Clareon SY60WF (UDI 00380652251532)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
Quick summary
This Alcon Clareon SY60WF is a foldable acrylic lens implanted in the eye during cataract surgery. The 67 reports mostly describe lens damage spotted during surgery — scratches, cracks, twisting, or parts breaking, and lenses that would not load into the injector cartridge; several had to be removed and replaced during the same operation, and10 reports involved injuries. No deaths were reported and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 68
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 00380652251532), received between Feb 8, 2022 and Sep 25, 2026 — classified as 10 injuries, 58 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (9 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
- Scratched Material9
- Crack7
- Material Twisted/Bent7
- Adverse Event Without Identified Device or Use Problem6
- Break6
- Defective Device5
- Material Split, Cut or Torn5
- Failure to Eject4
Patient problems
- Insufficient Information32
- No Clinical Signs, Symptoms or Conditions27
- Blurred Vision3
- Endophthalmitis2
- Visual Impairment2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Bacterial Infection1
- Capsular Bag Tear1
Recent adverse event reports
The 25 most recent of 68 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Material Deformation
A physician reported that subsurface nanoglistenings (SSNGs) were observed after intraocular lens implantation surgery. Additional information has been received stating there has been no visual impact to patients at all.There are three Medical Device Reports associated with this report. This is 15 of 29.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899140 ↗MalfunctionJun 26, 2026Device Damaged by Another Device
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, A CRACK WAS OBSERVED WHERE THE INJECTOR MEETS THE LENS. REQUIRED MINIMUM DATASET PROVIDED, NO FURTHER INFORMATION WILL BE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 25635992 ↗MalfunctionJun 5, 2026Material Split, Cut or Torn
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, A CRACK IN THE OPTIC WAS NOTICED AFTER INSERTION, NEEDED CUT AND REMOVED FROM THE EYE. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25412857 ↗MalfunctionApr 21, 2026Product Quality Problem
ADDITIONAL INFORMATION RECEIVED AND IT STATES THAT ONE OF THE HAPTICS WAS FOLDED WHEN OPENED, WITH NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24939415 ↗MalfunctionApr 20, 2026Defective Device
A NON HEALTH CARE PROFESSIONAL REPORTED THAT LENS WAS DEFECTIVE AND COULD NOT BE INSERTED INTO THE CARTRIDGE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24934044 ↗MalfunctionApr 17, 2026Scratched Material
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE DOCTOR NOTICED A SCRATCH AFTER INSERTION. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS ON SAME DAY WITHOUT ANY HARM TO THE PATIENT AND ISSUES WAS RESOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24912007 ↗MalfunctionApr 9, 2026Scratched Material
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT THERE WAS A SCRATCH ON LENS AFTER INSERTION INTO PATIENT'S EYE. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24830057 ↗MalfunctionMar 31, 2026Break; Material Twisted/Bent
A NURSE REPORTED WITH A DESCRIPTION OF BROKEN INTRAOCULAR LENS (IOL) HAPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED LENS HAD AN EXTRA HAPTIC (3RD) WHICH WAS STUCK ON ONE OF THE HAPTICS. IN THE SURGEON¿S OPINION, PRODUCTION ERROR OF LENS CAUSED OR CONTRIBUTED TO THE EVENT. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24743622 ↗MalfunctionMar 18, 2026Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAD BEEN CRACKED. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THERE WAS NO PATIENT CONTACT AND HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24624836 ↗MalfunctionFeb 16, 2026Scratched Material
A NURSE REPORTED AN ISSUE THAT OCCURRED DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE. AFTER THE SURGEON INSERTED THE IOL, HE NOTICED A SCRATCH ON IT. BASED ON NEW INFORMATION PROVIDED, THE REPORTER INDICATED THAT THE PLUNGER FELT TIGHT WHILE ROTATING, WHICH SUGGESTED THAT THE IOL MIGHT NOT BE LOADED PROPERLY. THE REPORTER ALSO MENTIONED THAT THE EXACT ORIENTATION OF THE PLUNGER IS UNKNOWN, BUT IT WAS POSITIONED EITHER ON TOP OR BEHIND THE OPTIC. THE SURGERY WAS COMPLETED BY REMOVING THE LENS IN AND INITIAL PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 24341919 ↗MalfunctionFeb 12, 2026Product Quality Problem
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING ROOT CAUSE OF THE PROBLEM WAS A TECHNICAL ISSUE SPECIFICALLY RELATED TO THE LOADING OF LENSES INTO THE CARTRIDGE WHICH WAS PRIMING OF LENS.
