Clareon SY60WF (UDI 00380652251648)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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652251648), received between Sep 26, 2022 and Jan 22, 2026 — classified as 1 injury, 5 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
- Crack1
- Device Difficult to Setup or Prepare1
- Failure to Deliver1
- Material Twisted/Bent1
- Scratched Material1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions3
- Eye Injury1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 22, 2026Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS JAMMED IN CARTRIDGE WHILE TRYING TO IMPLANT INTO PATIENT. THE BACKUP LENS WAS IMPLANTED SUCCESSFULLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24147879 ↗MalfunctionJan 16, 2026Material Twisted/Bent
A PHARMACIST REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, OBSERVED DAMAGED HAPTICS. THE SURGERY COMPLETED SAME DAY. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24093333 ↗MalfunctionFeb 26, 2025Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS LOADING ISSUE WAS NOTICED. CUSTOMER WAS ASKING IF IT WAS THE CARTRIDGE. REPORTED BOTH HAPTIC WAS RIPPED OFF AND CARTRIDGE WAS CRACKED. ADDITIONAL INFORMATION HAS BEEN RECEIVED, THE REPORTER CALLED AND SAID IT WAS A NEWER SCRUB TECH ASSISTING THE SURGEON, WHO TOOK LONGER THAN USUAL FOR THE IRRIGATION AND ASPIRATION (I AND A). REPORTER BELIEVED THAT THE LENS WAS LOADED TOO LONG BEFORE NEWER SCRUB TECH AND SURGEON TRIED TO INJECT IT. THE BACKUP LENS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM. ALSO MENTIONED THE LENS WAS QUITE THICK AND MAYBE A DIFFERENT MODEL, COMPANY CARTRIDGE SHOULD HAVE BEEN USED. THERE WAS NO ADDITIONAL INFORMATION, AND THE PRODUCT WAS DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21468589 ↗MalfunctionFeb 18, 2025Break; Break
A NON-HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION, HAPTIC WAS BROKEN AND THE INTRAOCULAR LENS (IOL) WAS WASTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21392200 ↗MalfunctionJul 12, 2024Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT DURING SURGERY, THREE LENSES WERE SCRATCHED. IT WAS NOTICED DURING IMPLANTATION OF THE LENS AND ONE OF THE LENSES HAD TO BE EXPLANTED. THERE WAS PATIENT CONTACT HOWEVER NO PATIENT HARM. SAMPLE HAS BEEN DISCARDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH ANOTHER MODEL OF THE COMPANY LENS. THERE ARE THREE MEDICAL REPORTS ASSOCIATED WITH THIS EVENT. TWO OF THE REPORTS WERE BILATERAL AND THIS FILE BELONGS TO RIGHT EYE OF A SEPARATE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19728559 ↗InjurySep 26, 2022Crack; Crack
A NON HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE LENS WAS NOTICED CRACKED. THERE WAS PATIENT CONTACT AND THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Eye Injury; Insufficient Information
MAUDE report 15485215 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page