Clareon CCWET3 (UDI 00380652455190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652455190), received between Dec 27, 2022 and Mar 14, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 14, 2025Adverse 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, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO PATIENT EXPERIENCED POOR VISION ACUITY. CLINICAL REASON FOR EXPLANT WAS REPORTED TO BE RESIDUAL ASTIGMATISM. THE IOL WAS REPLACED WITH UNSPECIFIED LENS APPROXIMATELY FIVE MONTHS AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 21606204 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE ON (B)(6) IN THE LEFT EYE, DISAPPOINTED IN THAT THE INTERMEDIATE VISION FOCAL LENGTH, WHILE IMPROVED, WAS NOT 20/20, PATIENT WAS REFERRING TO A RANGE OF 5 TO 20 FEET IN DISTANCE. IN PARTICULAR, WATCHING A 65' HIGH DEF TV WITH UHD STILL REQUIRES GLASSES TO ACHIEVE COMPLETE ACUITY AND SHARPNESS. ESTIMATED VISION AT THAT DISTANCE TO BE ABOUT 20/25. CONSUMER AGREES THAT THE LONG RANGE (I.E., DRIVING) WAS 20/20 AND COULD USUALLY MAKE OUT INSTRUMENT PANEL IN THE CAR, BUT SOMEWHAT BLURRED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THE PATIENT WANTED TO KNOW WHY HIS LEFT EYE VISION WAS NOW LESS THAN THE RIGHT WHEN IT WAS THE STRONGER OF THE TWO MID RANGE. AND WHY "FUNCTIONAL VISION" WAS WORSE FOR CLOSE RANGE THAN BEFORE THE IMPLANTS. WHILE HE EAT OR READ, MY FOOD OR PHONE WAS BLURRY THAN PRIOR TO IMPLANTS. THE PRESCRIPTION WAS THE CURRENT GLASSES THAT HE WEAR TO WATCH TV AND READ THE COMPUTER. PATIENT EXPERIENCED NIGHT TIME DRIVING HARDER THAN BEFORE. HAD HALOS AND TAIL LIGHTS WERE LIKE STARBURSTS. HE STARTED EXPERIENCING SYMPTOMS ONE MONTH AFTER SURGERY. LEFT EYE WAS THE STRONGER (SHARPER)

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 20037988 ↗
• InjuryApr 25, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY, SLIGHT TORIC ROTATION AND UNDER CORRECTION OF ASTIGMATISM. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 1 MONTHS 6 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE SURGEONS PROGNOSIS WAS MENTIONED AS GOOD.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 19181658 ↗
• MalfunctionDec 27, 2022Defective Device; Difficult to Advance; Defective Device; Difficult to Advance

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING UPON INJECTION OF THE LENS THE DOCTOR NOTED THAT HE DID NOT LIKE THE APPEARANCE OF THE LENS. THE SURGERY WAS COMPLETED WITH A BACK UP LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT IN THE PROCESS OF BEING INJECTED INTO THE PATIENT'S EYE, THE LENS WAS NOT INJECTING PROPERLY. THE SURGICAL TECHNICIAN RELOADED THE LENS AND A SECOND INJECTION WAS ATTEMPTED. UPON INJECTION OF THE LENS, THE DOCTOR DID NOT LIKE THE APPEARANCE OF THE LENS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16050832 ↗