Clareon CCWTT4 (UDI 00380652457866)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652457866), received between Sep 28, 2022 and Oct 15, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT HAD A POSSIBLE TORN CAPSULE. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY AND THERE WAS NO FURTHER IMPACT TO THE PATIENT. IN THE SURGEON¿S OPINION, THE PRODUCT DID NOT CONTRIBUTE TO OR CAUSE THE EVENT. PATIENT ISSUE WAS RESOLVED AND IN THE SURGEON¿S PROGNOSIS THE PATIENT VISION WAS IMPROVED.

  Patient problems: Capsular Bag Tear

  MAUDE report 23299241 ↗
• InjuryOct 15, 2025Optical Decentration; Material Twisted/Bent; Optical Decentration; Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED BLURRY VISION. HENCE THE LENS WAS EXPLANTED. THE CLINICAL REASON FOR EXPLANT WAS DECENTERED IOL (INTRAOCULAR LENS) - ONE OF THE HAPTIC NOT FULLY EXTENDED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 23289714 ↗
• InjuryMar 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS ASTIGMATIC SURPRISE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 16527278 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR VISION QUALITY VISION AND NOT IMPROVED WITH THE REFRACTION/DRY EYE THERAPY. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND PROVIDED THAT THERE WAS NO PATIENT HARM AND NO HOSPITALIZATION. THE PATIENT HAD DOUBLE VISION, UNHAPPY WITH DISTANCE AND NEAR VISION.

  Patient problems: Blurred Vision; Dry Eye(s); Visual Impairment

  MAUDE report 15975943 ↗
• MalfunctionSep 28, 2022Device Contamination with Chemical or Other Material; Scratched Material; Device Contamination with Chemical or Other Material; Scratched Material

  AN OPHTHALMIC SURGEON REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A LONG (2.5MM) BLEMISH WAS OBSERVED, CENTRAL ANTERIOR ON THE IOL. ATTEMPTED TO ASPIRATE THE BLEMISH WAS INITIALLY WITH IRRIGATION AND ASPIRATION AND DID APPEAR TO REMOVE SOME OF THE BLEMISH. A CENTRAL SCRATCH STILL APPEARED AND PHYSICAL CONTACT WITH SINSKY TYPE INSTRUMENT WAS USED TO TRY AND REMOVE BLEMISH, AS WELL AS CONTINUED ASPIRATION, BUT WAS NOT EFFECTIVE. LENS WAS THEN EXCHANGED. ADDITIONAL INFORMATION WAS RECEIVED STATING THE BLEMISH ON THE IOL WAS LOCATED ON THE CENTRAL ANTERIOR SIDE. IT WAS ORIGINALLY AN APPROXIMATELY 1.5-2.0 MM BLEMISH IN A LINE. AFTER COPIOUS IRRIGATION AND MANIPULATION TRYING TO REMOVE, SOME OF THE BLEMISH WAS REMOVED; HOWEVER, AN APPROXIMATE 1MM LINE WAS STILL ON THE IOL AND COULD NOT BE REVIVED.

  Patient problems: Insufficient Information

  MAUDE report 15495686 ↗