Clareon CNW0T5 (UDI 00380652410663)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652410663), received between Mar 27, 2022 and Sep 21, 2026 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Crack” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  A pharmacist reported that during an intraocular lens (IOL) implantation procedure, capsular rupture, no capsular bag. Additional information has been requested but is not available at the time of this report.

  Patient problems: Capsular Bag Tear

  MAUDE report 50841402 ↗
• MalfunctionOct 18, 2025Material Deformation; Material Deformation

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS UNUSABLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23332084 ↗
• InjuryDec 5, 2024Defective Device; Device Dislodged or Dislocated; Defective Device; Device Dislodged or Dislocated

  A SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURFACE DEFECT NEAR THE OPTICAL AXIS WAS FOUND ON IOL INITIALLY WHICH WAS IGNORED DURING THE INITIAL IMPLANTATION BECAUSE IT WAS THOUGHT TO BE AN ACCUMULATION OF VISCOELASTIC. BEFORE EXPLANTATION, AN ATTEMPT WAS MADE TO RINSE THE IOL, BUT THIS DID NOT RESULT IN ANY IMPROVEMENT, SO THE IOL WAS EXCHANGED FOR COMPANY LENS WITH SAME MODEL AND SAME DIOPTER 15 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. SURGEON ADDED THAT THE EXPLANTED IOL WAS SPLIT IN HALF FOR EXPLANTATION SO THAT NO INCISION WIDENING WAS NECESSARY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING DEFECT WAS A RATHER SUPERFICIAL, SLIGHTLY CURVED ABOUT 3 MILLIMETER LONG, WHICH DID NOT EXTEND ACROSS THE ENTIRE WIDTH OF THE LENS AND WAS RELATIVELY CENTRAL BUT JUST OUTSIDE THE OPTIC CENTER. IMPLANTATION WAS COMPLETELY REGULAR, IMMEDIATELY AFTER IMPLANTATION IT WAS INITIALLY ASSUMED BY THE SURGEON THAT THERE WAS NOT A DEFECT, BUT A VISCOELASTIC OVERLAY, ATTEMPT TO RINSE THE INTRAOCULAR LENS (IOL), THEREFORE IOL WAS NOT EXCHANGED DIRECTLY DURING INITIAL IMPLANTATION, THIS REMAINED WITHOUT IMPROVEMENT. HOWEVER, 7 DAYS POSTOPERATI

  Patient problems: Insufficient Information

  MAUDE report 20856324 ↗
• MalfunctionSep 25, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENSES DID NOT UNFOLD CORRECTLY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE 1 OF 2 FILES.

  Patient problems: Insufficient Information

  MAUDE report 20304815 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR VISION.THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL TWO MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18482195 ↗
• MalfunctionJul 24, 2023Crack; Crack

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, IT WAS REPORTED THAT LENS WAS CRACKED. THE PROCEDURE WAS COMPLETED WITH REPLACEMENT LENS DURING THE INITIAL PROCEDURE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17377838 ↗
• MalfunctionSep 5, 2022Unintended Ejection; Unintended Ejection

  A DOCTOR REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE LENS INSERTED INTO THE CARTRIDGE AND INSERTED WITH THE INJECTOR, THE PLUNGER WAS ADVANCED FORWARD WITH THE FILLED IOL AS USUAL, BUT SUDDENLY THE IOL WAS SHOT OFF FROM THE CARTRIDGE AND WAS INSERTED INTO THE EYE, THE SURGEON TRIED TO INSERT IOL WITH SLOWLY ROTATING THE PLUNGER, BUT IOL WAS INSERTED BEFORE THE LAST PUSH. SINCE IT DID NOT ENTER IN THE BAG WITH ONE ACTION, IT WAS REPOSITIONED WITH A HOOK. THE SURGERY WAS COMPLETED WITHOUT THE PRODUCT REPLACEMENT. LENS WAS STILL IMPLANTED INTO THE PATIENT'S EYE. NO FURTHER INFORMATION AVAILABLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15355518 ↗
• MalfunctionMar 27, 2022Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANT PROCEDURE, A SCRATCH WAS FOUND ON THE IOL OPTIC THAT WAS VISUALLY CONFIRMED. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13925184 ↗