Clareon CCWTT0 (UDI 00380652413695)Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00380652413695), received between Dec 12, 2022 and Sep 11, 2026 — classified as 42 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Crack” (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 52 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 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 poor vision. The IOL was exchanged for unspecified monofocal lens. Clinical reason for explant was mentioned as other mechanical complications of IOL.Additional information has been requested, received and stated the IOL was exchanged for another company lens. There was no further patient impact.

  Patient problems: Blurred Vision

  MAUDE report 50734469 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER IMPLANTATION OF INTRAOCULAR LENS, THE PATIENT HAD BLURRY VISION. THE LENS WAS EXPLANTED AND REPLACED WITH UNSPECIFIED ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) IN SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS REPORTED TO BE MYOPIC SURPRISE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS IS 1 OF 2. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 25137116 ↗
• MalfunctionMar 30, 2026Scratched Material

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANT PROCEDURE, AFTER PLACING LENS, IT WAS DETERMINED TO BE SCRATCHED AND NEEDED TO BE REMOVED. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT. THE PATIENT'S ISSUES WERE RESOLVED AND THE SURGEON'S PROGNOSIS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24729996 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  UPON FURTHER REVIEW OF AVAILABLE INFORMATION, 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

  MAUDE report 24577633 ↗
• InjuryFeb 21, 2026Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION IN THE RIGHT EYE, THE PATIENT EXPERIENCED POOR VISION, DESCRIBED AS FILM OVER THE EYE, ALONG WITH HEADACHES AND A FOREIGN BODY SENSATION. THE LENS WAS SUBSEQUENTLY REMOVED AND REPLACED WITH AN ANTERIOR CHAMBER INTRAOCULAR LENS (ATIOL) IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS LARGE MYOPIC SHIFT AFTER IMPLANTATION AND MECHANICAL COMPLICATION OF THE IOL. BASED ON ADDITIONAL INFORMATION RECEIVED ON 03-FEB-2026: THE PATIENT COULD NOT SEE WELL AFTER ORIGINAL IMPLANTATION PROCEDURE. THE SURGEON CONFIRMED THAT THE IOL ITSELF DID NOT CONTRIBUTE TO THE EVENTS; INSTEAD, THE REFRACTIVE SURPRISE WAS DUE TO PATIENT'S PRIOR REFRACTIVE SURGERIES. THE IOL EXCHANGE WAS PERFORMED USING THE SAME MODEL LENS FROM THE COMPANY, BUT WITH A LOWER POWER (SIX DIOPTERS LESS THAN THE ORIGINAL). THE PATIENT'S SYMPTOMS WERE RESOLVED, AND THE SURGEON REPORTED A GOOD PROGNOSIS. THERE WAS NO FURTHER IMPACT TO THE PATIENT.

  Patient problems: Blurred Vision; Foreign Body Sensation in Eye; Headache; Visual Impairment

  MAUDE report 24408645 ↗
• MalfunctionFeb 3, 2026Failure to Deliver

  A NON-HEALTHCARE PROFESSIONAL REPORTED AN ISSUE THAT OCCURRED DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION CONDUCTED VIA PHACOEMULSIFICATION. THE IOL BECAME STUCK IN THE DELIVERY DEVICE AND COULD NOT BE ADVANCED INTO THE EYE. IT WAS PARTIALLY INSERTED INTO THE INCISION BEFORE BEING REMOVED. THE LENS WAS THEN REPLACED WITH ANOTHER LENS FROM THE SAME COMPANY, WITH THE SAME MODEL AND DIOPTER, DURING THE INITIAL PROCEDURE. THE PATIENT OUTCOME WAS GOOD. THE SURGERY WAS PERFORMED IN PATIENT'S LEFT EYE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245415 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  A NONHEALTH CARE PROFESSIONAL REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LENS CAME TOO STRONG. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS BLURRY VISION, AND THE LENS CAME TOO STRONG.

  Patient problems: Blurred Vision

  MAUDE report 24208783 ↗
• MalfunctionDec 5, 2025Product Quality Problem; Product Quality Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER THE LENS WAS INSERTED, THE DOCTOR SAW BUBBLES INSIDE THE LENS MATERIAL AND CUT OUT THE LENS DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED THE SAME DAY USING A REPLACEMENT LENS, WHICH WENT FINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23728323 ↗
• InjuryNov 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT REASON AS DISTORTED VISION AND CLINICAL REASON FOR EXPLANT BEING DISPLACEMENT OF LENS. 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 EXPERIENCED BLURRY VISION. THERE WAS NO FURTHER IMPACT TO THE PATIENT. SYMPTOMS WERE RESOLVED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 23671895 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS NOT EXPERIENCED FULL CLARITY OR CONTRAST AT DISTANCE. THE IOL WAS EXPLANTED AND EXCHANGED WITH AN UNSPECIFIED MONOFOCAL LENS IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 23461705 ↗
• InjurySep 19, 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 (IOL) IMPLANTATION, THE PATIENT EXPERIENCED BLURRY VISION, HALOS AND GLARE. THE LENS WAS REMOVED AND REPLACED WITH A NON-COMPANY LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS DYSPHOTOPSIA. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 23097503 ↗
• InjurySep 4, 2025Adverse 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 HALOS AND GLARE. THE LENS WAS EXPLANTED AND REPLACED WITH OTHER COMPANY LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS DYSPHOTOPSIA. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 22962631 ↗
• InjuryAug 12, 2025Adverse 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 BLURRED UNCORRECTED ACUITY. THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR THE EXPLANT WAS PREVIOUS LASIK ENHANCEMENT AND POST OPERATIVE MYOPIA WAS GREATER THAN TARGET REFRACTION. ADDITIONAL INFORMATION RECEIVED STATING THAT IN THE SURGEON'S OPINION PREVIOUS LASIK ENHANCEMENT CONTRIBUTED TO EVENT.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 22783459 ↗
• InjuryAug 5, 2025Adverse 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 SAME COMPANY LENS WITH DIFFERENT 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: Halo

