Clareon CCWTT0 (UDI 00380652413671)Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00380652413671), received between Sep 2, 2022 and Jun 8, 2026 — classified as 43 injuries, 7 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. 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 50 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2026Product Quality Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 02 YEARS 01 MONTH FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS UNSPECIFIED ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 25427219 ↗
• InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED A PLANNED EXPLANT WITH PATIENT EXPERIENCING GLARE, BLURRY VISION AND HALOS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE PATIENT COULD SEE THE LINES ON THE VISION TEST WHEN WE CHECKED HIM FOR BOTH DISTANCE AND NEAR BUT KEPT SAYING EVERYTHING SEEMS BLURRY AND THERE WAS GLARE EVEN THOUGH HIS VISION TESTED AT 20/20. THE LENS HAD BEEN EXCHANGED FOR A NON COMPANY LENS IN A SECONDARY PROCEDURE. THE MULTIFOCAL LENS CAUSED GLARE AND HALOS THAT THE PATIENT WAS UNABLE TO NEUROADAPTIVE TO SO YES, PATIENT WAS AWARE OF THESE RISKS. THERE WAS NO FURTHER IMPACT TO THE PATIENT. SURGEONS PROGNOSIS WAS NOTED TO BE GREAT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 25125076 ↗
• InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT EXPERIENCED BLURRY VISION. THE IOL HAD BEEN EXCHANGED IN A SECONDARY PROCEDURE.

  Patient problems: Blurred Vision

  MAUDE report 25125064 ↗
• MalfunctionApr 30, 2026Break

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, BACK HAPTIC BROKE OFF WHILE IMPLANTING IN THE PATIENT. SUBSEQUENTLY THE LENS WAS CUT OUT DURING INITIAL PROCEDURE AND REPLACED WITH ANOTHER LENS. THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25045488 ↗
• 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 REASON AND CLINICAL REASON WERE MENTIONED AS INABILITY TO ADAPT TO MULTIFOCAL. THE IOL WAS EXPLANTED AND EXCHANGED WITH AN UNSPECIFIED MONOFOCAL LENS DURING THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THERE WAS NO FURTHER IMPACT TO THE PATIENT.

  Patient problems: Visual Impairment

  MAUDE report 24004451 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL)IMPLANTATION SURGERY, THE PATIENT EXPERIENCED GLARE, HALOS, BLURRINESS AND DISTORTION AND WAS EXPERIENCING IT SEVERE AND OCCURS IN DAYLIGHT, NIGHTTIME, INDOORS AND OUTDOORS. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE PATIENT EXPERIENCED, SEVERE AND CONSTANT GLARE, BLURRING, HALOS, STARBURST IN ALL LIGHTING CONDITIONS- DAYTIME, NIGHTTIME, INDOORS, OUTDOORS. NOTHING WAS IN FOCUS AND THE PATIENT COULD NOT SEE ANYONE¿S FACE CLEARLY UNTIL THEY ARE WITHIN ABOUT 5 FEET FROM ME. THESE SYMPTOMS GOT PROGRESSIVELY WORSE WITHIN A WEEK AFTER THE SURGERY. THE PATIENT ALSO PURCHASED GLASSES FOR USE WITH THE LAPTOP BUT THERE WAS MINIMAL IMPROVEMENT. THE PATIENT ALSO WORE SUNGLASSES AT ALL TIMES OUTSIDE, SUNNY OR OVERCAST. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO RIGHT EYE.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 23885853 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL)IMPLANTATION SURGERY, THE PATIENT EXPERIENCED GLARE, HALOS, BLURRINESS AND DISTORTION AND WAS EXPERIENCING IT SEVERE AND OCCURS IN DAYLIGHT, NIGHTTIME, INDOORS AND OUTDOORS. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE PATIENT EXPERIENCED, SEVERE AND CONSTANT GLARE, BLURRING, HALOS, STARBURST IN ALL LIGHTING CONDITIONS- DAYTIME, NIGHTTIME, INDOORS, OUTDOORS. NOTHING WAS IN FOCUS AND THE PATIENT COULD NOT SEE ANYONE¿S FACE CLEARLY UNTIL THEY ARE WITHIN ABOUT 5 FEET FROM ME. THESE SYMPTOMS GOT PROGRESSIVELY WORSE WITHIN A WEEK AFTER THE SURGERY. THE PATIENT ALSO PURCHASED GLASSES FOR USE WITH THE LAPTOP BUT THERE WAS MINIMAL IMPROVEMENT. THE PATIENT ALSO WORE SUNGLASSES AT ALL TIMES OUTSIDE, SUNNY OR OVERCAST.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 23850382 ↗
• InjuryDec 4, 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 BLURRY VISION, VISUAL DISTURBANCE AND CONSTANT FOREIGN BODY SENSATION AND THE PATIENT WAS UNHAPPY WITH THE VISION. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS MENTIONED AS CAN'T TOLERATE VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 23714598 ↗
• InjuryDec 2, 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 UNCLEAR VISION. CLINICAL REASON FOR EXPLANT MYOPIC SURPRISE. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) MODEL COMPANY LENS 03 MONTHS 13 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 23701004 ↗
• MalfunctionNov 26, 2025Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS WAS SCRATCHED. THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION WAS RECEIVED AS THE LENS WAS IMPLANTED AND SUBSEQUENTLY EXPLANTED DURING THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23654989 ↗
• InjuryNov 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, HAVING TROUBLE SEEING AT NIGHT, WHITE AND YELLOW LINES ON HIGHWAY APPEARED DOUBLED- NOTHING ELSE, NOT THE CARS OR BUILDINGS. PATIENT CONSULTED THE PHYSICIAN, AND PHYSICIAN SAID IT SEEMS TO BE AN EYE MUSCLE PROBLEM. PHYSICIAN RECOMMENDED EYEGLASSES WITH A PRISM CORRECTION. ALSO STATED WHEN THE PATIENT WENT OUT DURING NIGHT TIME TO CHECK SHORTER DISTANCE WAS NOT CLEAR MULTIPLE TIMES.

