Clareon CCWTT0 (UDI 00380652413596)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00380652413596), received between Oct 27, 2022 and Feb 13, 2026 — classified as 17 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2026Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS LODGED. THE PROCEDURE WAS COMPLETED WITH UNSPECIFIED LENS. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24331321 ↗
• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT IN THE SURGEON'S OPINION, THE PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THE TRIFOCAL LENS WAS EXCHANGED WITH COMPANY MONOFOCAL INTRAOCULAR LENS WITH SAME DIOPTER VALUE AFTER THE INITIAL IMPLANT PROCEDURE. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL.

  Patient problems: Visual Impairment

  MAUDE report 23905858 ↗
• MalfunctionAug 6, 2025Break; Break

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE HAPTIC BROKE OFF INSIDE THE CARTRIDGE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22726889 ↗
• MalfunctionMay 30, 2025Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED SCRATCH OR MARK ON OPTIC. LENS CUTTER USED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH ANOTHER IOL. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22116371 ↗
• InjuryMay 13, 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, THE PATIENT STRUGGLES TO READ AND WITH VISION OVERALL. THE LENS WAS EXPLANTED AND EXCHANGED 4 MONTHS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS MECHANICAL COMPLICATION OF IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 22008791 ↗
• InjuryApr 1, 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 INTOLERABLE NIGHT TIME STAR-BURSTING/HALOS. CLINICAL REASON BEING MENTIONED AS DYSPHOTOPSIA. 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: Visual Disturbances

  MAUDE report 21737871 ↗
• InjuryNov 8, 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 POOR VISION AND BOTH SHARPNESS GLARE, HALOS. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 01 MONTHS 05 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS POOR TOLERANCE OF MULTIFOCAL WITH KNOWN REPORTED ADVERSE EFFECTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 20641953 ↗
• InjuryOct 11, 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 POOR VISION, AND EYE PAIN. THE IOL WAS EXCHANGED FOR NON-COMPANY MONOFOCAL MODEL LENS 01 MONTH 03 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING, DISTANCE VISION AND NIGHT VISION WAS BLURRY. PAIN AND PRESSURE ARE MAIN COMPLAINTS. IN THE SURGEON'S OPINION THE PRODUCT DID NOT CONTRIBUTE OR CAUSE PAIN AND PRESSURE BUT CONTRIBUTED OR CAUSED BLURRY VISION AND NIGHT VISION. THE IOL WAS EXCHANGED FOR NON-COMPANY MONOFOCAL MODEL LENS 01 YEAR 1 MONTH 03 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE PATIENT¿S ISSUES WERE RESOLVED. THE SURGEON¿S PROGNOSIS WAS GOOD. NO PATIENT HARM.

  Patient problems: Blurred Vision; Eye Pain; Intraocular Pressure Increased; Visual Impairment

  MAUDE report 20425567 ↗
• 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 ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) MODEL 01 MONTHS 05 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 20134824 ↗
• InjuryAug 28, 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 NOT HAPPY WITH VISION AT ANY DISTANCE. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. CLINICAL REASON FOR EXPLANT, MENTIONED AS VISION DISTORTION. THIS REPORT IS ASSOCIATED WITH MULTIPLE COMPLAINTS. THIS FILE IS 2 OF 2. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 20083402 ↗
• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS VERY UNHAPPY WITH THE QUALITY OF VISION. THE SURGEON THOUGHT THAT IT WAS DUE TO THE NATURE OF HAVING A DIFFRACTIVE MULTIFOCAL INTRAOCULAR LENS. THE IOL WAS EXCHANGED FOR A LIGHT ADJUSTABLE LENS (LAL) MODEL DURING A SECONDARY PROCEDURE. FROM POST OPERATIVE DAY 1 THE PATIENT WAS HAPPIER EVEN BEFORE SURGEON DID ANY ADJUSTMENTS. AS PER SURGEON THIS WAS ONE OF THE RARE PATIENTS WHO JUST COULD NOT ADJUST TO A MULTIFOCAL. AT THE END OF THE DAY, THE PATIENT WAS VERY HAPPY WITH LAL LENS IN BOTH EYES (OU).

  Patient problems: Visual Impairment

  MAUDE report 20074893 ↗
• InjuryAug 21, 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 VISION WAS WORSE THAN BEFORE SURGERY, CAN'T HARDLY SEE THE CAR IN FRONT OF HIM. CLINICAL REASON BEING MENTIONED AS MULTIFOCAL INTOLERANCE. ADDITIONAL INFORMATION HAVE BEEN RECEIVED IT STATES THAT THE IOL WAS EXPLANTED AND EXCHANGED WITH ANOTHER COMPANY LENS FOLLOWING THE SECONDARY IMPLANT PROCEDURE.

