Clareon CCWTT0 (UDI 00380652413510)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652413510), received between Dec 28, 2023 and Aug 2, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Eject” (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.

• InjuryAug 2, 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 VISION AND ALSO NEED READERS MORE OFTEN THAN HE WOULD LIKE. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 19890587 ↗
• InjuryJun 24, 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, PATIENT EXPERIENCED BLURRY REFLECTION DURING CHANGES OF LIGHT, UNDER FLUORESCENT LIGHTS AND WHILE DRIVING AND HAD EYE DISCOMFORT SINCE SURGERY WHICH WAS 7 MONTHS AGO. ADDITIONAL INFORMATION RECEIVED AND STATED THAT PATIENT EXPERIENCED DISCOMFORT TRIGGERED BY LIGHT, PARTICULARLY WHEN USING IPAD OR WATCHING TELEVISION. PATIENT WEAR SUNGLASSES EVEN INDOORS AND IT FEELS AS THE EYEBALLS IS CONTRACTING. IT WAS DIFFICULT TO FIND THE WORDS FOR AN ADEQUATE DESCRIPTION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Visual Disturbances

  MAUDE report 19593077 ↗
• MalfunctionFeb 15, 2024Failure to Eject; Failure to Eject

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY,THE LENS WOULD NOT ADVANCE IN THE CARTRIDGE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS RECEIVED AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18710985 ↗
• InjuryDec 28, 2023Adverse 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 COULD NOT ADAPT TO THE MULTIFOCAL LENS IMPLANTED. THE LENS WAS REMOVED AND REPLACED WITH A MONOFOCAL LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED. ACCORDING TO THE SURGEON THE IOL DID NOT CONTRIBUTE TO THE EVENT, THE PATIENT SIMPLY COULDN'T ADAPT TO THE MULTIFOCAL LENS. A NON-COMPANY LENS WAS USED AS REPLACEMENT.

  Patient problems: Visual Impairment

  MAUDE report 18408582 ↗