Clareon CNWET0 (UDI 00380652405218)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380652405218), received between Jan 29, 2024 and Apr 1, 2026 — classified as 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Defective Device” (2 reports).

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2026Device Damaged by Another Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE IOL WAS BEING INSERTED THE LENS BROKE OFF THE EDGE NEAR THE HAPTIC. THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24756762 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DOES NOT FUNCTION AS DESIGNED. BEFORE SURGERY, PATIENT WAS EXPLICITLY ADVISED THAT THIS LENS WOULD FUNCTION AS A MULTIFOCAL OR EXTENDED VISION SOLUTION THEREFORE HE WOULD NOT NEED GLASSES AFTER IMPLANTATION. FOLLOWING IMPLANTATION, THE LENSES DID NOT FUNCTION AS REPRESENTED. HE WAS UNABLE TO SEE CLEARLY AT ANY DISTANCE WITHIN APPROXIMATELY FOUR FEET. NEAR AND INTERMEDIATE VISION, WHICH ARE CRITICAL FOR DAILY ACTIVITIES, WERE SIGNIFICANTLY IMPAIRED RATHER THAN IMPROVED. TO ADDRESS THESE FAILURES, HE WAS ADVISED TO UNDERGO PHOTOREFRACTIVE KERATECTOMY (PRK) SURGERY. PRK WAS PERFORMED IN BOTH EYES. HOWEVER, THE RESULT WAS NOT FUNCTIONAL BINOCULAR VISION. INSTEAD, HE WAS LEFT WITH ONE EYE PRIMARILY CORRECTED FOR DISTANCE AND THE OTHER FOR NEAR VISION. THIS RESULTED IN VISUAL IMBALANCE AND ONGOING DIFFICULTY WITH DEPTH PERCEPTION AND TASK FOCUS. THIS OUTCOME WAS NOT ACCEPTABLE FOR VISUAL NEEDS. HE WAS SUBSEQUENTLY ADVISED TO UNDERGO REQUIRED POSTERIOR CAPSULE OPACIFICATION SURGERY AND OBTAINED TWO INDEPENDENT SECOND OPINIONS, BOTH OF WHICH CONCLUDED THAT POSTERIOR CAPSULE OPACIFICA

  Patient problems: Blurred Vision; Foreign Body Sensation in Eye; Visual Disturbances

  MAUDE report 24222932 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DOES NOT FUNCTION AS DESIGNED. BEFORE SURGERY, PATIENT WAS EXPLICITLY ADVISED THAT THIS LENS WOULD FUNCTION AS A MULTIFOCAL OR EXTENDED VISION SOLUTION THEREFORE HE WOULD NOT NEED GLASSES AFTER IMPLANTATION. FOLLOWING IMPLANTATION, THE LENSES DID NOT FUNCTION AS REPRESENTED. HE WAS UNABLE TO SEE CLEARLY AT ANY DISTANCE WITHIN APPROXIMATELY FOUR FEET. NEAR AND INTERMEDIATE VISION, WHICH ARE CRITICAL FOR DAILY ACTIVITIES, WERE SIGNIFICANTLY IMPAIRED RATHER THAN IMPROVED. TO ADDRESS THESE FAILURES, HE WAS ADVISED TO UNDERGO PHOTOREFRACTIVE KERATECTOMY (PRK) SURGERY. PRK WAS PERFORMED IN BOTH EYES. HOWEVER, THE RESULT WAS NOT FUNCTIONAL BINOCULAR VISION. INSTEAD, HE WAS LEFT WITH ONE EYE PRIMARILY CORRECTED FOR DISTANCE AND THE OTHER FOR NEAR VISION. THIS RESULTED IN VISUAL IMBALANCE AND ONGOING DIFFICULTY WITH DEPTH PERCEPTION AND TASK FOCUS. THIS OUTCOME WAS NOT ACCEPTABLE FOR VISUAL NEEDS. HE WAS SUBSEQUENTLY ADVISED TO UNDERGO REQUIRED POSTERIOR CAPSULE OPACIFICATION SURGERY AND OBTAINED TWO INDEPENDENT SECOND OPINIONS, BOTH OF WHICH CONCLUDED THAT POSTERIOR CAPSULE OPACIFICA

  Patient problems: Blurred Vision; Foreign Body Sensation in Eye; Visual Disturbances

  MAUDE report 24222919 ↗
• MalfunctionJan 7, 2026Material Split, Cut or Torn

  A NONHEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF BROKEN. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23992284 ↗
• MalfunctionSep 11, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS DID NOT GO INTO THE EYE, BEFORE INSERTION SURGEON NOTICED THAT THE HAPTIC WAS SNAPPED OFF. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, A BACKUP LENS WAS USED TO COMPLETE THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23025396 ↗
• InjuryMay 13, 2025Adverse 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, THE PATIENT VISION WAS WORSE AFTER SURGERY THAN BEFORE. ADDITIONALLY PATIENT STATED THAT VISION WAS NOT CLEAR, EVEN WITH GLASSES AND THINGS HAVE A SHADOW OFF TO THE RIGHT, CANNOT DRIVE AT NIGHT DUE TO HALOS AND INABILITY TO SEE ROAD SIGNS. HAD SEEN A RETINAL SPECIALIST AND WAS TOLD EYES WERE FINE. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO LEFT EYE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22014690 ↗
• MalfunctionFeb 18, 2025Material Twisted/Bent; Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, UPON OPENING THE IOL IT WAS DISCOVERED THAT THE LENS WAS IMPROPERLY POSITIONED IN THE CONTAINER, RESULTED IN THE HAPTIC PART BEING BENT AT AN INCORRECT ANGLE AND CRUMPLED. THE LENS WAS IMPLANTED AND THE SURGERY WAS COMPLETED DESPITE THE DEFECT, AND THE SURGEON BELIEVED THAT THE LENS REMAINS A HIGH RISK OF IOL DECENTRATION DURING THE POSTOPERATIVE PERIOD. IT WAS ALSO STATED THAT REIMPLANTATION MAY BE REQUIRED. THE PATIENT WAS UNDER OBSERVATION. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE PATIENT CONDITION WAS SATISFACTORY WITH THE RESULTS OF DISTANCE VISION OF 100 PERCENT AND NEAR VISION 50 PERCENT AND NO REIMPLANTATION WAS REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 21393043 ↗
• MalfunctionOct 25, 2024Defective Device; Defective Device

  A FACILITY REPRESENTATIVE REPORTED THAT DURING SURGERY, THEY NOTICED AN IMPERFECTION ON THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20533510 ↗
• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, PATIENT HAD REFRACTIVE ERROR. THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) 1 MONTH AND 30 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON WAS MECHANICAL FAILURE OF IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 20247157 ↗
• MalfunctionSep 6, 2024Defective Component; Defective Component

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT LENS WAS DEFECTIVE. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE FROM THE PATIENT IT IS LEFT IN STORAGE FOR DELIVERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20156281 ↗
• InjuryJul 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION AND SHADOWS NEXT TO THE LETTERS WHEN READING SIGNS THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS POSITIVE DYSPHOTOPSIA. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Diplopia/Double Vision; Visual Disturbances

  MAUDE report 19773189 ↗
• MalfunctionJan 29, 2024Defective Device; Defective Device

  A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INTRAOCULAR LENS WAS DAMAGED AND LENS WAS REMOVED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18595569 ↗