Clareon CCWTT0 (UDI 00380652413664)Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00380652413664), received between Nov 16, 2022 and Aug 28, 2026 — classified as 39 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (6 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 49 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 halos and eye fatigue after implantation. The IOL was explanted in the secondary implant procedure.Additional information has been requested and received by stating there was no further impact to the patient.There are two medical reports associated with this patient. This is for left eye.

  Patient problems: Visual Disturbances

  MAUDE report 50495777 ↗
• InjuryMay 5, 2026Adverse 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 AT NIGHT. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 05 MONTHS 17 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS STARBURSTS AND HALOS.

  Patient problems: Visual Disturbances

  MAUDE report 25082740 ↗
• InjuryApr 15, 2026Adverse 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 BLURRED VISION AND GLARE. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 06 MONTHS 06 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS BLURRED VISION. 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 RIGHT EYE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24884701 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED FLUTTER IN THE CORNER OF EYE WITH SUDDEN MOVEMENTS, EPISODES OF CLOUDY VISION, WHICH PHYSICIAN ATTRIBUTED TO FLOATERS. THE PATIENT ALSO NOTED HALOS AT NIGHT WHILE DRIVING, ESPECIALLY WITH ONCOMING HEADLIGHTS. THESE HALOS ARE LESS SEVERE COMPARED TO PRE-SURGERY BUT REMAIN BOTHERSOME. ADDITIONAL INFORMATION WAS RECEIVED PATIENT WAS HAPPY WITH THE VISION, FLUTTERING IS STILL PRESENT. PATIENT WAS SEEKING TO CONTACT HIS SURGEON TO PROVIDE DETAILS ON SYMPTOMS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Eye Irritation; Visual Disturbances; Visual Impairment; Vitreous Floaters

  MAUDE report 24222569 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED FLUTTER IN THE CORNER OF EYE WITH SUDDEN MOVEMENTS, EPISODES OF CLOUDY VISION, WHICH PHYSICIAN ATTRIBUTED TO FLOATERS. THE PATIENT ALSO NOTED HALOS AT NIGHT WHILE DRIVING, ESPECIALLY WITH ONCOMING HEADLIGHTS. THESE HALOS ARE LESS SEVERE COMPARED TO PRE-SURGERY BUT REMAIN BOTHERSOME. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE PATIENT WAS HAPPY WITH VISION BUT WANTED TO KNOW IF THE FLUTTERING IN CORNER WAS NORMAL.

  Patient problems: Eye Irritation; Visual Disturbances; Visual Impairment; Vitreous Floaters

  MAUDE report 24147240 ↗
• 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. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision

  MAUDE report 23628530 ↗
• MalfunctionNov 21, 2025Device Difficult to Setup or Prepare; Device Damaged by Another Device; Device Difficult to Setup or Prepare; Device Damaged by Another Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, LENS LOADING DIFFICULTIES WAS OBSERVED AND THE LENS WAS SCRATCHED IN THE DELIVERY SYSTEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23617761 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED AN EXPLANTED IOL WITH PATIENT REASON AS VISION WAS BLURRY DISTANCE AND NEAR. CLINICAL REASON BEING PATIENT UNABLE TO ADAPT TO TECHNOLOGY. THE IOL WAS EXPLANTED AND EXCHANGED FOR A NON-COMPANY LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THERE WAS NO FURTHER IMPACT TO THE PATIENT. DISTANCE VA WAS GOOD, UNABLE TO READ WAS REPORTED. PATIENT WOULD NEED READING GLASSES. SYMPTOMS WERE CONTINUING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 23290122 ↗
• InjuryAug 1, 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) IMPLANTATION PROCEDURE, THE PATIENT HAD EXPERIENCED BLURRY VISION. THE CLINICAL REASON PROVIDED WAS A MECHANICAL COMPLICATION OF THE IOL. THE IOL HAD BEEN REPLACED WITH A NON-COMPANY MONOFOCAL IOL THREE MONTHS AFTER THE INITIAL IMPLANT PROCEDURE WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 22686340 ↗
• InjuryJul 4, 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, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO PATIENT EXPERIENCED HALOS, GLARE. THE CLINICAL REASON FOR EXPLANT WAS REPORTED TO BE DIFFRACTIVE IOL. THE IOL WAS REPLACED WITH UNSPECIFIED MONOFOCAL LENS APPROXIMATELY ELEVEN MONTHS AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 22403654 ↗
• InjuryMay 6, 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 WAS HAVING SO MUCH DIFFICULTY, COULD NOT DRIVE AND STATED THAT HAD TO USE BLUE LIGHT GLASSES TO READ, HAD SHADOW IN THE PERIPHERY AND EYE WAS SENSITIVE TO LIGHT, THE PATIENT BOTH EYES WERE FIGHTING WITH EACH OTHER, IT WAS ALSO STATED THAT THE PATIENT WAS EXPERIENCING HALOS, LETTERS BECAME BLURRY AND USED TEARS TO TRY AND CLEAR VISION.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21966490 ↗
• InjuryMar 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED LIKE LOOKING THROUGH A PLASTIC SHEET. THE LENS WAS THEN EXCHANGED WITH UNKNOWN MONOFOCAL IOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANTATION WAS MECHANICAL COMPLICATION, PUPIL WAS OFF CENTER THUS IOL WAS OFF CENTER. ADDITIONAL INFORMATION RECEIVED STATING THAT THERE WAS PUPIL IRREGULARITY. THE LENS WAS THEN EXCHANGED WITH COMPANY DIFFERENT MODEL AND DIFFERENT DIOPTER. IN THE SURGEONS OPINION PRODUCT CONTRIBUTED TO EVENT.

