR LENS (IOL), THE PATIENT HAD LENS COMPLICATIONS. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH A MONOFOCAL LENS. THE CLINICAL REASON FOR EXPLANT WAS MYOPIC OUTCOME. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 17106492 ↗
• InjuryMay 23, 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 EXPERIENCED REFRACTIVE SURPRISE AND INTOLERABLE ANISOMETROPIA . THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 1 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 16982780 ↗
• InjuryMay 17, 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 EXPERIENCED FUZZY VISION. THE IOL WAS EXCHANGED FOR UNSPECIFIED ATIOL LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT MENTIONED AS MECHANICAL COMPLICATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 16944288 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT AFTER IMPLANTATION OF INTRAOCULAR LENS (IOL), SINCE SURGERY, BARELY ABLE TO SEE OUT OF THE EYE. SHORTLY AFTER THE SURGERY, THE PHYSICIAN PERFORMED A YAG LASER. THE CONSUMER MENTIONED THAT THE PHYSICIAN HAS NOT TOLD THAT EYE WAS BEING TREATED WITH YAG, JUST MENTIONED THAT HE WAS CLEANING UP THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 16830487 ↗
• InjuryApr 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ACCOUNT MANAGER REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED REFRACTIVE SURPRISE. THE LENS WAS EXPLANTED AND REPLACED WITH OTHER LENS IN A SECONDARY PROCEDURE. ANTERIOR CELL GROWTH WAS NOTED ON LENS PRIOR TO EXPLANT. THE EXPLANT WAS NOT DUE TO THE ANTERIOR CELL GROWTH. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 16677195 ↗