Clareon SY60WF (UDI 00380652251594)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00380652251594), received between Jan 4, 2023 and Sep 30, 2026 — classified as 2 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Opacification

  A non-healthcare professional reported after intraocular lens (IOL) implant procedure, the lens is white and cloudy.Additional information was requested and received stating that no subjective symptoms were associated with this finding. No plan for replacing IOL.

  Patient problems: Insufficient Information

  MAUDE report 50948919 ↗
• MalfunctionSep 15, 2026Break; Failure to Fold

  A non-healthcare professional reported that, during an intraocular lens (IOL) implantation procedure, the IOL was observed to be brittle and kinked in the cartridge when advancement was attempted during loading, with no patient contact. The event was attributed to rupture of the leading haptic, as the IOL did not appear to fold correctly. It was further reported that the replacement IOL also appeared unusually brittle; however, it was implanted without incident.Additional information was requested but was not available at the time of this report.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50774465 ↗
• MalfunctionApr 7, 2026Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE WHEN THE IOL WAS BEING INSERTED, THE HAPTIC DID NOT DEPLOY CORRECTLY. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS A PATIENT CONTACT.

  Patient problems: Insufficient Information

  MAUDE report 24801475 ↗
• MalfunctionApr 3, 2026Break; Inaccurate Delivery

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN INSERTING THE IOL, THE LENS WAS EXPELLED FROM THE CARTRIDGE, BUT IT BECAME CAUGHT IN THE INCISION AND COULD NOT FULLY ENTER THE EYE. DURING MANIPULATION, THE TRAILING HAPTIC TORE. THEREFORE, THE LENS WAS EXPLANTED AND REPLACED WITH SAME PRODUCT AND THE SURGERY WAS COMPLETED. THE SURGEON INSERTS IOL BY PLACING THE CARTRIDGE TIP AT THE INCISION WITHOUT ADVANCING IT INTO THE EYE.

  Patient problems: Insufficient Information

  MAUDE report 24778674 ↗
• MalfunctionMar 4, 2026Material Deformation

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LENS FOUND TO BE DAMAGED (NOT USED). ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24510131 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED ENDOPHTHALMITIS. ADDITIONAL INFORMATION STATED THAT CATARACT SURGERY WAS PERFORMED ON (B)(6) 2025 IN THE LEFT EYE. THE PROCEDURE LASTED 7 MINUTES, HAD NO COMPLICATIONS, NO SUTURES, AND WOUND INTEGRITY WAS INTACT. FOR PROPHYLAXIS, A POSTOPERATIVE SUBCONJUNCTIVAL ANTIBIOTIC INJECTION, STEROID, AND NONSTEROIDAL ANTI-INFLAMMATORY DRUG WERE GIVEN. THE PATIENT EXPERIENCED PAIN, BLURRY VISION, REDNESS, AND SWELLING. A DIAGNOSIS OF INFECTIOUS ENDOPHTHALMITIS WAS MADE, WITH VITREOUS INFLAMMATION 3+, CONJUNCTIVAL INFLAMMATION 2+, AQUEOUS CELLS 3+, AND AQUEOUS FIBRIN PRESENT. AND CULTURE WAS NOT DONE. THE ONSET WAS LESS THAN 14 DAYS POSTOPERATIVELY, ON (B)(6) 2025. THE EVENT RESULTED IN CLINICALLY SIGNIFICANT VISUAL CHANGES. THE SURGEON WAS UNSURE WHAT CAUSED OR CONTRIBUTED TO THE EVENT. THE OTHER POTENTIAL CONTRIBUTING FACTORS MENTIONED WAS RETRO PERFORMED IN PRE-OPERATION. ON (B)(6) 2025, THE PATIENT RECEIVED INTRAVITREAL ANTIBIOTIC TREATMENT AND WAS REFERRED TO A RETINAL SPECIALIST. IT WAS UNKNOWN IF THE INTERVENTION WAS EFFECTIVE. THE OUTCOME OF THE EVENT WAS UNKNOWN

  Patient problems: Blurred Vision; Conjunctivitis; Corneal Edema; Endophthalmitis; Eye Infections; Eye Pain; Intraocular Pressure Increased; Iritis; Red Eye(s)

  MAUDE report 23098170 ↗
• MalfunctionSep 10, 2025Inaccurate Delivery; Scratched Material; Inaccurate Delivery; Scratched Material

  A PHARMACIST REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED IMPLANT STUCK IN INCISION DURING PLACEMENT IN THE EYE. THE LENS WAS REMOVED WITH FORCEPS, MARK WAS NOTICED ON THE IMPLANT AND REPLACED WITH NON-COMPANY LENS DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY.

