Clareon CCWTT4 (UDI 00380652457897)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652457897), received between Apr 4, 2023 and Feb 21, 2025 — classified as 5 injuries, 1 malfunction.

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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 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 HAD FOGGY AND GLARE ISSUES. THE IOL WAS EXCHANGED FOR NON COMPANY LENS MODEL 8 MONTHS AND 7 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS IOL CALCULATIONS. 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; Visual Disturbances

  MAUDE report 21434336 ↗
• InjuryAug 13, 2024Malposition of Device; Malposition of Device

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR VISION. CLINICAL REASON MENTIONED AS IMPLANTED LENS WAS DECENTERED. ON RE-RUNNING CALCULATIONS FOLLOWING EVALUATION, SURGEON ALSO DECIDED THAT ORIGINALLY PRESCRIBED TORICITY WAS INSUFFICIENT AND REQUESTED TO EXCHANGE T4 FOR T5. THE IOL WAS EXPLANTED AND EXCHANGED WITH ANOTHER LENS FOLLOWING THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION RECEIVED STATING THAT THERE WAS NO PATIENT HARM.

  Patient problems: Visual Impairment

  MAUDE report 19973827 ↗
• InjuryJul 29, 2024Defective Device; Defective Device

  ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THE LENS WAS IMPLANTED BUT THEN EXPLANTED AND REPLACED AFTER LENS WOULD NOT REMAIN CENTERED IN PATIENTS EYE RELATED TO TERMINAL HAPTIC MISSING. BROUGHT BACK FOR SURGERY WITHIN 3 WEEK PERIOD TO REMOVE AND REPLACE. THE ISSUE WITH THE LENS WAS NOT DISCOVERED UNTIL THE POSTOPERATIVE PERIOD.

  Patient problems: Visual Impairment

  MAUDE report 19849651 ↗
• InjuryJun 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A CONSUMER REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT COULD NOT SEE CLEARLY MORE THAN FIVE FEET AWAY, THE VISION WAS BLURRY AT DISTANCE, AND PATIENT COULD NOT DRIVE SINCE THE SURGERY. THE PATIENT WAS GIVEN GLASSES AND THAT CLEARED THE DISTANCE VISION. PATIENT'S VISION WAS GREAT FOR READING NEAR AND INSIDE THE HOME. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING- AFTER THE SURGERIES, THE SURGEON SAID PATIENT'S LENSES HAD "SHIFTED". THE SURGEON SAID THE VISION WOULD NOT IMPROVE AT DISTANCE. IT WAS TOLD THAT PATIENT WAS NOT NEURO-ADAPTING TO THE LENS AND MUST BE INTOLERANT. THE SURGEON PERFORMED YTTRIUM-ALUMINUM-GARNET (YAG) LASER IN THE RIGHT EYE, BUT PATIENT DID NOT FEEL THAT THE VISION WAS IMPROVED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 17070025 ↗
• InjuryJun 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A CONSUMER REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT COULD NOT SEE CLEARLY MORE THAN FIVE FEET AWAY, THE VISION WAS BLURRY AT DISTANCE, AND PATIENT COULD NOT DRIVE SINCE THE SURGERY. THE PATIENT WAS GIVEN GLASSES AND THAT CLEARED THE DISTANCE VISION. PATIENT'S VISION WAS GREAT FOR READING NEAR AND INSIDE THE HOME. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING- AFTER THE SURGERIES, THE SURGEON SAID PATIENT'S LENSES HAD "SHIFTED". THE SURGEON SAID THE VISION WOULD NOT IMPROVE AT DISTANCE. IT WAS TOLD THAT PATIENT WAS NOT NEURO-ADAPTING TO THE LENS AND MUST BE INTOLERANT. 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 17070018 ↗
• MalfunctionApr 4, 2023Malposition of Device; Malposition of Device

  A SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT VISION WAS 20/25 WITH AUTOREFRACTION +1.00 -0.75 X 167, AT 2 WEEKS POST OP UNCORRECTED VISION DECREASED TO 20/80 WITH MANIFEST REFRACTION +1.25 -3.00 X15 WITH CORRECTED VISION 20/15. THE PLANNED AXIS OF IOL WAS 103DEGREES. AT 2 WEEKS THE IOL WAS FOUND TO HAVE ROTATED TO AXIS 180. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16675138 ↗