Clareon SY60WF (UDI 00380652251211)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
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652251211), received between Jun 15, 2023 and Feb 11, 2025 — classified as 1 injury, 2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Device Difficult to Setup or Prepare2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Insufficient Information2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blurred Vision1
- Conjunctivitis1
- Endophthalmitis1
- Eye Pain1
- Fibrosis1
- Hypopyon1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 11, 2025Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare
A NURSE HAS BEEN REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, REPORTED THE LOADING ERROR . THE HAPTIC WAS BROKEN DURING INSERTION. THERE WAS PATIENT CONTACT.
Patient problems: Insufficient Information
MAUDE report 21354405 ↗MalfunctionFeb 5, 2025Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE , REPORTED LOADING ERROR . THE HAPTIC WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A NEW IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21311890 ↗InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT AFTER POSTOPERATIVE DAY 14 OF CATARACT SURGERY WITH OPHTHALMIC HANDPIECE, INTRAOCULAR LENS, PHACOEMULSIFICATION TIP, VISCOELASTIC DEVICE AND CONSUMABLE, A 68 YEARS OLD FEMALE PATIENT EXPERIENCED WITH ENDOPHTHALMITIS IN LEFT EYE WITH SYMPTOMS OF EYE PAIN, BLURRY VISION, FLOATER, CONJUNCTIVAL INFLAMMATION WAS <1+, AQUEOUS CELL WAS 3+, AQUEOUS FIBRIN WAS PRESENT WITH HYPOPYON. PATIENT WAS TREATED WITH INTRAVITREAL TAP AND ANTIBIOTICS, CORTICOSTEROIDS MEDICATIONS. CULTURE RESULTS REVEALED NO BACTERIAL GROWTH. CURRENT PATIENT CONDITION WAS UNKNOWN. THIS IS THE REPORT OF PATIENT 1 OF 4.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Conjunctivitis; Endophthalmitis; Eye Pain; Fibrosis; Hypopyon; Vitreous Floaters
MAUDE report 17135126 ↗
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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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