Clareon CCWTT3 (UDI 00380652457347)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00380652457347), received between Apr 19, 2023 and Aug 13, 2026 — classified as 11 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem

  A non-health care professional reported that following an intraocular lens (IOL) implantation procedure, the patient experienced difficulty seeing. Subsequently the lens was removed and replaced with an unspecified advanced technology intraocular lens (ATIOL) in a secondary procedure. The clinical reason for explant was mechanical breakdown of intraocular lens. Additional information has been requested but is not available at the time of this report.

  Patient problems: Blurred Vision

  MAUDE report 50233332 ↗
• InjuryAug 22, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED STATING PATIENT CONTINUES TO COMPLAIN VISION IS NOT GREAT- YAG WAS SCHEDULED. THERE WAS NO FURTHER IMPACT TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 22873294 ↗
• InjuryJul 11, 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 HAD DECREASED VISUAL ACUITY SINCE THE LAST VISIT, BLURRINESS FOR 2 MONTHS AND HALOS WHILE DRIVING AT NIGHT. CLINICAL REASON IS PATIENT EXPERIENCING DYSPHOTOPSIA. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) 3 MONTHS, 3 WEEKS, 2 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT PATIENT HAD SYMPTOM OF DIFFICULT TO READ.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22480280 ↗
• InjuryMay 23, 2025Particulates; Device Dislodged or Dislocated; Particulates; Device Dislodged or Dislocated

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED WITH POSTERIOR CAPSULE OPACIFICATION (PCO) AND THE IOL WAS ROTATED. A GRADE 2 PCO WAS IDENTIFIED AFTER 3 MONTHS POST-OPERATIVE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT STATED THAT THE GRADE 2 PCO AT 3 MONTHS, IOL WAS ROTATED AXIS FROM 12 DEGREES TO 30 DEGREES, CONCERNED REGARDING THE LENS MATERIAL VERSES CARTRIDGE MATERIAL CAUSING THE LENS TO BE SLICK AND ROTATE. THE SURGEON NOTICED CARTRIDGE MATERIAL ADHERES TO POSTERIOR SURFACE OF LES REQUIRING REMOVAL WITH IRRIGATION AND ASPIRATION BUT THAT CAN SOMETIMES BE DIFFICULT. . THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Posterior Capsule Opacification; Vitreous Floaters

  MAUDE report 22077187 ↗
• MalfunctionMay 21, 2025Device Difficult to Setup or Prepare; Material Split, Cut or Torn; Device Difficult to Setup or Prepare; Material Split, Cut or Torn

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS LOADING ERROR. THE LENS WAS TORN DURING THE IMPLANTATION. THE LENS WAS IMPLANTED AND REMOVED ON THE SAME DAY, A BACK UP LENS OF SAME MODEL AND DIOPTER WAS IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, IN THE SURGEON'S OPINION THE CAUSE OF THE EVENT WAS DUE TO LOADING ERROR. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22062806 ↗
• InjuryApr 15, 2025Particulates; Device Dislodged or Dislocated; Particulates; Device Dislodged or Dislocated

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED WITH POSTERIOR CAPSULE OPACIFICATION (PCO) AND THE IOL WAS ROTATED. A GRADE 2 PCO WAS IDENTIFIED AFTER 3 MONTHS POST-OPERATIVE. 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: Posterior Capsule Opacification

  MAUDE report 21839908 ↗
• InjuryMar 14, 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, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO GLARE AND HALOS WITH NIGHT VISION- COULD NOT DRIVE. CLINICAL REASON FOR THE EXPLANT IS HALOS AND DYSPHOTOPSIA MAKING VISION INTOLERABLE. THE IOL WAS REPLACED WITH UNSPECIFIED MONOFOCAL LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 21603731 ↗
• InjuryDec 10, 2024Use of Incorrect Control/Treatment Settings; Defective Device; Use of Incorrect Control/Treatment Settings; Defective Device

