Clareon SY60WF (UDI 00380652251396)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 00380652251396), received between Apr 25, 2023 and May 7, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Defective Device” (1 report).
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
- Defective Device1
- Device Damaged by Another Device1
- Failure to Deliver1
- Material Deformation1
- Material Split, Cut or Torn1
- Material Twisted/Bent1
- Scratched Material1
Patient problems
- Insufficient Information4
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2026Failure to Deliver; Device Damaged by Another Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THERE WAS INJECTOR PROBLEM - THE LENS WAS JAMMED INTO THE INJECTOR AND WAS SCRATCHED. CONSEQUENTLY, THE LENS WAS REMOVED AND REPLACED WITH A SAME MODEL AND DIOPTER VALUE COMPANY LENS IN AN INITIAL PROCEDURE. BASED ON THE NEWLY RECEIVED INFORMATION, THE SCHEDULED PROCEDURE WAS PHACOEMULSIFICATION WITH INTRAOCULAR LENS IMPLANTATION. ACCORDING TO THE SURGEON¿S ASSESSMENT, THE LENS WAS LIKELY SCRATCHED DURING THE LOADING PROCESS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25109308 ↗MalfunctionJan 2, 2026Material Deformation
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, POSSIBLE DEFECT ON THE LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23943573 ↗MalfunctionJun 20, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NURSE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, INTRAOCULAR LENS (IOL) BROKE WHEN IMPLANTING. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE LENS WAS FOLDED AND INSERTED INTO THE EYE AND THE LENS WAS THEN DISCOVERED TO HAVE BROKEN INTO THREE PIECES AND NEEDED TO BE EXPLANTED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY.
Patient problems: Insufficient Information
MAUDE report 22300009 ↗MalfunctionMay 28, 2025Scratched Material; Scratched Material
A NON HEALTH CARE PROFESSION REPORTED VIA MEDWATCH FORM THAT, DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER IMPLANTATION IOL FOUND TO HAVE SCRATCH AND IT HAS BEEN IMMEDIATELY EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 22096210 ↗MalfunctionJan 17, 2025Material Twisted/Bent; Material Twisted/Bent
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAS DEFECT IN THE HAPTIC PART AT THE ATTACHMENT TO THE OPTIC. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21177399 ↗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 1 OF 12. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16807517 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- 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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