Clareon CCWET3 (UDI 00380652455275)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00380652455275), received between Apr 4, 2023 and Dec 14, 2025 — classified as 17 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryDec 14, 2025Adverse 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 WAS NOT HAPPY WITH THE VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 01 MONTH 20 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS PATIENT UNHAPPY WITH THE CURRENT LEVEL OF VISUAL ACUITY.ADDITIONAL INFORMATION RECEIVED AND STATED THAT THERE WAS NO FURTHER IMPACT TO THE PATIENT.IN THE SURGEON¿S OPINION, PRODUCT WAS CONTRIBUTED THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Visual Impairment

  MAUDE report 23799486 ↗
• MalfunctionNov 14, 2025Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE ISSUE OCCURRED DURING LOADING WITH NO PATIENT CONTACT.

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

  MAUDE report 23552954 ↗
• InjuryOct 27, 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 IMPLANT PROCEDURE, THE PATIENT HAD POWER SURPRISE, AND THE LENS WAS EXPLANTED AND EXCHANGED 6 MONTHS FOLLOWING THE INITIAL PROCEDURE WITH UNSPECIFIED ATIOL LENS. THE REASON FOR EXPLANT WAS MENTIONED AS BLURRY VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 23392320 ↗
• InjurySep 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 EXPERIENCED BLURRY DISTANCE VISION. CLINICAL REASON FOR EXPLANT WAS MILD MYOPIC REFRACTIVE ERROR. THE IOL WAS EXCHANGED FOR ANOTHER UNSPECIFIED ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) 50 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 23092842 ↗
• InjurySep 2, 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 BLURRY DAY VISION. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS MODEL 1 MONTH AND 5 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS RESIDUAL ASTIGMATISM. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE PATIENT CAN'T READ STREET SIGNS OR CAN'T SEE HER PHONE. THE PATIENT ISSUES WERE RESOLVED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 22936209 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THE PATIENT CAME INTO THE CLINIC AND WAS HAPPY WITH HIS VISION. HE DEFERRED THE IOL EXCHANGE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22860168 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT THE PATIENT UNDERWENT LASIK BUT DOES NOT KNOW HIS PRE-LASIK (LASER-ASSISTED IN SITU KERATOMILEUSIS) MEASUREMENTS. BASED ON RESULTS PHYSICIAN RECOMMENDED A COMPANY LENS AND IT WAS IMPLANTED. AFTER SURGERY, 10-0 WAS PUT IN THE MAIN WOUND AS IT WAS LEAKY. POW (POST OPERATIVE WEEK) 1 YIELDS CRISP VISION 20/20 WITH MINIMAL CORNEAL EDEMA, TORIC MARKERS ALIGNED, THEN THE 10-0 NYLON WAS REMOVED FROM MAIN WOUND AT 45 DEGREES. POW2 YIELDS CRISP 20/20. NO CLINICAL CORNEAL EDEMA SEEN, TORIC MARKERS ALIGNED. POW3 PATIENT BEING SEEN TO ASSESS FOR STABILITY OF MRX (REFRACTION). ADDITIONALLY PATIENT EXPERIENCED ASTIGMATIC REFRACTIVE SURPRISE. SURGEON THOUGHT THAT THE RESIDUAL REFRACTIVE ERROR IS FROM POSTERIOR CORNEAL ASTIGMATISM FOR THAT THEY DON'T HAVE THE TECHNOLOGY TO MEASURE. SO, THE PATIENT WAS DISSATISFIED WITH VISION AND INTERESTED IN IOL (INTRAOCULAR LENS) EXCHANGE, WHICH SURGEON INCLINED TO OFFER WITHIN THE NEXT FEW WEEKS. ADDITIONAL INFORMATION HAS RECEIVED AND IT STATES THAT THERE WAS NO IMPACT TO THE PATIENT AND LIKELY PLANNING FOR IOL EXCHANGE. ADDITIONAL INFORMATION HAS RECEIVED AND IT STATES THAT THE PATIENT EXPERIENCED BLURRY VISION. CLINICAL REASON BEING

  Patient problems: Blurred Vision; Corneal Edema; Visual Disturbances; Visual Impairment; Wound Dehiscence

  MAUDE report 22002947 ↗
• InjuryJan 6, 2025Optical Decentration; Optical Decentration

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WITH BLURRED DISTANCE VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 08 MONTHS 09 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS DECENTERED POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 21079303 ↗
• InjuryAug 21, 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 POOR NEAR VISION. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS PATIENT WANTING IMPROVED NEAR VISION. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 2. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 20012036 ↗
• InjuryJun 10, 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 NOT SATISFIED WITH VISION. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 19497467 ↗
• InjuryJun 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION AND THE SURGEON NOTED THE LENS TO BE ROTATED 20-25 DEGREES OFF AXIS. SURGEON SENT THE PATIENT FOR 2ND OPINION WITHIN HIS OFFICE, AND THAT DOCTOR WAS NOT FAMILIAR WITH VIVITY TORIC LENSES. SHE SOUGHT OUT HER OWN 2ND OPINION AND THAT SURGEON DID NOT WANT TO DO LENS ROTATION, BUT PHOTOREFRACTIVE KERATECTOMY INSTEAD. HE DID A TRIAL CONTACT LENS TOLERABILITY ON HER AND IT DID IMPROVE HER VISION. PATIENT HAS HX OF LASIK MANY YEARS AGO. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 19466554 ↗
• InjuryMay 30, 2024Adverse 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 STILL HAVING A FEELING LIKE HAVING A SENSATION OF SOMETHING IN THE EYE. PATIENT CANNOT SEE IN LOW LIGHTING AND HAVE TO HAVE REALLY BRIGHT LIGHT TO READ. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Foreign Body Sensation in Eye; Visual Impairment

  MAUDE report 19423741 ↗
• InjuryFeb 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED. EXPLANT WAS DUE, TO ANISOMETROPIA AND ANISEIKONIA.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 18804822 ↗
• InjuryFeb 27, 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 PATIENT EXPERIENCED OBSCURED VISION.THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL SIX MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 18787454 ↗
• InjuryNov 27, 2023Adverse 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. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 6 MONTHS 21 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 18208598 ↗
• InjuryJun 20, 2023Malposition of Device; Malposition of Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT EXPERIENCED BLURRY VISION AT DISTANCE. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. CLINICAL REASON IS IMPLANT ROTATION FROM INITIAL LOCATION CAUSING FARSIGHTEDNESS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. HOWEVER NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 17163765 ↗
• InjuryMay 8, 2023Defective Device; Defective Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED RESIDUAL MYOPIA. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS LENS MALFUNCTION. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 16884138 ↗
• InjuryApr 4, 2023Adverse 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 DISTURBANCE LIKE HALOS STREAK IN LIGHT. THE CLINICAL REASON FOR EXPLANT MENTIONED AS PATIENT CANNOT TOLERATE VISUAL DISTURBANCES EVEN WITH REFRACTIVE CORRECTION. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 5 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 16675298 ↗