Patient problems: Insufficient Information
MAUDE report 24321541 ↗MalfunctionFeb 10, 2026Product Quality Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DEFECTIVE AND NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24307339 ↗MalfunctionJan 12, 2026Failure to Fold; Inaccurate Delivery
A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LENS DID NOT SLIDE PROPERLY. HENCE THE LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 24039864 ↗MalfunctionDec 26, 2025Device Damaged Prior to Use; Scratched Material; Device Damaged Prior to Use; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, OBSERVED SCRATCH AT THE CENTRE OF THE LENS WHEN PICKING UP THE LENS BEFORE INSERTING IT INTO CARTRIDGE. THE SURGEON CHANGED TO ANOTHER BACKUP INJECTOR AND BACKUP CONSIGNED LENS. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23895993 ↗MalfunctionNov 26, 2025Break; Break
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS BROKEN. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23655086 ↗InjuryNov 7, 2025Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT DURING THE INTRAOCULAR LENS IMPLANT PROCEDURE, WHEN LENS WAS INSERTED, A SCRATCH WAS FOUND ON THE ROOT OF ITS HAPTIC THEN POSTERIOR CAPSULE WAS DAMAGED. LENS WAS REPLACED WITH NON-COMPANY LENS WITHOUT ANY ISSUE. HOWEVER, WHEN IT SPREAD SCRATCHES AT THE ROOT OF ITS OPTIC WERE FOUND. THEN, POSTERIOR CAPSULE WAS DAMAGED. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT DAMAGE TO THE POSTERIOR CAPSULE OCCURRED AFTER LENS INSERTION. THE ROOT OF THE HAPTIC APPEARS TO BE BROKEN. THE SURGEON MENTIONED THAT THE EDGE OF THE BROKEN HAPTIC MAY HAVE RUBBED AGAINST THE POSTERIOR CAPSULE, WHICH COULD BE THE CAUSE OF THE DAMAGE.
Patient problems: Capsular Bag Tear
MAUDE report 23496905 ↗MalfunctionOct 22, 2025Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS SCRATCHED IN THE DELIVERY SYSTEM. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23357365 ↗MalfunctionSep 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A CRACK APPEARED ON THE IOL SURFACE DURING INSERTION. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. THE LENS REMAINED IN THE PATIENT'S EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23094889 ↗InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT UNABLE TO SEE CLEARLY. THE LENS WAS EXPLANTED AND REPLACED WITH OTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS UNABLE TO SEE CLEARLY AT INTERMEDIATE. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: Blurred Vision
MAUDE report 23094515 ↗InjurySep 10, 2025Particulates; Particulates
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED FOREIGN BODY SENSATION. CLINICAL REASON FOR EXPLANT WAS METAL EMBEDDED IN LENS. THE IOL WAS EXCHANGED FOR SAME MODEL, SAME DIOPTER, SAME COMPANY LENS 14 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE PATIENT WAS NOT HOSPITALIZED AS A RESULT OF THIS EVENT. IN THE SURGEON'S OPINION, THE PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THE EVENT AS PER SURGEON'S METAL EMBEDDED IN LENS. THE PATIENT'S ISSUES WERE RESOLVED. SURGEON'S PROGNOSIS WAS GOOD. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING POSSIBLY REMNANTS LEFT ON THE LENS.
Patient problems: Foreign Body Sensation in Eye
MAUDE report 23016587 ↗MalfunctionJul 29, 2025Break; Break
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS BROKEN WHEN THE LENS WAS INJECTED INTO THE PATIENT EYE FROM CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22648830 ↗MalfunctionJun 26, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS(IOL) IMPLANT PROCEDURE THE LENS GOT TWISTED I THE COMPANY INJECTOR. THE SURGERY WAS COMPLETED WITH ANOTHER LENS ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THERE WAS NO PATIENT CONTACT AND NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22335745 ↗MalfunctionMay 21, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, WHILE ADVANCING THE IOL INTO THE EYE, THE INSERTION ROD DID NOT ENGAGE THE IOL EDGE PROPERLY TO PUSH THE IOL THROUGH THE CARTRIDGE AND THE ROD ROAD ABOVE THE IOL. THE PHYSICIAN ATTEMPTED TO RETRACT THE ROD AND ADVANCE THE IOL FOR THE SECOND TIME, BUT THE SAME THING HAPPENED. THE CARTRIDGE WAS ENGAGED WITH THE EYE AND THE IOL REMAINED WITHIN THE CARTRIDGE. SO, THE PHYSICIAN DECIDED TO GET A NEW IOL, CARTRIDGE AND HANDPIECE AND DELIVERED THE IOL INTO THE EYE SUCCESSFULLY. AS PER THE PHYSICIAN THE MORE ROUNDED EDGE OF THE IOL DID NOT ENGAGE WITH THE STANDARD HANDPIECE ADVANCEMENT ROD.
Patient problems: Insufficient Information
MAUDE report 22062335 ↗MalfunctionMay 14, 2025Material Deformation; Material Deformation
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DAMAGED ON INSERTION. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 22018222 ↗MalfunctionMay 13, 2025Material Twisted/Bent; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS REMAINS BENT IN THE INJECTOR WHILE LOADING. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22008677 ↗
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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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