Clareon CCWTT0 (UDI 00380652413602)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00380652413602), received between Aug 29, 2023 and May 26, 2026 — classified as 17 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2026Optical Decentration

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED BLURRY VISION AND CONSTANT HEADACHE. CLINICAL REASON FOR EXPLANT WAS LENS DID NOT CENTER WELL DESPITE PLACEMENT IN THE BAG. THE IOL WAS EXCHANGED FOR MONOFOCAL LENS 2 YEARS, 3 MONTHS DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT IN SURGEON OPINION THE LENS ITSELF DID NOT CONTRIBUTE TO PERCEIVED DECENTRATION; THE LENS OPTICS THEMSELVES ULTIMATELY CONTRIBUTED TO THE EVENT (THE DIFFRACTIVE OPTICS JUST DIDN¿T WORK WELL IN THIS EYE SUBJECTIVELY - THEY WORKED SURPRISINGLY WELL IN THE OTHER EYE).

  Patient problems: Blurred Vision; Headache

  MAUDE report 25280317 ↗
• MalfunctionFeb 3, 2026Scratched Material

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED, IN THE SURGEON OPINION IT WAS UNSURE IF THE LENS CAME SCRATCHED OR IF IT HAPPENED DURING THE LOADING PROCESS. THE LENS WAS EXPLANTED AND REPLACED WITH SIMILAR MODEL AND DIOPTER IN THE SAME PROCEDURE. THERE WAS NO PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 24246583 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFOMATION WAS RECEIVED STATING THAT, THE LENS WAS EXCHANGED AND THE PATIENT'S ISSUE RESOLVED.

  Patient problems: Visual Disturbances

  MAUDE report 24208775 ↗
• InjuryJan 2, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO PATIENT EXPERIENCED DOUBLE VISION AND MINOR STARBURST EFFECT AROUND LIGHTS. THE IOL WAS REPLACED WITH UNSPECIFIED LENS APPROXIMATELY WITHIN A MONTH AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Diplopia/Double Vision; Visual Disturbances

  MAUDE report 23947288 ↗
• MalfunctionDec 24, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS SHATTERED WHILE BEING IMPLANTED. IT WAS REMOVED, AND ANOTHER LENS WAS USED. ADDITIONAL INFORMATION WAS RECEIVED THERE WAS NO PATIENT HARM AND IN THE SURGEON¿S OPINION, POSSIBLY THE COMPANY INJECTOR WAS TAKEN OUT OF USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23887509 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REGISTERED NURSE REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION AT BOTH NEAR AND DISTANCE, ACCOMPANIED BY HEADACHES. THE LENS WAS REMOVED AND REPLACED WITH AN UNSPECIFIED MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL RATIONALE FOR EXPLANTATION WAS STATED AS MECHANICAL COMPLICATIONS OF THE IOL. BASED ON NEW INFORMATION PROVIDED, IN THE SURGEON'S OPINION, THE PRODUCT WAS RESPONSIBLE FOR THE PATIENT'S EVENTS. A NON-COMPANY LENS WAS USED AS REPLACEMENT. THERE WAS NO FURTHER IMPACT TO THE PATIENT.

  Patient problems: Blurred Vision; Headache

  MAUDE report 23423260 ↗
• InjurySep 8, 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 RESIDUAL MYOPIA. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS MODEL 1 MONTHS AND 5 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS RESIDUAL MYOPIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 22993758 ↗
• MalfunctionMay 27, 2025Failure to Advance; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL FOUND TO BE STUCK IN DELIVERY SYSTEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22087450 ↗
• 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 SAME DIOPTER POWER INDICATING THE CORRECT LENS POWER WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL.

  Patient problems: Visual Impairment

  MAUDE report 20695735 ↗
• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THE IOL WAS EXPLANTED AND EXCHANGED FOR A NON COMPANY LENS IN THE SECONDARY IMPLANT PROCEDURE. PATIENT HAD YAG (YTTRIUM ALUMINUM GARNET) PRIOR TO THE EXPLANT AND THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: Halo; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20688445 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED PATIENT OVERALL VISION WAS NOT AS GOOD AS BEFORE SURGERY. COULD NOT SEE ROADS OR TRAFFIC LIGHTS. THE PATIENT HAD MILD CORNEAL EDEMA WITH INCREASED GUTTATA NOTED ON 1 WEEK POST OPERATIVE EXAM. THERE WAS NO PATIENT HARM. THE IOL WAS EXCHANGED FOR ONE DIOPTER MORE POWER DIFFERENT MODEL COMPANY LENS. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL.