  MAUDE report 22714846 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BCVA REDUCED AND VISUAL DISTURBANCES AND STATED EVERYTHING WAS BLURRY SINCE SURGERY. CLINICAL REASON BEING MENTIONED BLURRED VISION. YAG PROCEDURE WAS COMPLETED. THE PATIENTS CONDITION WAS REPORTED AS UNDETERMINED AND STILL WAITING ON LDD TREATMENTS. THE SURGEONS PROGNOSIS REPORTED AS GOOD POSTOPERATIVE APPEARANCE. THE IOL WAS EXPLANTED AND EXCHANGED WITH AN NON COMPANY LENS IN THE SECONDARY IMPLANT PROCEDURE. THERE WAS NO FURTHER IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22588381 ↗
• InjuryJul 12, 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 IOL WAS EXPLANTED IN A SECONDARY PROCEDURE DUE TO UNSPECIFIED ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22488702 ↗
• InjuryMay 30, 2025Product Quality Problem; Device Dislodged or Dislocated; Product Quality Problem; Device Dislodged or Dislocated

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS MENTIONED THAT EVERYTHING WAS BLURRY. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS LENS WAS DISLOCATED THEN DISCOVERED LENS HAD DEFECT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE LENS WAS REMOVED AND REPLACED WITH SAME MODEL AND DIOPTER COMPANY LENS. THE PATIENT ISSUE WAS RESOLVED AND SURGEON PROGNOSIS FOR PATIENT WAS GOOD.

  Patient problems: Blurred Vision

  MAUDE report 22113927 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL DURING REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS HAVING TOO MUCH GLARE AND HALOS. CLINICAL REASON IS PATIENT WAS EXPERIENCING DYSPHOTOPSIA. THE IOL WAS EXCHANGED FOR NON COMPANY INTRAOCULAR LENS 2 MONTHS, 1 WEEK FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE PATIENTS ISSUES WERE RESOLVED. IN SURGEON OPINION PRODUCT CAUSED THE EVENT. SURGEONS PROGNOSIS PENDING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 22034703 ↗
• InjuryMay 12, 2025Product Quality Problem; Product Quality Problem

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION. THE LENS WAS EXPLANTED AND REPLACED WITH OTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS IOL CAME TOO STRONG. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 22001592 ↗
• InjuryMay 5, 2025Adverse 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 SAME LENS MODEL BUT 5.5 DIOPTER MORE 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 21959455 ↗
• MalfunctionApr 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS DISLOCATED INTO ANTERIOR VITREOUS. SECONDARY EXPLANT WAS PLANNED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21917178 ↗
• InjuryApr 1, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM CONSUMER VIA CALL STATING THAT THE IOL WAS EXCHANGED FOR ANOTHER MODEL DIFFERENT DIOPTER FROM SAME COMPANY LENS, 2 YEARS 10 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21742983 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED LIGHT SENSITIVITY, DECREASED NEAR VISION, GLARE. CLINICAL REASON BEING MENTIONED AS MECHANICAL COMPLICATION DEFECT OF LENS IN RIGHT EYE (OD) CAUSING DIMINISHING VISION AND GLARE. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL (ADVANCED TECHNOLOGY INTRAOCULAR LENS) IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS RECEIVED AND IT STATES THAT THERE WAS NO PATIENT IMPACT WAS REPORTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21525394 ↗
• MalfunctionFeb 26, 2025Break; Failure to Fold; Break; Failure to Fold

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS BROKEN. ADDITIONAL INFORMATION RECEIVED STATING THAT LENS FOLDED DURING INSERTION AND HAPTIC BROKE. THE LENS WAS NOT INSERTED, CARTRIDGE WAS PARTIALLY INSERTED THEN INSERTION PROCESS WAS IMMEDIATELY ABORTED. THE PROCEDURE WAS COMPLETED ON SAME DAY BY USING UNSPECIFIED REPLACEMENT IOL. THERE WAS NO PATIENT HARM. IN THE SURGEON¿S OPINION, LOADING OR FOLDING THE LENS CONTRIBUTED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21469839 ↗
• MalfunctionFeb 26, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A CRACK IN THE OPTIC OF THE IOL. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH UNSPECIFIED REPLACEMENT IOL. ADDITIONAL INFORMATION RECEIVED STATING THAT IN THE SURGEON¿S OPINION, UNSURE IF IT WAS LOADING ISSUE OR PRODUCT ISSUE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21468860 ↗