Clareon CCWTT3 (UDI 00380652457330)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652457330), received between Mar 5, 2024 and Mar 30, 2026 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  A NONHEALTH CARE PROFESSIONAL REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE DUE TO UNKNOWN ISSUE. ADDITIONAL INFORMATION REQUESTED AND RECEIVED STATING THAT THE LENS WAS EXCHANGED FOR A NON COMPANY LENS. NO PATIENT HARM AND THE SURGEONS PROGNOSIS WAS NOTED AS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24723822 ↗
• MalfunctionJul 30, 2025Material Twisted/Bent; Material Twisted/Bent

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, UPON LOADING LENS IT WAS NOTED THAT ONE OF THE HAPTICS WAS MALFORMED/DISTORTED. A NEW LENS WAS IMPLANTED AND COMPLETED THE PROCEDURE ON THE SAME DAY. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS RECEIVED; THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22662947 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD EXPERIENCED VERY BLURRY VISION. THE BLURRINESS PERSISTED FOR ABOUT THREE WEEKS UNTIL HER EYE PRESSURE RETURNED TO 14. THE CONSUMER BELIEVED THAT, DUE TO THE MISSHAPEN CORNEA, THE 17.5-DIOPTER LENS WAS THE WRONG STRENGTH. THE PATIENT REQUIRED 3.75-DIOPTER READING GLASSES, 2-DIOPTER GLASSES FOR COMPUTER USE, AND 1-DIOPTER GLASSES FOR DRIVING. THE PATIENT HAD A GOOD OUTCOME AFTER SURGERY, HOWEVER WAS DUE FOR A (YTTRIUM ALUMINUM GARNET) YAG LASER CAPSULOTOMY IN ORDER TO OPTIMIZE THE LENS OUTCOME WHICH WAS ORDERED BY THE SURGEON IN (B)(6) 2024 AT A POSTOPERATIVE VISIT THE PATIENT HAD SCHEDULED THE YAG PROCEDURE FOR (B)(6) 2024 BUT THEN CANCELED IT. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Blurred Vision; Intraocular Pressure Increased

  MAUDE report 22577922 ↗
• InjuryFeb 6, 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 WITH BLURRY VISION AT ALL DISTANCES AND GLARE. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 01 MONTH 05 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS VISION AND BEST CORRECTED ACUITY DECREASED WITH COMPANY LENS. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: Blurred Vision; Insufficient Information; Visual Disturbances

  MAUDE report 21321794 ↗
• InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED GLARE AND VISUAL DISTORTION, HALOS AND NEGATIVE DYSPHOTOPSIA. THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) AFTER THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANTATION WAS MECHANICAL COMPLICATION WITH PROSTHETIC LENS, NEGATIVE DYSPHOTOPSIA SIGNIFICANT GLARE AND HALOS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 21265661 ↗
• InjuryMar 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 DOES NOT LIKE THE MULTIFOCAL LENS. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS PATIENT UNHAPPY WITH THE MULTIFOCAL LENS.

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

  MAUDE report 18835871 ↗