  Patient problems: Blurred Vision

  MAUDE report 20266117 ↗
• InjurySep 3, 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 HAD DISTANCE VISION BLURRY, BOTHERED BY NIGHT VISION, PAIN AND PRESSURE. THE IOL WAS EXCHANGED FOR NON-COMPANY LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Eye Pain; Intraocular Pressure Increased; Visual Impairment

  MAUDE report 20127207 ↗
• InjuryJul 22, 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 GLARE AT NIGHT WORSE THAN BEFORE SURGERY, CANNOT TOLERATE HALOS. THE IOL WAS EXCHANGED FOR ANOTHER COMPANY LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 19794119 ↗
• InjuryJun 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 POOR QUALITY VISION. THE CLINICAL REASON FOR EXPLANT WAS PATIENT WAS NOT ABLE TO IMPROVE VISION. THE LENS WAS EXPLANTED 6 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 19573340 ↗
• InjuryJun 10, 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) EXCHANGE PROCEDURE, THE PATIENT EXPERIENCED DECREASED VISION AND WAS FOUND TO HAVE POST OPERATIVE CORNEAL EDEMA. THE PATIENT WAS ON EYE DROPS MEDICATION THREE TIMES A DAY. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT PATIENT CORNEAL EDEMA WAS SLOWLY RESOLVING.

  Patient problems: Blurred Vision; Corneal Edema

  MAUDE report 19497377 ↗
• InjuryMay 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT EXPERIENCED THAT THE NEAR VISION WAS NOT GOOD. THE PATIENT COULD NOT SEE WELL AND WAS UNABLE TO DRIVE. THE IOL WAS REPLACED WITH A NON-COMPANY IOL IN A SECONDARY PROCEDURE. THE PATIENT COULD NOT TOLERATE THE LENS WAS STATED AS THE CLINICAL REASON FOR EXPLANT. ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED THE PATIENT WAS ALSO BOTHERED BY HALOS AND GLARE. THE PATIENT'S NEAR VISION WAS NOT GOOD AND THE DISTANCE VISION WAS OKAY. IN THE SURGEON'S OPINION THE QUALITY ISSUE WITH THE IOL CONTRIBUTED TO THE EVENTS. THE PATIENT HAD A HISTORY OF DRY EYE SYNDROME AND PUCKERING OF MACULA IN BOTH EYES. THE PATIENT'S ISSUES WERE RESOLVED AFTER REPLACEMENT WITH A NON-COMPANY LENS.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 19329921 ↗
• InjuryApr 19, 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 FLICKERING LIGHTS AND BLURRY VISION. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS NON-ADAPT FOR EDOF (EXTENDED DEPTH-OF-FOCUS). ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 19141863 ↗
• InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE PATIENT HAD SOME GLARE. THE SURGEON STATED THAT, THE PATIENT WAS GIVEN 1.0 D SCL TRIAL AND THE PATIENT CONFIRMED THAT THE VISION WAS CLEAR BUT THERE WAS STILL SOME HAZE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 18516624 ↗
• InjuryJan 1, 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 FEELS DIZZY. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 2 MONTHS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS INTOLERANCE OF COMPANY IOL MODEL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Dizziness

  MAUDE report 18423195 ↗
• InjuryAug 29, 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 STILL STRUGGLING TO SEE EVEN WITH CORRECTIVE GLASSES AND HAD CORRECTIVE LASER TREATMENT. THE OPHTHALMOLOGIST HAS CHECKED AND INSISTS THE PLACEMENT LOOKS RIGHT. THE PATIENT HAD ARTIFICIAL TEARS , FELT LIKE LIGHT WAS FLASHING FROM BEHIND AND HAD SHADOWS ALL AROUND. THE PATIENT WAS EXTREMELY FRUSTRATED BECAUSE THE PATIENT ALWAYS HAD GOOD NEAR VISION. ADDITIONAL INFORMATION HAS BEEN RECEIVED INCLUDES PATIENT'S NEAR AND MID VISION GOT WORSE AND EVERYTHING WAS STILL QUITE BLURRY AFTER SURGERY. DISTANCE IS GREATLY IMPROVED. AFTER MANY FOLLOW-UP VISITS WITH OPTOMETRIST THE PATIENT BOUGHT CORRECTIVE GLASSES FROM OPTOMETRIST WHICH HELPED SLIGHTLY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Flashers; Visual Disturbances

  MAUDE report 17641627 ↗