Clareon CCWTT0 (UDI 00380652413633)Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00380652413633), received between Dec 5, 2022 and Sep 12, 2026 — classified as 27 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Visual Disturbances

  MAUDE report 50745344 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO PATIENT EXPERIENCED RINGS. THE CLINICAL REASON FOR EXPLANT WAS REPORTED TO BE PATIENT WAS UNHAPPY. THE IOL WAS REPLACED WITH LIGHT ADJUSTING LENS IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 24442695 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE LENS WAS EXCHANGED WITH COMPANY SIMILAL MODEL LENS BUT HALF DIOPTER LESS VALUE 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 24068795 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ADMINISTRATIVE ASSISTANT REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT EXPERIENCED BLURRED VISION. THE LENS WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH A NON-COMPANY LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON PROVIDED FOR THE EXPLANT WAS THAT THE PATIENT WAS UNABLE TO ADJUST TO THE IMPLANTED LENS. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 23692915 ↗
• InjuryNov 14, 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 BLURRY VISION. THE LENS WAS EXPLANTED AND REPLACED WITH OTHER COMPANY LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS PATIENT UNABLE TO ADJUST TO TORIC LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 23559780 ↗
• InjurySep 19, 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 VISUAL CHANGES AND WORSENED ACUITY. CLINICAL REASON BEING MENTIONED AS WORSE VISION. THE IOL WAS EXPLANTED AND EXCHANGED WITH AN UNSPECIFIED LENS IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, PATIENT FELT LIKE THERE WAS A CLOUDY FILM OVER EYES. THERE WAS NO FURTHER IMPACT TO THE PATIENT.

  Patient problems: Visual Impairment

  MAUDE report 23094881 ↗
• InjuryMay 27, 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, THE PATIENT EXPERIENCED DECREASED VISION, SIGNIFICANT GLARE, UNABLE TO DRIVE AT NIGHT AND CLINICAL REASON FOR EXPLANT BEING MECHANICAL COMPLICATION OF IOL. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL (ADVANCED TECHNOLOGY INTRAOCULAR LENS) FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 22086869 ↗
• InjuryMay 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN RECEIVED IT STATES THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision

  MAUDE report 22084660 ↗
• InjuryMay 8, 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, THE PATIENT HAD DYSPHOTOPSIA. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE ISSUE WAS OBSERVED IMMEDIATELY AFTER INITIAL SURGERY. PATIENT WAS UNHAPPY WITH DYSPHOTOPSIA. THE IOL WAS EXCHANGED FOR ANOTHER COMPANY LENS. THE PATIENT ISSUE WAS RESOLVED POST EXPLANT.

  Patient problems: Visual Disturbances

  MAUDE report 21985692 ↗
• InjuryApr 15, 2025Particulates; Device Dislodged or Dislocated; Particulates; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED, PATIENT EXPERIENCED FLOATERS AT 6 WEEKS AND GRADE 2 POSTERIOR CAPSULE OPACIFICATION (PCO) AT 3 MONTHS POST-OPERATIVE. IT WAS ALSO NOTICED THAT CARTRIDGE MATERIAL ADHERES TO POSTERIOR SURFACE OF LENS REQUIRING REMOVAL WITH IRRIGATION AND ASPIRATION THAT CAN SOMETIMES BE DIFFICULT. PATIENT ALSO HAD YTTRIUM ALUMINUM GARNET (YAG), LENS AND CAPSULE POLISH PROCEDURES POST-OPERATIVELY.

  Patient problems: Posterior Capsule Opacification; Vitreous Floaters

  MAUDE report 21843890 ↗
• InjuryApr 2, 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 VERY BOTHERED BY GLARED HALOS. THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) AFTER THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON WAS OTHER MECHANICAL COMPLICATION OF IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 21755885 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION STATED THAT IN THE SURGEON OPINION, THE PRODUCT CAUSE OR CONTRIBUTE TO THE EVENT. THE IOL WAS EXCHANGED FOR SAME DIOPTER NON COMPANY IOL WITH NO PATIENT HARM.

  Patient problems: Visual Disturbances

  MAUDE report 21675849 ↗
• InjuryDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED POSITIVE DYSPHOTOPSIA. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS UNABLE TO FUNCTION.

  Patient problems: Visual Disturbances

  MAUDE report 21025479 ↗
• InjuryNov 19, 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 MODEL COMPANY LENS INDICATING THE CORRECT LENS POWER WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 20720767 ↗
• MalfunctionOct 17, 2024Scratched Material; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE SCRATCH ON LENS WAS NOTICED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE LENS WAS NOTED TO HAVE A SCRATCH ON IT ONCE PLACED INTO THE EYE. IT WAS REMOVED AND REPLACED WITH ANOTHER LENS. NO PATIENT HARM WAS REPORTED. THE INCISION WAS NOT ENLARGED AND NO SUTURE WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 20469009 ↗
• InjurySep 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) IMPLANT PROCEDURE, THE PATIENT HAD MALADAPTATION. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS MODEL 2 MONTHS AND 24 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS MALADAPTATION. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20180563 ↗
• InjurySep 9, 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 MALADAPTATION. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS MODEL 3 MONTHS AND 3 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS MALADAPTATION. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20176608 ↗
• InjurySep 4, 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 MALADAPTATION. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS MODEL 04 MONTHS 04 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS MALADAPTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20133395 ↗
• InjuryAug 28, 2024Adverse 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 POOR ACUITY AND DYSPHOTOPSIA IN LEFT EYE. THE LENS WAS REMOVED AND REPLACED WITH A NON-COMPANY LENS IN A SECONDARY PROCEDURE.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 20083369 ↗
• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED, THE SURGERY WAS DONE IN PATIENT'S RIGHT EYE. THE IOL EXCHANGE WAS DONE WITH A COMPANY LENS OF SAME MODEL BUT DIFFERENT POWER. THE SYMPTOMS WERE RESOLVED AFTER LENS EXCHANGE.

  Patient problems: Blurred Vision

  MAUDE report 20076058 ↗
• InjuryAug 14, 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 WAS UNABLE TO ADAPT AND THE LENS WAS EXPLANTED. THERE WAS NO PATIENT HARM. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Visual Impairment

  MAUDE report 19979310 ↗
• InjuryAug 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION AT ALL DISTANCES AND DYSPHOTOPSIA. THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) 1 MONTH AND 23 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 19882860 ↗
• InjuryJul 8, 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 GLARE AND READING WAS VERY DIFFICULT. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS DYSPHOTOPSIAS SECONDARY TO IOL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 19690608 ↗
• MalfunctionApr 18, 2024Dent in Material; Dent in Material

  A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS ( IOL) HAD CREASE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19132051 ↗
• InjuryApr 1, 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 EXPERIENCED VISION IS HAZY NOTICEABLE WHILE DRIVING AND READING. THE IOL WAS EXCHANGED FOR ANOTHER NON-COMPANY LENS MODEL APPROXIMATELY 2 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT NO PATIENT HARM, SURGEON PROGNOSIS IS GOOD. THE PATIENT SYMPTOMS WERE RESOLVED.

  Patient problems: Visual Impairment

  MAUDE report 19011155 ↗