Clareon SY60WF (UDI 00380652251402)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380652251402), received between Aug 26, 2022 and Aug 12, 2026 — classified as 4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Failure to Deliver

  Patient problems: Insufficient Information

  MAUDE report 50218960 ↗
• MalfunctionFeb 14, 2026Material Deformation

  A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF DAMAGED INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE LENS WAS DAMAGED UPON INSERTING.

  Patient problems: Insufficient Information

  MAUDE report 24340724 ↗
• MalfunctionJan 13, 2026Break

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TORN OR BROKEN HAPTIC, MISSING PART OF HAPTIC. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24052722 ↗
• MalfunctionAug 20, 2024Scratched Material; Scratched Material

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON NOTICED A SCRATCH IN THE MIDDLE OF LENS. LENS WAS EXPLANTED IN INITIAL PROCEDURE.THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20008726 ↗
• MalfunctionMar 15, 2024Crack; Crack

  A PHYSICIAN REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A CRACK WAS FOUND IN THE IOL OPTIC. THE LENS WAS REMOVED DURING THE INITIAL PROCEDURE, AND REPLACED WITH ANOTHER LENS. THE EYE INVOLVED AND THE PATIENT IDENTIFIER WERE NOT AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18911687 ↗
• MalfunctionFeb 13, 2024Defective Device; Defective Device

  A NURSE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THEY IMPLANTED AN IOL THAT HAD TORIC MARKING DOTS BUT WAS NOT A TORIC LENS. THE LENS WAS REMOVED IN AN INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED. IN THE SURGEON'S OPINION, THE IOL WAS DEFECTIVE. THE SURGEON REMOVED THE IOL ONCE IT WAS IMPLANTED AND REPLACED WITH ANOTHER IOL IN SAME PROCEDURE. THERE WAS NO PATIENT HARM, PATIENT'S ISSUES WERE RESOLVED AFTER REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18693931 ↗
• InjuryFeb 9, 2024Material Deformation; Material Deformation

  A SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT LENS HAD GLISTENING AND OPACITY THAT MAY REQUIRE EXPLANTATION. THE SURGEON WILL SEE THE PATIENT AGAIN THE FOLLOWING WEEK. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED LENS EXPLANTATION HAS BE DECIDED, BUT NOT DONE YET. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED LENS EXPLANTATION HAS BE DONE. QUANTIFICATION OF THE GLISTENING (TYNDALL ANALOGY) SHOWED 3+ CONSTANT OVER TIME, BUT LESS PERIPHERAL OPACIFICATION ON EXPLANTATION 1+ AND THE SAME FOR HAPTICS.

  Patient problems: Insufficient Information

  MAUDE report 18675032 ↗
• InjurySep 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COMPLAINED OF NEAR VISION NOT GOOD ENOUGH. CLINICAL REASON BEING MECHANICAL COMPLICATION OF LENS. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN MONOFOCAL LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 17780426 ↗
• InjuryAug 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, CONSUMER HAD DECREASED VISION (FELT IT DECREASED BY 20%), SANDY SENSATION, IRRITATION/SCRATCHES IN THE EYES. CONSUMER WAS UNHAPPY WITH THE RESULTS, HAD DRY EYES AND WAS TOLD TO USE PRESERVATIVE FREE ARTIFICIAL TEARS DROPS, USING THEM 5 TIMES A DAY FOR DRY EYES. AGE-RELATED MACULAR DEGENERATION (ARMD) IN THE CONSUMER BEGAN. THE VISION COULD NOT GET ANY BETTER THAN 20/80 EVEN AFTER FOLLOW-UP. CONSUMER BELIEVED THE LENSES MIGHT BE WRONG POWER FOR THE EYES, AND THEY MIGHT BE TOO BIG OR WRONG SIZE FOR THE EYES. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER'S SURGEON. THE SURGEON STATED THAT THE PATIENT (CONSUMER) COMPLAINED OF DECREASED UNCORRECTED NEAR VISION. HOWEVER, ACCORDING TO THE SURGEON, IT WAS A NORMAL OUTCOME OF A STANDARD LENS THAT WAS CONSISTENT WITH PATIENT'S REFRACTION AND THE CONSUMER (PATIENT) HAD UNREALISTIC EXPECTATION OF SURGICAL OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED FROM CONSUMER. ACCORDING TO CONSUMER, THE SYMPTOMS WERE NOT IMPROVED. EYE WAS AS IRRITATED AS DAY OF SURGERY AND WAS USING DROPS 6-8 TIMES A DAY. VISUAL ACUITY FLUCTUATED ALL DAY LONG. CONSUMER COULD READ WORDS WHILE WATCHI

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

  MAUDE report 17470231 ↗
• MalfunctionMar 21, 2023Defective Device; Defective Device

  A LEAD OPHTHALMIC NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LARGE CHIP ON RIM WAS NOTED. THE LENS WAS LEFT IN POSITION AND WAS NOT EXPLANTED. DEFECT WAS OBSERVED BUT DETERMINED NOT TO BE OF VISUAL SIGNIFICANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16585206 ↗
• InjuryAug 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING A CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT PROCEDURE, IOL WAS REPLACED WITH ANOTHER LENS DUE TO POSTOPERATIVE REFRACTION ERROR AND PATIENT'S VISION WAS POOR. THE SURGEON CONSIDERS THAT LENS WAS NOT THE CAUSE OF THE POSTOPERATIVE REFRACTION ERROR, AND THAT IT WAS A CLOSE-TO-SPECIAL CASE OF LASIK EYE WITH THE CORNEA SCRAPED TO 32.0D. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 15302882 ↗