  Patient problems: Blurred Vision

  MAUDE report 21716025 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION, TERRIBLE HALOS, DECREASED DISTANCE VISION. THE IOL WAS EXCHANGED FOR ANOTHER COMPANY LENS 1 YEAR 3 MONTHS 4 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Headache; Visual Disturbances

  MAUDE report 21639586 ↗
• InjuryMar 14, 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, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO PATIENT EXPERIENCED DECREASED NEAR VISION, GLARE DISTANCE VISION 20/25. THE IOL WAS REPLACED WITH OTHER COMPANY LENS APPROXIMATELY FOUR MONTHS AFTER INITIAL PROCEDURE. PATIENT SYMPTOMS WERE RESOLVED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21606668 ↗
• MalfunctionMar 14, 2025Product Quality Problem; Scratched Material; Product Quality Problem; Scratched Material

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, LOADING TECHNICIAN OBSERVED SMALL BUBBLE ON OPTIC BUT ASSUMED IT WAS A BUBBLE IN THE VISCOELASTIC, THEN IT WAS LOADED INTO THE CARTRIDGE AND INSERTED TO THE EYE. UPON INTRAOCULAR LENS (IOL) INSERTION, A SCRATCH WAS OBSERVED IN THE CENTER OF OPTIC. PROCEDURE COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS RECEIVED AND IT STATES THAT IT WAS CONFIRMED TO BE A DEFECT ON THE LENS THAT DID NOT MOVE WITH THE INSERTION OF THE LENS OR LENS MANIPULATION. LENS WAS INSERTED INTO PATIENT'S EYE, DEFECT WAS OBSERVED, IMPLANT WAS DISSECTED AND REMOVED DURING INITIAL PROCEDURE, REPLACED IMMEDIATELY. IN THE SURGEON¿S OPINION, LENS DEFECT WAS OF UNKNOWN ORIGIN FROM EITHER MANUFACTURING OR SHIPPING AND HANDLING. BEFORE IMPLANTING TECH STATES THAT SHE LOADED THE IMPLANT DURING IRRIGATION AND ASPIRATION (IA) PHASE, WHICH MEANS IT WOULD HAVE BEEN IN THE CARTRIDGE FOR 5 MINUTES OR LESS. PATIENT PROGNOSIS WAS GOOD. CLEAR PSEUDOPHAKIC VISION WAS ACHIEVED AND HEALING AS EXPECTED POST OPERATION 1 WEEK. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21606190 ↗
• MalfunctionFeb 26, 2025Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SCRATCH WAS OBSERVED AFTER THE LENS WAS INJECTED INTO THE EYE. LENS WAS EXPLANTED IN INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER IOL ON THE SAME DAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21467818 ↗
• MalfunctionFeb 24, 2025Break; Break

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT AFTER THE SURGEON HAD IMPLANTED THE LENS, SHE NOTICED THAT THERE WAS A PIECE OF THE HAPTIC MISSING. THE LENS WAS REMOVED DURING INITIAL PROCEDURE. THE SURGERY WAS COMPLETED THE SAME DAY USING ANOTHER COMPANY LENS. NO HARM TO THE PATIENT. THE WOUND WAS NOT ENLARGED AND NO SUTURE WAS NEEDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21444775 ↗
• InjuryFeb 10, 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 SAID VISION WAS NOT CLEAR. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 04 MONTHS 25 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS FAILURE TO ADAPT OR MECHANICAL. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT WAS NOT HAPPY WITH VA DISTANCE AND NEAR. THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 21344050 ↗
• MalfunctionNov 21, 2024Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING SURGERY, THEY NOTICED THAT, LENS HAD SCRATCH ONCE IMPLANTED, WAS REMOVED FROM PATIENT EYE. NO PATIENT INJURY. SURGERY WAS COMPLETED USING BACKUP COMPANY LENS OF SAME MODEL AND DIOPTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20747860 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD BLURRY VISION AND MYOPIA. THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 20503371 ↗
• InjuryOct 11, 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 HALOS AND SHADOWS. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 04 MONTHS 27 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS MECHANICAL COMPLICATION. ADDITIONAL INFORMATION WAS RECEIVED, THERE WAS NO PATIENT HARM.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 20425566 ↗
• MalfunctionSep 13, 2024Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DAMAGED DURING INSERTION, SCRATCH ON THE LENS FROM LOADING WITH PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20211988 ↗
• 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 LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20178579 ↗
• 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 UNSPECIFIED ATIOL VIVITY LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20178530 ↗
• 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 5 MONTHS AND 2 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS MALADAPTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 20136691 ↗