Clareon CCWET0 (UDI 00380652405751)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00380652405751), received between Dec 13, 2022 and Jul 31, 2026 — classified as 16 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2026Device Dislodged or Dislocated

  A non-healthcare professional reported that following intraocular lens (IOL) implantation, a capsular tear occurred in the capsular bag, resulting in lens migration. Consequently, the IOL was removed and replaced with an unspecified anterior chamber lens during a secondary procedure.No further details are expected, as the reporter has no more information available.

  Patient problems: Capsular Bag Tear

  MAUDE report 50099457 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR INTERMEDIATE VISION. CLINICAL REASON BEING MENTIONED AS PRIOR MYOPIC LASIK (LASER-ASSISTED IN SITU KERATOMILEUSIS) AND SMALL REFRACTIVE SURPRISE. THE IOL WAS EXPLANTED AND EXCHANGED WITH AN UNSPECIFIED ATIOL (ADVANCED TECHNOLOGY INTRAOCULAR LENS) IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 24468983 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS HAVING POOR VISION. CLINICAL REASON IS MALADAPTION. THE IOL WAS EXCHANGED FOR NON-COMPANY MONOFOCAL INTRAOCULAR LENS 5 MONTHS 2 WEEKS 1 DAY FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THERE WAS NO PATIENT IMPACT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS ASSOCIATED TO RIGHT EYE.

  Patient problems: Visual Impairment

  MAUDE report 23977583 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED AND REPORTED THAT THE IOL WAS EXCHANGED FOR THE DIFFERENT LENS MODEL BUT HALF A DIOPTER LESS POWER INDICATING THE CORRECT LENS POWER WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 20698528 ↗
• InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED VISUAL DISTURBANCES, HALOS, CANNOT DRIVE AT NIGHT. CLINICAL REASON FOR EXPLANT WAS UNSPECIFIED VISUAL DISTURBANCES. THE IOL WAS EXCHANGED FOR NON-COMPANY MONOFOCAL LENS MODEL 1 MONTHS 24 DAY FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Impairment

  MAUDE report 20458187 ↗
• InjurySep 20, 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 EXPERIENCED HAZY VISION AND CLINICAL REASON FOR EXPLANT BEING PATIENT DISSATISFIED WITH VISUAL ACUITY. THE IOL WAS EXPLANTED AND EXCHANGED FOR A LIGHT ADJUSTABLE LENS (LAL) FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT HAZY VISION WAS EXPERIENCE AT 1 DAY POST OPERATIVELY. NON ADAPTABILITY WAS REPORTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 20267169 ↗
• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT HAD DIMINISHED VISION AND GLARE. THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) 3 MONTH AND 6 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON WAS MECHANICAL COMPLICATION DEFECT OF IOL. ADDITIONAL INFORMATION RECEIVED STATING THAT IN THE SURGEON¿S OPINION, THE PRODUCT CONTRIBUTED TO THE EVENT. THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 20246998 ↗
• InjuryJul 24, 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 HAD POOR VISION (POST LASIK) WITH MULTIFOCAL. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS HIGH ORDER ABERRATION PROFILE POST LASIK. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 19816154 ↗
• InjuryJul 17, 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 HAD BLURRY VISION. THE IOL WAS EXCHANGED FOR UNSPECIFIED ATIOL LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS REFRACTIVE SURPRISE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 19759516 ↗
• InjuryJul 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT REASON AS IOL POSITION CHANGED AND CLINICAL REASON FOR EXPLANT BEING NOT SATISFIED WITH POSITION OF LENS, LENS REPOSITIONED POST INITIAL SURGERY. THE IOL WAS EXPLANTED AND EXCHANGED FOR A NON COMPANY LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. SYMPTOMS RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19752023 ↗
• InjuryMay 24, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED DISTANCE VISION. THE LENS WAS EXCHANGED 3 MONTHS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS DECENTERED IOL.ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THERE WAS NO PATIENT HARM REPORTED. IN THE SURGEON¿S OPINION THE EVENT MAY CAUSED BY POOR CAPSULE INTEGRITY.

