Clareon CCWTT0 (UDI 00380652413640)Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00380652413640), received between Aug 17, 2022 and Jun 5, 2026 — classified as 32 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (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 37 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2026Device Dislodged or Dislocated

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT EXPERIENCED BLURRED VISION. THE IOL HAS BEEN EXCHANGED IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS DISPLACEMENT IOL.

  Patient problems: Blurred Vision

  MAUDE report 25409473 ↗
• InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED AND REPORTED THAT THE IOL WAS EXCHANGED FOR THE DIFFERENT LENS MODEL BUT HALF A 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 Disturbances

  MAUDE report 24838969 ↗
• InjuryMar 23, 2026Device Dislodged or Dislocated

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS INSERTED IN THE CAPSULAR BAG WAS FINE THEN LENS STARTED TO ANGLE TOWARDS BACK OF THE EYE. THE VITRECTOMY WAS DONE AND LENS WAS EXPLANTED AND REPLACED DURING SAME PROCEDURE. IN SURGEON'S OPINION POSSIBLE BUR ON LENS, CAUSED OR CONTRIBUTED TO EVENT. THERE WERE NO PATIENT HARM AND PATIENT SYMPTOMS HAVE BEEN RESOLVED.

  Patient problems: Capsular Bag Tear

  MAUDE report 24663526 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COULD NOT ADAPT TO MULTIFOCAL. THE IOL WAS EXCHANGED FOR A NON-COMPANY, DIFFERENT DIOPTER LENS 06 MONTHS 09 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS THAT THE PATIENT COULD NOT ADAPT TO MULTIFOCAL.

  Patient problems: Visual Impairment

  MAUDE report 24003024 ↗
• MalfunctionOct 24, 2025Break; Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF BROKEN HAPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23376313 ↗
• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED POSITIVE DYSPHOTOPSIA. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER MONOFOCAL LENS IN A SECONDARY PROCEDURE.

  Patient problems: Visual Disturbances

  MAUDE report 22884968 ↗
• InjuryJul 1, 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 BLURRED VISION. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER NON COMPANY LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS MALADAPTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 22373384 ↗
• InjuryMay 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, HE EXPERIENCED SIGNIFICANT AND PERSISTENT VISION ISSUES THAT HAVE ADVERSELY AFFECTED THE DAILY LIFE. PRIOR TO THE SURGERY DISTANCE VISION WAS CLEAR AND HAD NO MAJOR VISUAL DISTURBANCES. AFTER THE SURGERY HE EXPERIENCED PERSISTENT HALO EFFECT AROUND LIGHTS, WHICH WAS EXPECTED TO SUBSIDE WITHIN A FEW MONTHS BUT CONTINUES UNABATED, BLURRY DISTANCE VISION WHICH WAS A NEW ISSUE THAT DID NOT EXIST BEFORE THE SURGERY, FREQUENT FLASHES OF LIGHT, FLOATERS AND A GENERAL SENSE OF VISUAL INSTABILITY, RAPID EYE FATIGUE, MAKING ROUTINE TASKS CHALLENGING, SIGNIFICANT DIFFICULTIES WITH BOTH DAYTIME AND NIGHTTIME DRIVING DUE TO LIGHT REFLECTIONS AND HALO EFFECTS AND BLURRINESS, TROUBLE SEEING WHICH WAS HIGH IN SUN FILLED SITUATIONS SUCH AS VERY BRIGHT SUNNY DAYS, SNOW AND BEACH REFLECTIONS. HIS VISION HAS BECOME WORST AND HAD NOT SEEN ANY IMPROVEMENT AT ALL SINCE THE SURGERY. HE CONSULTED WITH DOCTOR AT LEAST FOUR OR FIVE OCCASIONS POST SURGERY, EXPRESSING THESE CONCERNS EACH TIME. WHILE HE WAS INFORMED ABOUT THE POSSIBILITY OF A TEMPORARY HALO EFFECT, THE DURATION AND SEVERITY OF HIS SYMPTOMS HAVE FA

  Patient problems: Blurred Vision; Dizziness; Visual Disturbances; Visual Impairment; Vitreous Floaters

  MAUDE report 21982408 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT HAD HOPED THE LENS MIGHT HAVE BEEN THE SOURCE OF THE ONGOING ISSUES THEY WERE EXPERIENCING. IT WAS ALSO STATED THAT THE PATIENT'S VISION HAD BEEN DETERIORATING SINCE THE LENSES WERE IMPLANTED.

