Clareon SY60WF (UDI 00380652251433)Recalls & reported problems
Alcon Laboratories, Inc. · STERILE UV and Blue Light Filtering Acrylic Foldable Aspheric Posterior Chamber Intraocular Lens · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00380652251433), received between Apr 25, 2023 and Jul 15, 2026 — classified as 4 injuries, 14 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break5
- Adverse Event Without Identified Device or Use Problem3
- Defective Device3
- Material Split, Cut or Torn3
- Device Difficult to Setup or Prepare1
- Material Discolored1
- Material Twisted/Bent1
- Product Quality Problem1
Patient problems
- Insufficient Information7
- No Clinical Signs, Symptoms or Conditions7
- Visual Impairment3
- Blurred Vision1
- Eye Irritation1
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT NEAR SIGHT VISION WAS OF THE UTMOST BUT DISTANCE VISION WAS NOT GREAT. THE ONLY CLEAR VISION THAT PATIENT HAD WAS 6 TO 10 FEET. PATIENT WAS WORKING AND FINDING IT VERY DIFFICULT TO SEE. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, PATIENT DID NOT WANT TO WEAR GLASSES UP CLOSE AND HAS APPOINTMENT WITH CURRENT SURGEON AND A SECOND OPINION WAS SCHEDULED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.
Patient problems: Blurred Vision
MAUDE report 25825449 ↗MalfunctionApr 7, 2026Break
A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE TRAILING HAPTIC WAS BROKEN FROM THE LENS. THERE WAS PATIENT CONTACT BUT NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24802297 ↗MalfunctionJan 2, 2026Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED LENS WAS RIPPED. THE LENS WAS NOT IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23943062 ↗MalfunctionDec 29, 2025Break; Break
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TORN OR BROKEN HAPTIC. ADDITIONAL INFORMATION WAS RECEIVED PROCEDURE COMPLETED ON THE SAME DAY AND THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23906833 ↗MalfunctionSep 19, 2025Break; Break
A HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DURING PHACOEMULSIFICATION, PRIOR TO IOL IMPLANTATION, DOCTOR OPENED A LENS, APPLIED VISCOELASTIC ON THE OPTIC, AND USED A COMPANY CARTRIDGE WITH THE COMPANY INJECTOR. WHILE ATTEMPTING IMPLANTATION NEAR THE WOUND, THE PLUNGER FAILED TO ADVANCE FULLY. UPON INSPECTION, THE TRAILING HAPTIC WAS FOUND TO BE DISTORTED AND TORN. THE LENS WAS REMOVED, AND A NEW IOL WAS IMPLANTED USING A DIFFERENT COMPANY INJECTOR. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM TO PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23094402 ↗MalfunctionSep 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, PRIOR TO IOL IMPLANTATION, THE LENS WAS OPENED. AFTER A DROP OF THE COMPANY OPHTHALMIC VISCOSURGICAL DEVICE (OVD) WAS APPLIED ON THE LENS AND INTO THE COMPANY CARTRIDGE, THE SURGEON NOTICED A CRACK AT THE CENTER OF THE LENS WHILE PICKING IT UP BEFORE INSERTING IT INTO THE COMPANY CARTRIDGE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY USING A BACKUP INJECTOR AND THE CONSIGNED LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23092779 ↗InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED LENS POWER CHANGE AND DISCOMFORT. THE IOL WAS EXCHANGED FOR NON-COMPANY LENS 01 MONTH 26 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Eye Irritation; Visual Impairment
MAUDE report 23016602 ↗MalfunctionAug 29, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, FOLLOWING THE INSERTION OF THE INTRAOCULAR LENS (IOL) DURING AN IMPLANT PROCEDURE, THE IOL HAD BEEN LOADED INCORRECTLY. IT WAS CONFIRMED THAT THE LENS MADE CONTACT WITH THE PATIENT, BUT THERE WAS NO REPORTED IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22922272 ↗MalfunctionJul 14, 2025Material Twisted/Bent; Material Twisted/Bent
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, BENT HAPTIC. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22495706 ↗MalfunctionMay 30, 2025Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DAMAGED WITH SCRATCH ON LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22112079 ↗MalfunctionMay 20, 2025Break; Break
ADDITIONAL INFORMATION WAS RECEIVED STATING PROCEDURE WAS COMPLETED WITH COMPANY LENS OF THE SAME POWER.
Patient problems: Insufficient Information
MAUDE report 22051397 ↗InjuryMay 15, 2025Product Quality Problem; Product Quality Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAD POOR VISION. THERE WAS POSTERIOR CHAMBER IOL BOWED. THE LENS WAS EXCHANGED WITH COMPANY SAME MODEL IOL BUT DIFFERENT DIOPTER VALUE AFTER THE INITIAL IMPLANT PROCEDURE. IN THE SURGEONS OPINION DEFECTIVE LENS CAUSED THE EVENT. THE PATIENT'S ISSUE WAS RESOLVED. THE CLINICAL REASON FOR EXPLANT WAS MECHANICAL BREAKDOWN.
Patient problems: Visual Impairment
MAUDE report 22032608 ↗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 223 OF 224.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21925440 ↗InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT'S VISION DID NOT IMPROVE. IT WAS REPORTED THAT DURING SURGERY THE PATIENT JUMPED, SO THE SURGEON HAD TO PLACE A STITCH. THE PATIENT HAD A SECOND OPINION, AND THAT DOCTOR REMOVED THE STITCH HOPING THE VISION WOULD IMPROVE, BUT IT DID NOT. AS PER REPORTER IT WAS NOT SURE IF THE PATIENT HAD A BAD LENS OR SURGEON'S JOB WAS BAD. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 20637939 ↗MalfunctionSep 5, 2024Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn
A NURSE REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) TRAILING HAPTIC TORN OFF AND OPTIC RIPPED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20146752 ↗MalfunctionJul 16, 2024Defective Device; Defective Device
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE LENS WAS DAMAGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19750806 ↗MalfunctionNov 10, 2023Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF DAMAGED INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18109296 ↗MalfunctionApr 25, 2023Defective Device; Defective Device
A NON HEALTH CARE PROFESSIONAL (TEAM LEADER) REPORTED THAT DURING THE INTRAOCULAR LENS (IOL), IMPLANT PROCEDURE LENS FOUND BE A DAMAGED. THERE ARE TWELVE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 5 OF 12. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16807739 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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