Clareon CCWET0 (UDI 00380652405720)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652405720), received between Feb 9, 2023 and Sep 26, 2025 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Application Program Problem: Power Calculation Error” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE NEW INFORMATION RECEIVED, THERE WAS NO FURTHER IMPACT TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON 01-OCT-2025 CLARIFIED THAT THE LENS ORIGINALLY IMPLANTED WAS ACTUALLY THE REPLACEMENT LENS. THE IOL EXCHANGE WAS DONE WITH A COMPANY LENS OF SAME MODEL BUT DIFFERENT DIOPTER. THIS SUGGESTS AN EFFORT TO ADJUST THE REFRACTIVE OUTCOME, LIKELY BECAUSE THE INITIAL LENS POWER DID NOT ACHIEVE THE DESIRED RESULT.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 23154204 ↗
• MalfunctionFeb 4, 2025Scratched Material; Scratched Material

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SCRATCH ON THE LENS WAS NOTICED SO THE NEW UNSPECIFIED LENS WAS OPENED AND IMPLANTED. ADDITIONAL INFORMATION HAS RECEIVED AND IT STATED THAT THERE WAS NO PATIENT CONTACT AND SCHEDULED PROCEDURE COMPLETED ON THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21303253 ↗
• InjuryOct 23, 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 VISION. THE LENS WAS EXCHANGED FOR NON-COMPANY LENS MODEL 2 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT SYMPTOMS WERE IMPROVING. THERE WAS NO PATIENT IMPACT.

  Patient problems: Blurred Vision

  MAUDE report 20516765 ↗
• InjuryJul 12, 2023Application Program Problem: Power Calculation Error; Application Program Problem: Power Calculation Error

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WOULD LIKE TO HAVE MORE NEAR VISION ACUITY. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 4 WEEKS FOLLOWING THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REFRACTIVE ERROR ON PRE-OP CALCULATIONS. THERE WAS NO PATIENT HARM.

  Patient problems: Visual Impairment

  MAUDE report 17306112 ↗
• MalfunctionMay 25, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, A FIBER EMBEDDED INSIDE THE INTRAOCULAR LENS (IOL) WAS NOTICED AFTER IT WAS IMPLANTED. THE SURGEON ATTEMPTED TO POLISH BOTH ANTERIOR AND POSTERIOR SIDES OF THE LENS WITHOUT ANY SUCCESS. THE LENS REMAINS IMPLANTED IN PATIENT'S EYE, AS SURGEON BELIEVED IT WOULD NOT IMPACT THE PATIENT'S VISION.

  Patient problems: Insufficient Information

  MAUDE report 17002676 ↗
• MalfunctionMay 19, 2023Crack; Crack

  A FACILITY REPRESENTATIVE REPORTED AFTER IMPLANTATION OF INTRAOCULAR LENS (IOL), A CRACK OR TORN ON LENS NOTICED. THE LENS WAS REMOVED DURING INITIAL AND REPLACED WITH SAME MODEL LENS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16960382 ↗
• InjuryFeb 9, 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 WAS UNABLE TO SEE PHONE AND COMPUTER. THE VISION WAS DECREASED INTERFERING WITH DAILY ACTIVITIES. THE IOL WAS EXPLANTED AND EXCHANGED IN A SECONDARY PROCEDURE FOR ATIOL (ADVANCE TECHNOLOGY INTRAOCULAR LENS). ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT SMALL PERCENTAGE OF PATIENTS WILL REQUIRE GLASSES FOR A NEAR VISION. THE IOL WAS EXCHANGED FOR A NON COMPANY LENS, THE PATIENT ISSUE WAS RESOLVED AND THERE WAS NO PATIENT HARM, THE PATIENT WAS NOT HOSPITALIZED. THE SURGEON PROGNOSIS WAS EXCELLENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 16335865 ↗