Clareon CCWET0 (UDI 00380652405713)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380652405713), received between Sep 11, 2023 and Dec 4, 2025 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2025Adverse 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 PATIENT WAS UNHAPPY WITH VISION AND WAS NOT ABLE TO READ. CLINICAL REASON BEING MENTIONED AS PATIENT VISION WAS IMPACTING HER ACTIVITIES OF DAILY LIVING. THE IOL WAS EXPLANTED AND EXCHANGED WITH AN UNSPECIFIED ATIOL (ADVANCED TECHNOLOGY INTRAOCULAR LENS) IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 23716505 ↗
• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED VISUAL ISSUE WITH LIGHTS. THE IOL WAS REPLACED WITH A UNSPECIFIED MONOFOCAL IOL 1 MONTH, 2 WEEKS, 1 DAY AFTER THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON PROVIDED FOR EXPLANT WAS DYSPHOTOPSIAS. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 22877217 ↗
• InjuryMay 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD POOR VISION. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS IOL DISLOCATION AT POST OPERATIVE VISIT 3. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 22034079 ↗
• MalfunctionMay 6, 2025Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE LENS DAMAGED WHEN OPENED/PRIOR TO USE. IT WAS ALSO STATED AS FREQUENT. THERE WAS PATIENT CONTACT WHILE IOL WAS BEING INSERTED. THE PROCEDURE COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE LENS HAD A SCRATCH. THERE WAS NO PATIENT HARM. SYMPTOMS RESOLVED. PROCEDURE WAS COMPLETED WITH AN ANOTHER LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21966687 ↗
• InjuryApr 21, 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 HAS NO RANGE OF VISION· PATIENT WAS SEEING 20/25 DISTANCE, J10 NEAR. THE PATIENT WAS REFRACTING AT MINUS·25· SURGEON TRIED A PLUS 1 AND PLUS 1·5 CONTACT LENS TO SEE IF PATIENT COULD GET MORE NEAR AND INTERMEDIATE WITH NO EFFECT· PRE-OPERATIVE MEASUREMENTS ALL CONSISTENT, MINIMAL ASTIGMATISM, NO MACULAR ISSUES· CORNEA IS CLEAR· LENS IS WELL CENTERED AND NORMAL PUPIL SIZE. ADDITIONAL INFORMATION WAS RECEIVED, THE LENS WAS EXPLANTED AND REPLACED WITH UNSPECIFIED LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE PATIENT HAD EXCELLENT DISTANCE VISION BUT NO NEAR VISION. NO PATIENT HARM WAS REPORTED.

  Patient problems: Blurred Vision

  MAUDE report 21874314 ↗
• MalfunctionApr 18, 2025Break; Break

  A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS BROKEN. ADDITIONAL INFORMATION WAS RECEIVED AS THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21866837 ↗
• InjuryNov 15, 2024Optical Decentration; Optical Decentration

  ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING IOL WAS REPLACED WITH SAME COMPANY NON-TORIC DIFFERENT MODEL DIFFERENT DIOPTER LENS.

  Patient problems: Blurred Vision

  MAUDE report 20696087 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD SIGNIFICANT AMOUNT OF CAPSULAR PHIMOSIS AND THE BAG WAS TOO TIGHT TO GET THE IOL OUT. THE POSTERIOR CAPSULE FORMED A RENT IN THE ATTEMPTED IOL EXCHANGE AND THE LENS COULD NOT BE EXPLANTED. THE PATIENT WAS TOLD BEFORE SURGERY THAT THE LENS EXCHANGE MIGHT NOT BE POSSIBLE. THEREFORE, THE LENS REMAINS IMPLANTED.

  Patient problems: Blurred Vision; Capsular Bag Tear; Capsular Contracture

  MAUDE report 18837144 ↗
• InjurySep 11, 2023Malposition of Device; Malposition of Device

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS DISLOCATED. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON WAS EXPLANT WAS LENS DISLOCATION. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THERE WAS NO PATIENT HARM, IN THE SURGEON'S OPINION, THE PROGNOSIS OF THE PATIENT WAS EXCELLENT.

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

  MAUDE report 17720613 ↗
• InjurySep 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN OTHER HEALTH CARE PROFESSIONAL REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT HAD POOR DISTANCE VISION. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS, MYOPIC POWER MISS. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 17718562 ↗