Clareon CCWTT0 (UDI 00380652413626)Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00380652413626), received between Sep 8, 2022 and Apr 8, 2026 — classified as 33 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT THE PATIENT SAW HER EYE DOCTOR A FEW DAYS AFTER SURGERY DUE TO INFLAMMATION, BLURRED AND POOR VISION, EYE PAIN, DISCOMFORT, SWELLING, EDEMA, AND HAS BEEN TREATED MANY TIMES SINCE THEN FOR THE SAME ISSUES. SHE WAS TREATED FOR SEVERE DRY EYES WITH NON PRESERVATIVE DROPS, WARM COMPRESSES, AND AMP. IT FELT LIKE SHE HAD SOMETHING IN HER EYES THAT WAS NOT SUPPOSED TO BE THERE, WHICH WAS CONFIRMED BY THE DOCTOR. ADDITIONALLY, UPON FURTHER FOLLOW UP PATIENT ALSO HAD NUCLEAR SCLEROSIS, POSTERIOR VITREOUS DETACHMENT, ACUTE IRITIS, SECONDARY NONINFECTIOUS IRIDOCYCLITIS, CYSTOID MACULAR EDEMA, HIGH MYOPIA AND UNDERWENT CAM360 AMNIO GRAFT RECENTLY, AND IT HELPED A LITTLE BUT DID NOT LAST. TODAY, THE PATIENT REPORTED THAT SHE HAD AN IRRITATION, BLURRED VISION, BURNING, WATERING OR TEARING, ITCHING, AMP, PAIN IN HER EYES WITH HEADACHE WITH THE SLIGHTEST MOVEMENT OF HER HEAD. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO RIGHT EYE.

  Patient problems: Blurred Vision; Corneal Edema; Dry Eye(s); Eye Irritation; Eye Pain; Macular Edema; Uveitis; Visual Impairment; Vitreous Detachment

  MAUDE report 24816439 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT THE PATIENT SAW HER EYE DOCTOR A FEW DAYS AFTER SURGERY DUE TO INFLAMMATION, BLURRED AND POOR VISION, EYE PAIN, DISCOMFORT, SWELLING, EDEMA, AND HAS BEEN TREATED MANY TIMES SINCE THEN FOR THE SAME ISSUES. SHE WAS TREATED FOR SEVERE DRY EYES WITH NON PRESERVATIVE DROPS, WARM COMPRESSES, AND AMP. IT FELT LIKE SHE HAD SOMETHING IN HER EYES THAT WAS NOT SUPPOSED TO BE THERE, WHICH WAS CONFIRMED BY THE DOCTOR. ADDITIONALLY, UPON FURTHER FOLLOW UP PATIENT ALSO HAD OCULAR HYPERTENSION, NUCLEAR SCLEROSIS, POSTERIOR VITREOUS DETACHMENT, ACUTE IRITIS, SECONDARY NONINFECTIOUS IRIDOCYCLITIS, CYSTOID MACULAR EDEMA, HIGH MYOPIA, EPIRETINAL MEMBRANE AND UNDERWENT CAM360 AMNIO GRAFT RECENTLY, AND IT HELPED A LITTLE BUT DID NOT LAST. TODAY, THE PATIENT REPORTED THAT SHE HAD AN IRRITATION, BLURRED VISION, BURNING, WATERING OR TEARING, ITCHING, AMP, PAIN IN HER EYES WITH HEADACHE WITH THE SLIGHTEST MOVEMENT OF HER HEAD. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO LEFT EYE.

  Patient problems: Blurred Vision; Corneal Edema; Dry Eye(s); Eye Irritation; Eye Pain; Intraocular Pressure Increased; Macular Edema; Uveitis; Visual Impairment; Vitreous Detachment

  MAUDE report 24581171 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, FIRST DAY AFTER SURGERY, THE PATIENT DESCRIBED THEIR VISION WAS LOOKING LIKE THROUGH A SMUDGE OF VASELINE IN BOTH EYES. SO, THE PATIENT HAD LASER SURGERY. ADDITIONALLY, THE PATIENT UNDERWENT MANY NEURO STUDIES AND SCAN SHOWED NEGATIVE RESULTS (DID NOT HAVE OCCIPITAL GLIOMA OR EYE RELATED MULTIPLE SCLEROSIS). FURTHERMORE, ALL EYE EXAMINATION SHOWED NORMAL RESULTS AND THERE WAS NO EYE PAIN, BUT NOTHING WAS CLEAR. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO LEFT EYE.