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION, PATIENT'S DISTANCE VISION NOT GOOD, NEAR WAS OK. THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON IOL MALFUNCTION. ADDITIONAL INFORMATION RECEIVED STATING THAT DISTANCE VISION WAS BLURRY AND HAD A HARD TIME WATCHING THE TV. AFTER INITIAL IMPLANT PROCEDURE VISUAL ACUITY WAS 20/150 AND INTRAOCULAR PRESSURE (IOP) WAS 22 MMHG. THE POST-OPERATIVE MEASUREMENTS AFTER LENS EXCHANGE VISUAL ACUITY WAS 20/40 AND IOP WAS 9 MMHG. IN THE SURGEON¿S OPINION PRODUCT DID NOT CONTRIBUTE TO THE EVENT. IN THE SURGEON¿S OPINION HIGH MYOPIC SURPRISE CAUSED THE EVENT.

  Patient problems: Blurred Vision; Intraocular Pressure Increased; Visual Impairment

  MAUDE report 20894304 ↗
• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MATERIALS MANAGER REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT COULD NOT READ ROAD SIGNS. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS MYOPIC SURPRISE IN DOMINANT EYE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 20208137 ↗
• InjuryDec 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED AN THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED VISUAL ACUITY IS HORRIBLE .CLINICAL REASON FOR EXPLANT WAS UNABLE TO CORRECT VISION THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL TWO MONTHS 23 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED NO PATIENT HARM REPORTED.

  Patient problems: Visual Impairment

  MAUDE report 18417799 ↗
• InjurySep 13, 2023Malposition of Device; Material Split, Cut or Torn; Malposition of Device; Material Split, Cut or Torn

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, ON THE FIRST DAY THE LENS APPEARED ADEQUATELY CENTERED. AT ONE WEEK, THE PATIENT CONTINUED TO HAVE FAIRLY GOOD VISION WITH THE LEFT OF 20/30 AT DISTANCE AND J1 AT NEAR. LATER, SHE RETURNED TO PHYSICIAN COMPLAINING OF BLURRY VISION ON THE LEFT EYE, HER DISTANCE ACUITY HAD DECREASED TO 20/50 AND HER READING ACUITY HAD DECREASED TO J4 AND WAS SUBJECTIVELY QUITE BLURRY. THE LENS IMPLANT SHOWED SEVERE MEDIAL DECENTRATION AND A SHIFT IN THE AXIS OF ASTIGMATISM FROM 70 DEGREES TO 120 DEGREES. THERE WAS NO EVIDENCE OF VITREOUS PROLAPSE. THE CAPSULAR BAG APPEARED INTACT. SHE WAS TAKEN BACK TO SURGERY FOR A REPOSITIONING OF THIS LENS IMPLANT. THE LENS WOULD NOT CENTER. THE PHYSICIAN WAS ABLE TO FREELY MOBILIZE IT WITHIN THE CAPSULAR BAG. AT THAT TIME, AFTER EXTENSIVE ATTEMPTS AT RE-CENTERING THE LENS, SURGERY WAS TERMINATED WITH THE EXPECTATION THAT PHYSICIAN WOULD REASSESS THIS CLINICALLY AND CONSIDER LENS EXCHANGE. THE LENS FURTHER DECENTERED IN HER FIRST WEEK POSTOPERATIVELY RESULTING IN VISION OF 20/80 AT DISTANCE AND NO USEFUL READING VISION AT NEAR. LATER MONTH, PHYSICIAN REMOVED THE MULTIFOC

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 17737115 ↗
• InjuryAug 14, 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 WAS VERY BOTHERED BY THE VISION. THE PATIENT COULD NOT WORK OR FUNCTION PROPERLY AND IT WAS NOT GETTING BETTER WITH TIME. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE LENS WAS EXPLANTED AND REPLACED WITH OTHER COMPANY LENS. THERE WAS NO PATIENT HARM AND AS PER THE SURGEON'S OPINION, THE PROGNOSIS OF THE PATIENT WAS GOOD.

  Patient problems: Visual Disturbances

  MAUDE report 17541038 ↗
• MalfunctionApr 19, 2023Defective Component; Defective Component

  A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DEFECTIVE. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: Insufficient Information

  MAUDE report 16770504 ↗