Clareon CCWTT0 (UDI 00380652413657)Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00380652413657), received between Oct 3, 2022 and Apr 22, 2026 — classified as 41 injuries, 7 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 48 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD SIGNIFICANT GLARE COMPLAINTS AND FELT QUALITY OF DISTANCE VISION WAS POOR DESPITE BEING 20/20. THE LENS EXCHANGE WAS PLANNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE IOL WAS EXCHANGED FOR NON-COMPANY LENS IN A SECONDARY PROCEDURE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24955240 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DEFECT NOTED ON POSTERIOR CAPSULE. THE LENS WAS REMOVED DURING INITIAL PROCEDURE.ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Capsular Bag Tear

  MAUDE report 24528260 ↗
• InjuryOct 23, 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 GLARE, HALOS. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS DYSPHOTOPSIA AND HALOS.

  Patient problems: Visual Disturbances

  MAUDE report 23365145 ↗
• InjuryJul 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) IMPLANTATION PROCEDURE, THE PATIENT DID NOT ADAPTED TO THE IOL TECHNOLOGY. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE 1 MONTH, 2 WEEKS, AND 6 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS AN EPIRETINAL MEMBRANE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Retinal Degeneration

  MAUDE report 22585818 ↗
• InjuryJun 13, 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 EXPERIENCED BLURRY DISTANCE VISION, AS WELL AS BLURRY INTERMEDIATE AND NEAR VISION. THE CLINICAL REASON PROVIDED WAS THAT THE PATIENT WAS UNABLE TO ADAPT TO THE TECHNOLOGY. THE IOL WAS REPLACED WITH A NON-COMPANY MONOFOCAL IOL 3 MONTHS, 23 DAYS AFTER THE INITIAL IMPLANT PROCEDURE, WITH NO PATIENT HARM.

  Patient problems: Blurred Vision

  MAUDE report 22203784 ↗
• MalfunctionJun 4, 2025Device Difficult to Setup or Prepare; Scratched Material; Device Difficult to Setup or Prepare; Scratched Material

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WONT LOAD PROPERLY AND SURGEON INFORMED THAT THERE WAS A SCRATCH ON IT. LENS DID NOT COME IN CONTACT WITH THE PATIENT AND NO PATIENT HARM WAS REPORTED. A NEW LENS WAS OPENED AND COMPLETED THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22143081 ↗
• InjuryApr 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 POOR VISION WHICH WAS ALWAYS BLURRY. CLINICAL REASON BEING MENTIONED AS POOR VISION AFTER SURGERY. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN MONOFOCAL LENS IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 21874793 ↗
• InjuryDec 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED AND REPORTED THAT THE IOL WAS EXCHANGED FOR THE DIFFERENT LENS MODEL WITH ONE AND 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

  MAUDE report 21047303 ↗
• InjuryNov 28, 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 EXPLANTED THE LENS WITH THE REASON MALADAPTATION TO THE LENS. THE LENS EXCHANGED WITH NON COMPANY LENS 5 MONTHS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS FOGGINESS AND HALOS. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: Blurred Vision; Halo; Visual Impairment

  MAUDE report 20805183 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE LENS WAS REPLACED WITH NON COMPANY 20.0 D LENS.

  Patient problems: Visual Disturbances

  MAUDE report 20695946 ↗
• InjuryOct 9, 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. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20405988 ↗
• InjuryOct 4, 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 BLURRED VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 28 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS PSEUDOPHAKIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20365889 ↗
• InjurySep 25, 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) IMPLANTATION PROCEDURE, PATIENT HAD POOR NEAR VISION ACUITY, HALOS, AND SHADOWING. THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL), 3 MONTH AND 25 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON WAS MALADAPTATION TO MULTIFOCAL INTRAOCULAR LENS (MFIOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Diplopia/Double Vision; Halo

  MAUDE report 20304886 ↗
• InjurySep 12, 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 BLURRY DISTANCE AND INTERMEDIATE VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 4 MONTHS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS PATIENT WAS UNABLE TO ADAPT TO TECHNOLOGY.

  Patient problems: Blurred Vision

  MAUDE report 20201320 ↗
• InjurySep 11, 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 SEVERE HALOS AFFECTING ACTIVITIES OF DAILY LIVING. CLINICAL REASON FOR EXPLANT CANNOT TOLERATE HALOS AND WAXY VISION. THE IOL WAS EXCHANGED FOR ANOTHER MODEL COMPANY LENS 18 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS SECOND REPORT ASSOCIATED WITH THE ONE OF THE EYE.

  Patient problems: Blurred Vision; Halo

  MAUDE report 20189703 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATING THAT THE PATIENT WAS UNHAPPY WITH QUALITY OF VISION. AS PER SURGEON¿S OPINION PRODUCT CONTRIBUTED TO EVENT. THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision; Halo

  MAUDE report 20178603 ↗
• 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 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 RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20178581 ↗
• InjurySep 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT EXPERIENCED, NIGHT VISION PROBLEMS AND HALOS. THE LENS WAS REMOVED AND REPLACED WITH A MONOFOCAL LENS IN SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 20168480 ↗
• InjurySep 5, 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 3 MONTHS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS MALADAPTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20143299 ↗
• InjurySep 4, 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. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO LEFT EYE.

  Patient problems: Blurred Vision

  MAUDE report 20135792 ↗
• 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 16 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 20133543 ↗
• InjuryJun 27, 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 QUALITY OF VISION. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL- MONOFOCAL LENS 4 MONTHS 19 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING NO HARM AFTER REPLACEMENT.

  Patient problems: Visual Impairment

  MAUDE report 19628910 ↗
• InjuryJun 24, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POSTERIOR CAPSULAR TEAR AND DISPLACEMENT. CLINICAL REASON WAS MENTIONED DIPLOPIA. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Capsular Bag Tear; Diplopia/Double Vision

  MAUDE report 19594940 ↗
• InjuryJun 20, 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 EXPERIENCED STRANGE VISION, SEES SECOND IMAGE AND DIFFICULTY WITH NEAR AND DISTANT VISION . THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

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

  MAUDE report 19575061 ↗
• InjuryMay 8, 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 BLURRED VISION AT ALL RANGE AND GLARE. CLINICAL REASON FOR EXPLANT WAS FAILURE TO ADJUST. THE IOL WAS EXCHANGED FOR MONOFOCAL LENS MODEL 3 MONTHS 21 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 19270219 ↗