  Patient problems: Blurred Vision

  MAUDE report 24470364 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WITH BLURRED VISION, GLARE AND HALOS THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 02 MONTHS 11 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS MECHANICAL COMPLICATION OF IOL. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE LENS WAS EXCHANGED WITH NON-COMPANY LENS WITH A DIFFERENT DIOPTER.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24019497 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED AND REPORTED THAT THE IOL WAS EXCHANGED FOR THE SAME 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 Impairment

  MAUDE report 23959669 ↗
• InjuryOct 17, 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) THE PATIENT WAS UNHAPPY WITH VISION. THE IOL HAS BEEN EXCHANGED IN A SECONDARY PROCEDURE. CLINICAL REASON MENTIONED AS INCORRECT IOL POWER, PATIENT DOESN'T LIKE MULTIFOCAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Impairment

  MAUDE report 23324090 ↗
• InjuryOct 17, 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 THE LENS WAS EXCHANGED WITH COMPANY ANOTHER MODEL LENS WITH DIOPTER VALUE 18. 5 D. HALF A DIOPTER LESS 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 Impairment

  MAUDE report 23323080 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION, PATIENT INTOLERANT OF HALOS/GLARE. THE LENS WAS EXCHANGED FOR AN UNKNOWN MONOFOCAL LENS AFTER THE INITIAL IMPLANT PROCEDURE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE IS 1 OF 2.

  Patient problems: Visual Disturbances

  MAUDE report 22554869 ↗
• InjuryJun 5, 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 WITH BLURRED VISION. THE LENS WAS EXCHANGED FOR OTHER LENS MODEL 14 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS PATIENT NEEDED LIMBAL RELAXING INCISIONS (LRI) FOR ASTIGMATISM. ADDITIONAL INFORMATION WAS RECEIVED, THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 22150937 ↗
• InjuryMar 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 VISUAL DISTURBANCES. THE IOL WAS EXCHANGED FOR MONOFOCAL LENS MODEL 9 MONTHS AND 1 DAY AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS DYSPHOTOPSIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 21677756 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WITH GLARE AND HALOS MAKE IT HARD TO SEE. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 02 MONTHS 15 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS PATIENT INTOLERANCE. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THERE WAS NO PATIENT IMPACT.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 21639556 ↗
• MalfunctionJan 16, 2025Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, FIRST LENS WAS EXPLANTED IN INITIAL PROCEDURE DUE TO SCRATCH ALONG POSTERIOR SIDE OF IOL. SECOND LENS HAD A TORN HAPTIC, EXPLANTED, AND THE THIRD ONE WAS SUCCESSFUL. THE PROCEDURE WAS COMPLETED WITH ANOTHER IOL. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS REPORT IS ABOUT SCRATCH ALONG POSTERIOR SIDE OF IOL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21167477 ↗
• MalfunctionJan 15, 2025Break; Break

  A PHYSICIAN REPORTED THAT DURING SURGERY THE LENS HAD A TORN HAPTIC AND EXPLANTED DURING INITIAL PROCEDURE AND SURGERY WAS COMPLETED BY USING ANOTHER UNSPECIFIED LENS. ADDITIONAL INFORMATION HAS RECEIVED AND IT STATES THAT NO PATIENT IMPACT WAS REPORTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS REPORT IS ABOUT TORN / SHEARED TRAILING HAPTIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21157097 ↗
• InjuryJan 3, 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 DYSPHOTOPSIA. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS WAXY VISION DU TO LASIK. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THE PATIENT WAS UNHAPPY WITH THE VISUAL OUTCOME AND FEELS THE QUALITY OF VISION IS SMUDGED. THE SURGEON'S PROGNOSIS IS, THE ISSUE OCCURRED DUE TO IMPLANTATION OF WRONG TYPE OF LENS DUE TO LASIK HISTORY. THE PATIENT'S ISSUE HAS BEEN RESOLVED AND THERE IS NO PATIENT HARM.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21066196 ↗
• InjuryDec 27, 2024Optical Decentration; Device Difficult to Setup or Prepare; Defective Component; Optical Decentration; Device Difficult to Setup or Prepare; Defective Component

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE PATIENT SAW ARCS OF LIGHT DUE TO DECENTERED INTRA OCULAR LENS. IN SURGEON'S OPINION, IMPROPER INTRA OCULAR LENS LOADING CAUSED OR CONTRIBUTED TO THE EVENT. THE PATIENT ISSUES WERE RESOLVED AND THE SURGEONS PROGNOSIS WAS GOOD.