  Patient problems: Blurred Vision

  MAUDE report 19390538 ↗
• InjuryMar 8, 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 WAS DISSATISFIED WITH DISTANCE AND FARE NEGATIVE DYSPHOTOPSIA. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL FOUR MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 18866938 ↗
• MalfunctionDec 29, 2023Defective Device; Defective Device

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS FOUND TO BE DAMAGED AND HENCE THE LENS WAS NOT IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 18417449 ↗
• MalfunctionNov 27, 2023Scratched Material; Scratched Material

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS SCRATCHED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18208097 ↗
• InjurySep 25, 2023Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR VISION. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 2 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS BROKEN HAPTIC AND LENS SUBLUXATION.ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 17806273 ↗
• InjuryAug 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, ON (B)(6) 2023 THE PATIENT WENT FOR CLEAR LENS EVALUATION AND COMPLAINED OF BLURRED VISION IN BOTH EYES. ON (B)(6) 2023 POST OPERATIVE VISIT PATIENT HAD NOTICED FOREIGN BODY SENSATION , MICROCYSTIC EDEMA AND PHOTOPHOBIA. ON (B)(6) 2023 THE PATIENT NOTICED BLURRED VISION, FLASHES, SHADOW, FOREIGN BODY SENSATION, PERIPHERAL IN AFFECTED EYE. ON (B)(6) 2023 VISIT OBSERVED NOTICED BLURRED VISION AND PHOTOPHOBIA. ON (B)(6) 0.2MM TEMP PLUGS POST LASIK. THE PATIENT COMPLAINTS THAT EYES FELT TIRED. ON (B)(6) 2023 NOTICED IRRITATION IN EYE , TEARING, LIGHT SENSITIVITY AND BLURRY VISION GIVEN TREATMENT WITH LOTEMAX. ON (B)(6) 2023 PATIENT HAD DRY EYES AND POSTERIOR CAPSULAR OPACIFICATION. ON (B)(6)2023 THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL ONE MONTH FOLLOWING THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS RESIDUAL ASTIGMATISM. AFTER SURGERY PATIENT ABLE TO DO ALL WORK WITHOUT GLASSES. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Corneal Edema; Discomfort; Dry Eye(s); Excessive Tear Production; Eye Pain; Flashers; Foreign Body Sensation in Eye; Visual Disturbances; Vitreous Floaters

  MAUDE report 17451571 ↗
• InjuryFeb 1, 2023Adverse 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 (IOL) IMPLANT PROCEDURE THE PATIENT EXPERIENCED BLURRED AND WASN¿T CORRECTABLE TO BE BETTER THAN 20/30. THE PATIENT HAD A CONSTANT BLUR AT ALL DISTANCES. IT WAS REPORTED THAT PATIENT RETURNED TO FACILITY FOR AN IOL EXCHANGE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT IOL WAS EXCHANGED WITH A NON COMPANY IOL. THE PATIENT'S ISSUES HAS BEEN IMPROVED. THE SURGEON¿S PROGNOSIS WAS GOOD.

  Patient problems: Blurred Vision

  MAUDE report 16275765 ↗
• InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING PATIENT'S SYMPTOMS WERE RESOLVED. THERE WAS NO PATIENT HARM AND PATIENT WAS NOT HOSPITALIZED AS A RESULT OF THIS EVENT.

  Patient problems: Visual Impairment

  MAUDE report 16128711 ↗
• MalfunctionDec 13, 2022Crack; Crack

  A FACILITY REPRESENTATIVE REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE LENS WAS CRACKED AND LENS WAS REMOVED ANS REPLACED WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED PATIENT DETAILS.

  Patient problems: Insufficient Information

  MAUDE report 15966703 ↗