  Patient problems: Blurred Vision; Dizziness; Visual Disturbances; Visual Impairment; Vitreous Floaters

  MAUDE report 21960684 ↗
• InjuryApr 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 THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT EXPERIENCED POOR VISION. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. CLINICAL REASON MENTIONED AS "BCVA 20/40 AND GLARE.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 21772976 ↗
• InjuryMar 26, 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 HALOS, SHADOWS. CLINICAL REASON BEING MENTIONED AS MECHANICAL COMPLICATION OF INTRAOCULAR LENS (IOL). THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN MONOFOCAL INTRAOCULAR LENS IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THE IOL WAS EXCHANGED FOR NON-COMPANY LENS IN THE SECONDARY IMPLANT PROCEDURE AND THERE WAS NO PATIENT IMPACT.

  Patient problems: Visual Disturbances

  MAUDE report 21694843 ↗
• InjuryMar 21, 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 CLOUDY AND HAZY VISION. CLINICAL REASON BEING MENTIONED AS MECHANICAL DEFECT OF IOL. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL (ADVANCED TECHNOLOGY INTRAOCULAR LENS) IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 21663775 ↗
• InjuryMar 21, 2025Adverse 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, PATIENT EXPERIENCED BLURRY VISION AND WAS NOT ABLE TO DRIVE AT NIGHT. THE LENS WAS EXCHANGED FOR ANOTHER LENS 3 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 21662859 ↗
• InjuryFeb 24, 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 POOR QUALITY OF VISION, CLINICAL REASON FOR EXPLANT WAS MECHANICAL COMPLICATION OF IOL. THE IOL WAS REPLACED FOR WITH UNSPECIFIED MONOFOCAL IOL MODEL LENS 6 MONTHS 5 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 21446447 ↗
• InjuryJan 6, 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 HAD NOT BEEN ABLE TO ADAPT TO THE LEFT EYE HALOS FROM THE COMPANY LENS. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 05 MONTHS 17 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo

  MAUDE report 21079205 ↗
• InjuryOct 15, 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 EXPERIENCED BLURRY VISION AT ALL DISTANCES. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 7 MONTHS AND 10 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE PATIENT EXPERIENCED HYPEROPIC MISS. NO PATIENT HARM WAS REPORTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 20451677 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT AFTER SURGERY, THE PATIENT HAD MALADAPTATION. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER UNSPECIFIED LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20178532 ↗
• 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 9 MONTHS AND 8 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 20176663 ↗
• 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 06 MONTHS 20 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 20139673 ↗
• 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 2 MONTHS AND 23 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 20136578 ↗
• InjuryAug 5, 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 VISUAL INTOLERANCE. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 19904479 ↗
• MalfunctionJul 30, 2024Appropriate Device Problem Term/Code Not Available; Failure to Eject; Appropriate Device Problem Term/Code Not Available; Failure to Eject

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PLUNGER SLIPPED UNDER LENS WHEN INJECTING INTO EYE . THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED LENS WAS IMPLANTED AND EXPLANTED IN INITIAL PROCEDURE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19863431 ↗
• InjuryMay 27, 2024Adverse 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 WITH POOR VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 21 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT PATIENT WAS NOT TOLERATING THE LENS, PATIENT ISSUES WERE RESOLVED AFTER IOL EXCHANGE AND THERE WAS NO PATIENT HARM.

  Patient problems: Visual Impairment

  MAUDE report 19400477 ↗
• MalfunctionMay 8, 2024Scratched Material; Scratched Material

  A PHYSICIAN REPORTED WITH A DESCRIPTION OF SMALL SCRATCH ON POSTERIOR PART OF INTRAOCULAR LENS (IOL). THEY FOLLOWED ALL THE USUAL INSTRUCTIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE LENS WAS NOT EXPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 19268167 ↗
• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT VISION IS NOT CLEAR WITH TROUBLE FOCUSING ESPECIALLY CLOSEUP. ADDITIONAL INFORMATION HAS BEEN RECEIVED, STATING THAT THE PATIENT EXPERIENCED LIGHT HALOS AFTER SURGERY. THE PATIENT UNDERWENT YAG CAPSULOTOMY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Halo

  MAUDE report 19088462 ↗