Clareon SY60WF (UDI 00380652251655)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
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652251655), received between Nov 25, 2022 and Jul 27, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (3 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 Material3
- Defective Device2
- Break1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 27, 2026Scratched Material
Patient problems: Insufficient Information
MAUDE report 50033906 ↗MalfunctionMay 21, 2026Scratched Material
A NURSE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS SCRATCHED WHEN THE HAPTICS UNFOLDED, THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25242440 ↗MalfunctionMay 15, 2026Break
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE HAPTIC WAS TORN OR BROKEN. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED, STATING THAT THE HAPTIC WAS TORN UPON IMPLANTATION OF THE IOL WITH PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25185310 ↗MalfunctionAug 8, 2024Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE LENS WAS INSERTED INTO THE EYE AND HAD A DEFECT ON THE LENS. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE AND GOT A NEW ONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING LENS WAS INSERTED INTO EYE AND HAD A SCRATCH REMOVED GOT A NEW ONE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT. THE PATIENT ISSUES WERE RESOLVED AND SURGEON'S PROGNOSIS WAS GREAT AND AS PER SURGEON'S OPINION IOL CAUSED THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19938779 ↗MalfunctionDec 13, 2022Defective Device; Defective Device
A NON HEALTH CARE PROFESSIONAL REPORTED THAT THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS INSERTED IN EYE AND A DEFECT WAS NOTED IN THE CENTER OF THE LENS. LENS REMOVED AND NEW LENS PLACED. ADDITIONAL INFORMATION WILL BE REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15967336 ↗MalfunctionNov 25, 2022Defective Device; Defective Device
A NURSE REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THERE WAS A DEFECT IN THE MIDDLE OF THE LENS WITH PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED PATIENT DETAILS.
Patient problems: Insufficient Information
MAUDE report 15864650 ↗
Other intraocular lens devices
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 reports
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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