Clareon CNA0T3 (REF CNA0T3.175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652398732), received between Apr 29, 2025 and Nov 11, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Discolored” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2025Material Twisted/Bent; Material Twisted/Bent

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THE HAPTIC WAS BENT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23521602 ↗
• InjuryNov 3, 2025Device Damaged by Another Device; Device Damaged by Another Device

  A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE WHEN THE IOL WAS BEING LOADED THE POSTERIOR LOOP WAS INSERTED AND THEN THE POSTERIOR LOOP WAS TORN. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING WITH THE SAME PRODUCT. ADDITIONAL INFORMATION RECEIVED STATING AS THE INSERTED LENS WAS A TORIC LENS, IT WAS REMOVED IN TO TWO PIECES AND BACKUP LENS WAS IMPLANTED. THE NEXT DAY OF THE SURGERY THE PATIENT WAS EXAMINED WHICH SHOWED A STRONG INFLAMMATION CAUSED DUE TO EXCHANGE OF IOL. TWO DAYS AFTER THE SURGERY IT WAS OBSERVED THAT INFLAMMATION WAS IMPROVING. ADDITIONAL INFORMATION RECEIVED STATING POSTOPERATIVE INFLAMMATION RESOLVED. THE PATIENT WAS TREATED WITH ANTIBACTERIAL EYE DROPS.

  Patient problems: Inflammation

  MAUDE report 23449671 ↗
• MalfunctionApr 29, 2025Material Discolored; Material Discolored

  A PHYSICIAN REPORTED THAT AFTER IMPLANTATION OF LENS DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE IOL LOOKED BLUE IMMEDIATELY. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. IT WAS UNKNOWN WHETHER THESE FINDINGS DISAPPEARED OR CONTINUED. THE LENS REMAINED IMPLANTED. THERE HAVE BEEN NO REPORTED HEALTH PROBLEMS OR HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE. THERE ARE 224 MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS 54 OF 224.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21927521 ↗
• MalfunctionApr 29, 2025Material Discolored; Material Discolored

  A PHYSICIAN REPORTED THAT AFTER IMPLANTATION OF LENS DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE IOL LOOKED BLUE IMMEDIATELY. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. IT WAS UNKNOWN WHETHER THESE FINDINGS DISAPPEARED OR CONTINUED. THE LENS REMAINED IMPLANTED. THERE HAVE BEEN NO REPORTED HEALTH PROBLEMS OR HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE. THERE ARE 224 MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS 15 OF 224.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21927044 ↗