  Patient problems: Diplopia/Double Vision

  MAUDE report 21025597 ↗
• InjuryDec 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 SUBJECTIVE VISUAL DISTURBANCE AND LOW CONTRAST. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 30 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS UNHAPPY WITH VISUAL, POOR COLORS AND CONTRAST. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT PATIENT UNABLE TO ADAPT TO MULTIFOCALITY. NO PATIENT HARM WAS REPORTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 20912715 ↗
• InjuryOct 24, 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, PATIENT HAD INTOLERABLE BLURRED VISION. THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) 3 MONTHS AND 27 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON WAS INTOLERABLE BLURRED VISION AND MECHANICAL COMPLICATION OF IOL. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 20520134 ↗
• InjuryAug 28, 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 GLARE BOTHERSOME. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 02 MONTHS 13 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS PATIENT DISSATISFACTION WITH IMPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 20083401 ↗
• InjuryAug 26, 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 EXPERIENCED UNKNOWN ISSUE. THE IOL WAS EXPLANTED AND EXCHANGED FOR A SAME MODEL AND A 17.5 DIOPTER COMPANY LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE EVEN WITH REFRACTION POST EXCHANGE THE PATIENT WAS VERY DISSATISFIED WITH THE QUALITY OF HIS VISION WHICH WAS DUE TO THE NATURE OF HAVING A DIFFRACTIVE MULTIFOCAL IOL . PERFORMED ANOTHER EXCHANGE AND PUT IN A LIGHT ADJUSTABLE LENS. FROM POST OPERATIVE DAY 1, THE PATIENT WAS HAPPIER EVEN BEFORE WE DID ANY ADJUSTMENTS. ALSO, THE PATIENT COULD NOT ADJUST TO A MULTIFOCAL.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 20063664 ↗
• InjuryAug 23, 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 NEAR VISION. THE LENS WAS EXCHANGED FOR AN UNKNOWN MONOFOCAL IOL 1 MONTH AND 25 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON WAS THE PATIENT UNHAPPY WITH THEIR VISUAL ACUITY. ADDITIONAL INFORMATION RECEIVED STATING THAT THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 20050741 ↗
• InjuryJun 11, 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 BLURRY VISION IN EYE AT A DISTANCE. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS NOT ADAPT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 19515139 ↗
• MalfunctionMay 13, 2024Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED SCRATCH ON LENS, THERE WAS PATIENT CONTACT. THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND REPLACED WITH OTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19296513 ↗
• 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 UNHAPPY WITH VISION AT A DISTANCE. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THERE WAS NO PATIENT HARM.

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

  MAUDE report 19114197 ↗
• InjuryFeb 29, 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 EXPERIENCED CHRONIC HEADACHE AND MID RANGE VISION WAS UNCLEAR. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 5 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Headache

  MAUDE report 18810677 ↗
• InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MATERIALS MANAGER REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, PATIENT EXPERIENCED BLURRED VISION AT ALL DISTANCES. THE PATIENT WAS DISSATISFIED WITH VISION. THE LENS WAS REMOVED AND REPLACED WITH A MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS VISUAL DISTURBANCE. ADDITIONAL INFORMATION WAS RECEIVED. IN THE SURGEON'S OPINION THE IOL CONTRIBUTED TO PATIENT'S SYMPTOMS. THE PATIENT SEEMED NOT TO TOLERATE MULTIFOCALITY. THE IOL EXCHANGE WAS DONE WITH A NON-COMPANY LENS. THERE WAS NO HARM REPORTED IN PATIENT AFTER IOL EXCHANGE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 18516892 ↗