Clareon CCWTT0 (UDI 00380652413619)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00380652413619), received between Dec 12, 2022 and Aug 28, 2026 — classified as 12 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (2 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  A nurse reported that following an intraocular lens (IOL) implant procedure, the patient experienced blurry vision, chronic headaches and clinical reason for explant being struggle to neuroadapt. The IOL was explanted and exchanged for an unknown advanced technology intraocular lens following the initial implant procedure.Additional information has been requested but is not available at the time of this report.

  Patient problems: Blurred Vision; Headache

  MAUDE report 50498511 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD OTHER SUBJECTIVE VISUAL DISTURBANCES. THE IOL WAS EXCHANGED FOR NON-COMPANY LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.

  Patient problems: Visual Disturbances

  MAUDE report 25393406 ↗
• MalfunctionMar 2, 2026Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A SCRATCH WAS NOTICED ON THE LENS AFTER LOADING THE LENS IN THE PATIENT EYE. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY BY ANOTHER UNSPECIFIED LENS. IN THE SURGEON'S PROGNOSIS PATIENT CONDITION WAS GOOD AND ISSUES WAS RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24482836 ↗
• InjuryNov 10, 2025Adverse 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 VISION WAS NOT GOOD AT ALL DISTANCE. THIS MADE THE PATIENT LIFE AND WORK DIFFICULT. THE PHYSICIAN WAS PLANNED TO EXPLANT LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT IN-SURGEON OPINION LENS CAUSED OR CONTRIBUTED THE EVENT. PATIENT HAD SMALL PALPEBRAL FISSURE WITH HIGHER TEAR MENISCUS, WHICH WAS LESS TOLERABLE BY THE COMPANY LENS.

  Patient problems: Blurred Vision

  MAUDE report 23512362 ↗
• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING IN THE SURGEON'S OPINION, THE PRODUCT CAUSE OR CONTRIBUTE TO THE EVENT AND ORIGINAL LENS DID NOT FIX THE ASTIGMATISM.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision

  MAUDE report 22750257 ↗
• InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED IMMEDIATE AND PERSISTENT HAZY VISION, WHICH WAS AFFECTING HER ABILITY TO READ AND THE PATIENT WAS DEPENDING ON THE READING GLASS FOR IT. ADDITIONALLY, THE PATIENT HAD ALSO LOST CLARITY OF VISION IN COLOR AND SHARPNESS. THE PATIENT ALSO EXPERIENCED INFLAMMATION AT THE INCISION SITE FOR WHICH SHE WAS RECOMMENDED WITH THE STEROID FOR FOUR WEEKS AFTER SURGERY AND LATER IT WAS EXTENDED TO SIX WEEKS AFTER SURGERY BUT STILL THE INFLAMMATION PERSIST. THE PATIENT HAD ALSO EXPERIENCED ASTIGMATISM POST SURGERY.

  Patient problems: Blurred Vision; Inflammation; Visual Impairment

  MAUDE report 21545309 ↗
• MalfunctionFeb 18, 2025Failure to Deliver; Failure to Deliver

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON REPORTED THAT THE LENS WAS STUCK IN COMPANY CARTRIDGE AND HENCE THE LENS WAS IMPLANTED AND EXPLANTED. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY USING ANOTHER LENS. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION STATED THAT THE PATIENT SYMPTOMS WERE RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21399764 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING 2 WEEKS POST OP THE PATIENT EXPERIENCED BLURRED NEAR MID AND DISTANCE VISION. COMPANY LENS WAS EXCHANGED FOR A DIFFERENT DIOPTER SAME MODEL COMPANY LENS.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 20696335 ↗
• MalfunctionJul 11, 2024Particulates; Particulates

  A PHYSICIAN REPORTED THAT DURING SURGERY, THEY NOTICED THAT AN OBJECT EMBEDDED IN IOL MATERIAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19720620 ↗
• InjuryApr 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 EXPERIENCED HALOS. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL FOLLOWING THE INITIAL IMPLANT PROCEDURE DUE TO SEVERITY. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THE PATIENT DID NOT FEEL DRIVING SAFE AND PROGNOSIS WAS GOOD.

  Patient problems: Halo

  MAUDE report 19173211 ↗
• MalfunctionApr 4, 2024Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) HAD A SCRATCH THE ENTIRE LENGTH. VERY UNLIKELY A LOADING ERROR. PROCEDURE IS COMPLETED THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE ISSUE WITH COMPLAINT PRODUCT NOTICED AFTER IOL INSERTION. THERE WAS NO PATIENT HARM. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19040244 ↗
• InjuryFeb 12, 2024Adverse 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 HAD EXPERIENCED BLURRED VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS MODEL APPROXIMATELY TWO MONTHS AFTER INITIAL IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: Blurred Vision

  MAUDE report 18683882 ↗
• InjuryNov 3, 2023Adverse 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 HAD BLURRY VISION NEAR AND FAR. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 2 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT SYMPTOMS HAS BEEN RESOLVED AND THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision

  MAUDE report 18067148 ↗
• InjurySep 12, 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 EXPERIENCED HALOS AROUND EVERY LIGHT AND AT NIGHT FELT LIKE LIVING IN A NIGHTMARE. THE PATIENT WAS UNABLE TO DRIVE AT NIGHT. THE DOCTOR TOLD PATIENT THAT IF THE EYES HAD NOT IMPROVED BY THE TIME, THEY PROBABLY NEVER WOULD. PATIENT WAS UNHAPPY WITH THE OUTCOME. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED THAT PATIENT WAS PRESCRIBED EYE DROPS, AND THEN USED OVER THE COUNTER EYE DROPS FOR DRYNESS. THE DOCTOR GAVE SOME DROPS TO USE BEFORE GOING OUT AT NIGHT. BUT WAS NOT USED. THE PATIENT SAID THAT USUALLY USES TINTED GLASSES AT NIGHT AND EXPLORING CLEAR LENSES WITH A NON-GLARE COATING, BUT DIDN'T FIND ANY DIFFERENCE. HE ALSO STATED THAT THE LENSES WERE GREAT DURING THE DAY. AND HE DOESN'T NEED GLASSES FOR READING, SEWING OR ANY OTHER CLOSE WORK. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE (OS) FILE.

  Patient problems: Halo; Visual Impairment

  MAUDE report 17728887 ↗
• InjuryMay 4, 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 HAS RESIDUAL MYOPIA. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS LENS MALFUNCTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 16866821 ↗
• InjuryDec 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED BLURRED VISION, TOOK A SHOT IN THE EYE TO TREAT SWELLING AND HAD MACULAR EDEMA WITH THICKENING IN THE BACK OF THE EYE. HIS VISION WAS AROUND 20/60 UCVA, AND 20/30 BCVA AND THIS MIGHT IMPROVE WITH GLASSES. DUE TO THE THICKENING IN THE BACK OF THE EYE THE DOCTOR MIGHT CONSIDER THE OPTION OF A SURGERY. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THE MAIN CONCERN IS ABOUT THE LENS BEING OK AND AS SUCH CAN HAVE UNEXPECTED PROBLEMS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Macular Edema

  MAUDE report 15957159 ↗