  Patient problems: Blurred Vision

  MAUDE report 23628518 ↗
• InjurySep 10, 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 GLARE AND FLICKERING LIGHTS BOTHERSOME. THE IOL WAS EXCHANGED FOR UNSPECIFIED ADVANCED TECHNOLOGY INTRAOCULAR LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS DID NOT TOLERATE HALOS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE LENS WAS EXCHANGED FOR ANOTHER MODEL COMPANY LENS. THERE WAS NO PATIENT HARM.

  Patient problems: Visual Disturbances

  MAUDE report 23015999 ↗
• InjurySep 5, 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 COULD NOT GET USED TO REFRACTION. THE IOL HAD BEEN EXPLANTED IN A SECONDARY PROCEDURE. CLINICAL REASON FOR THE EXPLANT WAS MENTIONED IOL FAILURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 22978577 ↗
• InjuryAug 28, 2025Adverse 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 CANNOT SEE CLEARLY. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 02 MONTHS 16 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS DIPLOPIA, ANISOMETROPIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Diplopia/Double Vision; Visual Disturbances

  MAUDE report 22911151 ↗
• 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 BLURRY VISION AND STATED EVERYTHING WAS BLURRY SINCE SURGERY. CLINICAL REASON BEING MENTIONED VISUAL DISTURBANCES AND MECHANICAL COMPLICATION. YAG PROCEDURE WAS COMPLETED. THE PATIENTS CONDITION WAS REPORTED AS UNDETERMINED AND STILL WAITING ON LDD TREATMENTS. THE SURGEON'S 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 22588376 ↗
• InjuryJul 23, 2025Optical Decentration; Optical Decentration

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR QUALITY VISUAL ACUITY AND GLARE. THE IOL WAS EXCHANGED FOR ANOTHER MODEL 1 DIOPTER MORE COMPANY LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS HALO, GLARE, LENS DECENTRATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 22574472 ↗
• InjuryApr 24, 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 WAS BOTHERED BY RINGS. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS RINGS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 21900287 ↗
• InjuryFeb 18, 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 BLURRY VISION. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS MODEL 1 MONTHS AND 12 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS IOL CAME TOO STRONG. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 3 OF 3. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 21394040 ↗
• InjuryFeb 6, 2025Adverse 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 WITH POOR VISUAL ACUITY NEAR AND FAR LIGHT SENSITIVITY. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 01 MONTH 18 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS POOR VISUAL ACUITY NEAR AND FAR LIGHT SENSITIVITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 21322428 ↗
• InjuryOct 26, 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 THINGS ARE FUZZY. CLINICAL REASON FOR EXPLANT WAS MALADAPTATION TO RINGS. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) MODEL LENS 5 MONTHS 8 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20540220 ↗
• InjuryOct 25, 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 THINGS ARE FUZZY. CLINICAL REASON FOR EXPLANT WAS MALADAPTATION TO RINGS. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) MODEL LENS 5 MONTHS 8 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20535375 ↗
• InjuryOct 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 EXPERIENCED HALOS AND STARBURST SO BAD UNABLE TO NIGHT DRIVE AND DIFFICULTY WITH DAYLIGHT DRIVING IN SUN. CLINICAL REASON FOR EXPLANT WAS REPORTED AS HALOS AND STARBURST SO BAD UNABLE TO NIGHT DRIVE AND DIFFICULTY WITH DAYLIGHT DRIVING IN SUN. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS MODEL 1 MONTH 29 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 20407421 ↗
• InjurySep 27, 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 VISION WAS NOT CLEAR AND HAD HALOS. PATIENT WAS NON-ADAPTED WITH COMPANY LENS AND PRESENTED HALOS. THE IOL WAS EXCHANGED FOR ANOTHER COMPANY LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS DYSPHOTOPSIA. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 20322968 ↗
• InjurySep 12, 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 LIMITATIONS IN VISION (OS). THE IOL WAS EXCHANGED FOR NON-COMPANY LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 20198527 ↗
• 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 1 MONTH AND 11 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 20178605 ↗