Clareon SY60WF (UDI 00380652251358)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652251358), received between Sep 27, 2022 and May 14, 2026 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Break

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, LENS HAPTIC WAS BROKEN AND IT WAS WASTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 25171320 ↗
• InjurySep 12, 2025Particulates; Adverse Event Without Identified Device or Use Problem; Particulates; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT VISITED SURGEON¿S OFFICE 30 HOURS LATER AND WHEN THE TECH EXAMINED THE TECH REMOVED A ¿COVER¿ FROM THE INSERTED LENS OR THE EYE WITH A TWEEZER AND EXPRESSED SOME SURPRISE THAT IT WAS STILL ON THE IMPLANT. THE PATIENT ALSO REPORTED THAT RIGHT EYE WAS COMPROMISED (UNSPECIFIED). ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 23035790 ↗
• MalfunctionJul 25, 2025Dent in Material; Dent in Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THAT THE LENS WAS DEFECTIVE AND THE LENS WAS OPENED AND NOT IMPLANTED. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION RECEIVED AND STATED THAT WHEN LENS WAS INSERTED INTO THE EYE, THERE WAS A VERY LARGE CREASE OBSERVED DOWN THE CENTER OF THE LENS AND LENS WAS THEN CUT OUT AND A REPLACEMENT LENS WAS PLACED IT WAS STATED THAT IN SURGEON'S OPINION ISSUE WITH FOLDING CAUSED THE EVENT, PROCEDURE WAS COMPLETED ON THE SAME DAY WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22609177 ↗
• MalfunctionMar 26, 2025Break; Break

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER INJECTING THE LENS INTO THE EYE, THE SURGEON OBSERVED HAPTIC WAS BROKEN. THE LENS WAS REMOVED AND REPLACED DURING THE INITIAL PROCEDURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21699665 ↗
• InjuryMar 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A NURSE REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS GOT STUCK AT THE INCISION SITE. THE SURGEON WAS UNABLE TO ADVANCE THE LENS IN THE EYE. THE SURGEON HAD TO MAKE LARGER INCISION TO REMOVE THE LENS AND REPLACE IT WITH A NEW ONE. AS PER THE SURGEON THE PROGNOSIS OF THE PATIENT WAS STABLE.

  Patient problems: Insufficient Information

  MAUDE report 21696540 ↗
• InjuryAug 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM CONSUMER. ACCORDING TO CONSUMER, THE VISION AND COMFORT WERE NOT BETTER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Dry Eye(s); Foreign Body Sensation in Eye

  MAUDE report 17470345 ↗
• MalfunctionSep 27, 2022Defective Device; Material Split, Cut or Torn; Defective Device; Material Split, Cut or Torn

  A PHYSICIAN REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS FOUND TO BE TORN WHEN THE LENS WAS IMPLANTED DURING SURGERY. THE LENS WITH THE TORN HAPTIC WAS EXPLANTED AND REPLACED WITH A NEW IOL, AND THE SURGERY WAS COMPLETED. ADDITIONAL INFORMATION WAS RECEIVED STATING PATIENT EXPERIENCED CORNEAL EDEMA.

  Patient problems: Corneal Edema

  MAUDE report 15495544 ↗