  Patient problems: Blurred Vision

  MAUDE report 20014022 ↗
• InjuryJun 21, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DECREASED VISION. CLINICAL REASON FOR EXPLANT WAS SUNSET IOL. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) MODEL 1 MONTHS 5 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING NO HARM TO THE PATIENT AND PATIENT'S ISSUES WERE RESOLVED.

  Patient problems: Blurred Vision

  MAUDE report 19582790 ↗
• InjuryApr 16, 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 VISION IS WORSE THAN BEFORE SURGERY ESPECIALLY READING. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT PATIENT EXPERIENCED VISON IS BLURRY AT ALL DISTANCES, HALOS AND TROUBLE READING. THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision; Halo; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19114138 ↗
• 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 LEFT EYE.

  Patient problems: Blurred Vision; Halo

  MAUDE report 19087407 ↗
• InjuryJan 8, 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, PATIENT WAS NOT HAPPY WITH VISION. CLINICAL REASON WAS MENTIONED AS HALOS INTOLERABLE. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 7 MONTHS 24 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Impairment

  MAUDE report 18463093 ↗
• InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED A POOR VISUAL OUTCOME AFTER CATARACT SURGERY ABOUT A PATIENT 3 WEEKS POST OPERATIVE. SHE CANNOT READ PRINT, TEXT, OR SMALLER STREET SIGNS. HER INTERMITTENT VISION WAS OK. SHE USED TO BE ABLE TO SEE THE EDGE OF LEAVES AND SHARP IN THE DISTANCE WITHOUT EFFORT. NOW EVERYTHING WAS A STRUGGLE. SHE WAS AFRAID TO HAVE THE LEFT EYE DONE BECAUSE SHE WOULD NOT BE ABLE TO FUNCTION. SURGEON HAD SAID THAT LIKELY PRIOR ORTHO-K TREATMENT 20 YEARS AGO MAY HAVE TO DO WITH THE OUTCOME. SHE RECALLED HER EYE WAS DRY AND IRRITATED ON PRE-OP MEASUREMENTS. SHE THINKS THE DOCTOR PICKED THE WRONG LENS. HER VISION WAS 20/20 DISTANCE WITHOUT CORRECTION, HER INTERMEDIATE WAS 20/40 AND HER NEAR WAS 20/63 WITHOUT CORRECTION. HER REFRACTION WAS PLANO. SURGEONS PROGNOSIS WAS ABOUT 1/3 WILL ADAPT AND THE OTHERS CAN EXCHANGE THE IOL WITH GOOD OUTCOME. SHE WAS WAITING ANOTHER MONTH. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT HER SYMPTOMS CONTINUE AND SHE STILL THINKS THE SURGEON HAS IMPLANTED WRONG LENS. SHE HAS DECIDED TO HAVE 2ND OPINION.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 17938871 ↗
• InjurySep 26, 2023Adverse 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 HALOS AND FUZZY VISION. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS DYSPHOTOPSIA AND FUZZY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 17818379 ↗
• InjuryAug 29, 2023Adverse 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 STILL STRUGGLING TO SEE EVEN WITH CORRECTIVE GLASSES AND HAD CORRECTIVE LASER TREATMENT. THE OPHTHALMOLOGIST HAS CHECKED AND INSISTS THE PLACEMENT LOOKS RIGHT. THE PATIENT HAD ARTIFICIAL TEARS , FELT LIKE LIGHT WAS FLASHING FROM BEHIND AND HAD SHADOWS ALL AROUND. THE PATIENT WAS EXTREMELY FRUSTRATED BECAUSE THE PATIENT ALWAYS HAD GOOD NEAR VISION. ADDITIONAL INFORMATION HAS BEEN RECEIVED INCLUDES PATIENT'S NEAR AND MID VISION GOT WORSE AND EVERYTHING WAS STILL QUITE BLURRY AFTER SURGERY. DISTANCE IS GREATLY IMPROVED. AFTER MANY FOLLOW-UP VISITS WITH OPTOMETRIST THE PATIENT BOUGHT CORRECTIVE GLASSES FROM OPTOMETRIST WHICH HELPED SLIGHTLY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision; Flashers; Visual Disturbances

  MAUDE report 17642310 ↗
• MalfunctionFeb 15, 2023Crack; Scratched Material; Crack; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON IMPLANTED LENS THEN IT WAS FOUND TO BE SCRATCHED/CRACKED AND THEN IT WAS REMOVED. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16380602 ↗
• InjuryOct 27, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A MATERIAL MANAGER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DISTORTED AND BLURRED VISION. THE CLINICAL REASON WAS DECENTERED POSTERIOR CAPSULE INTRA OCULAR LENS. THE INTRA OCULAR LENS WAS EXPLANTED AND EXCHANGED FOR ATIOL (ADVANCED TECHNOLOGY INTRAOCULAR LENS) LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 15680074 ↗