  Patient problems: Insufficient Information

  MAUDE report 23016001 ↗
• MalfunctionJul 28, 2025Scratched Material; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER PHACOEMULSIFICATION AND PRIOR TO IOL IMPLANTATION LENS WAS OPENED. WHEN INSERTING THE LENS, SURGEON SAW THE SCRATCH AT THE SIDE OF THE OPTIC AFTER PUTTING VISCOELASTIC BEFORE PUTTING INTO THE CARTRIDGE. THE LENS WAS NOT INSERTED INTO PATIENT¿S EYE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628404 ↗
• MalfunctionJun 4, 2025Break; Break

  A HEALTHCARE PROFESSIONAL HAD REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION WHEN INSERTING THE LENS IN CARTRIDGE FOUND THAT LENS TRAILING HAPTIC WAS TORN. LENS DID NOT INJECT INTO PATIENT¿S EYE. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON SAME DAY BY USING UNSPECIFIED REPLACEMENT IOL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22140028 ↗
• MalfunctionMay 8, 2025Break; Break

  A HEALTH CARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC ELEMENT WAS TORN OFF. ADDITIONAL INFORMATION RECEIVED AND STATING THAT, ONE PART OF THE HAPTIC BROKE OFF. DURING SURGERY, THE IOL CAME OUT OF THE INJECTOR WITH A DETACHED HAPTIC IN THE PATIENT'S EYEBALL. THERE WAS NO PATIENT HARM AND THE SURGEON REMOVED THE IOL AND HAPTICS AND REIMPLANTED A NEW IOL WITH A DIFFERENT SERIAL NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21985478 ↗
• MalfunctionFeb 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PHYSICIAN REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS BECAME CLOGGED AT THE SCLEROCORNEAL WOUND, THE LENS HAD TO BE REMOVED. A NEW LENS WAS RE-SET, IMPLANTED AND THE SURGERY WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21445079 ↗
• InjuryFeb 18, 2025Adverse 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 EXPERIENCED DIFFICULT IN FOCUSING. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS IMBALANCE BETWEEN EYE AND THE SECOND EYE HAS MEDIAL LONGITUDINAL FASCICULUS (MLF).

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 21398310 ↗
• MalfunctionNov 29, 2024Scratched Material; Scratched Material

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT SCRATCH ON LENS OBSERVED UPON OPENING BEFORE LOADING THE LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20809194 ↗
• MalfunctionOct 31, 2024Material Twisted/Bent; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF THE HAPTIC WAS STUCK UNDER THE INJECTOR¿S PLUNGER DURING DELIVERY OF THE INTRAOCULAR LENS (IOL). THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20576244 ↗
• MalfunctionApr 18, 2024Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS INSERTED INTO EYE AND HAD A SCRATCH ON IT. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19134766 ↗
• MalfunctionFeb 2, 2024Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED STATED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON NOTICED A SCRATCH AFTER IMPLANTATION. SURGEON REMOVED LENS AND PLACED ANOTHER LENS DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18631652 ↗
• MalfunctionDec 11, 2023Defective Device; Defective Device

  A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF DAMAGED INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18302543 ↗
• MalfunctionOct 20, 2023Failure to Eject; Failure to Eject

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS ADVANCED WITH PLUNGER UPSIDE DOWN AND THE DOCTOR WORRIED THAT LENS WAS SCRATCHED DURING SURGERY. THE LENS WAS REMOVED FROM EYE. THERE WAS NO PATIENT HARM. THE ORIGINALLY SCHEDULED PROCEDURE WAS COMPLETED THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17972620 ↗
• MalfunctionSep 11, 2023Crack; Crack

  A NON-HEALTHCARE HEALTHCARE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS CRACKED. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17717375 ↗
• MalfunctionAug 29, 2023Defective Component; Failure to Advance; Defective Component; Failure to Advance

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PROXIMAL HAPTIC BROKE. DURING LENS PROGRESSION IN EYE, THE HAPTIC WAS CAUGHT BY THE INJECTOR AND SPLIT AT THE BASE. IMPLANT ENTERED THE ANTERIOR CHAMBER AND HAD TO BE EXPLANTED BY WIDENING THE INCISION. THE PROCEDURE WAS COMPETED WITH NEW IOL.

  Patient problems: Insufficient Information

  MAUDE report 17641064 ↗
• MalfunctionAug 3, 2023Crack; Crack

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE PHYSICIAN NOTICED TWO LARGE LINEAR CRACKS INVOLVING CENTRAL OPTIC RADIALLY. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN THE SAME PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 17452143 ↗
• MalfunctionMar 15, 2023Failure to Eject; Failure to Eject

  A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HALFWAY THROUGH INSERTION BUT DID NOT RELEASE ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16546474 ↗
• MalfunctionJan 4, 2023Break; Break

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTING PROCEDURE, THE TRAILING HAPTIC WAS FOUND TO BE TORN WHEN IMPLANTED IN THE PATIENT¿S EYE. THE SURGERY WAS COMPLETED AFTER REPLACING THE IOL WITH ANOTHER IOL. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, EXCESSIVE STRAIN ON THE CORNEA CAUSED BY INTRAOCULAR LENS REPLACEMENT RESULTED IN CORNEAL EDEMA. THE WHITE CORNEAL EDEMA HAS GRADUALLY BECOME TRANSPARENT (RECOVERED) AND IS CURRENTLY UNDER OBSERVATION. THE PATIENT COMPLAINS THAT IT IS A LITTLE HARDER TO SEE THAN AFTER THE CATARACT SURGERY FOR ONE EYE. IT IS STILL NOT POSSIBLE TO MEASURE CORNEAL ENDOTHELIAL CELLS. ONCE THE EDEMA IS IMPROVING, THE SURGEON WOULD LIKE TO MEASURE ENDOTHELIAL CELLS AND CONSIDER A FUTURE TREATMENT PLAN.

  Patient problems: Corneal Edema; Visual Impairment

  MAUDE report 16093072 ↗