Clareon CCWET3 (UDI 00380652486026)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652486026), received between Apr 12, 2023 and Oct 13, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Malposition of 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 18, 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.

• InjuryOct 13, 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 IMPLANTATION SURGERY, THE PATIENT EXPERIENCED FUSSY VISION AND HAD ISSUES SEEING COMPUTER. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS OTHER MECHANICAL COMPLICATIONS OF LENS. THERE WAS NO PATIENT HARM AND AS PER THE SURGEON'S OPINION, THE PROGNOSIS OF THE PATIENT WAS GOOD.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 17931833 ↗
• InjuryAug 8, 2023Adverse 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, THE PATIENT HAD DECREASED NEAR VISION, COULD NOT READ SMALL PRINT AND DIM LIGHT, COULD NOT READ FROM COMPUTER, IPAD, CELL PHONE AND BOOKS. LIGHTS CONSTANTLY GAVE A SMALL RAINBOW AT EDGE OF RIGHT EYE IF REFLECTED A CERTAIN WAY. THE PATIENT ALSO HAD SOME STROBE LIKE ISSUES WHEN GOING FROM INSIDE TO OUTSIDE AND ANY CHANGE IN LIGHTING. THE PATIENT WAS TOLD HER RETINA WAS FINE AND NEED READING GLASSES SO THAT SHE COULD READ AND TO COMPLETE HER ROUTINE ACTIVITIES. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Headache; Visual Impairment

  MAUDE report 17478291 ↗
• InjuryMay 3, 2023Malposition of Device; Malposition of Device

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY / POOR VISION. THE LENS WAS EXPLANTED AND REPLACED WITH OTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS DECENTERED INTRAOCULAR LENS OPTIC / HAPTIC IRREGULARITY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 16859503 ↗
• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER IMPLANTATION OF INTRAOCULAR LENS (IOL), THE PATIENT WAS UNHAPPY WITH THE VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH ANOTHER LENS. THE CLINICAL REASON FOR EXPLANT WAS REFRACTIVE SURPRISE/RESIDUAL MYOPIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 16724581 ↗