Clareon SY60WF (UDI 00380652251426)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
- 18
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00380652251426), received between May 24, 2022 and Sep 25, 2026 — classified as 2 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Break” (6 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
- Break6
- Scratched Material5
- Defective Device2
- Material Split, Cut or Torn2
- Crack1
- Device Damaged by Another Device1
- Device Dislodged or Dislocated1
- Failure to Deliver1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- Insufficient Information9
- Eye Injury1
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Scratched Material
A health care professional reported that, during intraocular lens implantation surgery, it was found scratch on the optic under microscope and there was no patient harm.Additional information has been requested but is not available at the time of this report.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893365 ↗MalfunctionAug 24, 2026Material Split, Cut or Torn
A non-healthcare professional reported that during an intraocular lens (IOL) implant procedure, lens was cracked. Additional information has been requested and received by stating there was no patient contact and harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50408591 ↗InjuryJul 8, 2026Scratched Material
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LOADING ERROR WAS NOTICED. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE LENS WAS SCRATCHED. THE LENS WAS REMOVED WITH LENS SCISSORS. THE INCISION WAS WIDENED AND 10 NYLON WAS USED TO CLOSE THE INCISION. THERE WAS NO FURTHER PATIENT IMPACT.
Patient problems: Eye Injury
MAUDE report 25744553 ↗MalfunctionMay 22, 2026Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE LENS FOUND TO BE DAMAGED. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE LENS WAS NOT DEPLOYING PROPERLY. THE SURGERY WAS COMPLETED ON THE SAME DAY. THE LENS WAS NOT INSERTED IN TO THE PATIENT EYE. THE LENS REMAIN IN THE DELIVERY SYSTEM. PER THE SURGEON¿S OPINION IT WAS EITHER LENS DEFECT OR TECHNICIAN LOADING ISSUE. THERE WAS A NO IMPACT TO THE PATIENT. THE SURGEONS PROGNOSIS WAS GOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25255970 ↗MalfunctionMay 18, 2026Break; Product Quality Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DEFECTIVE. THERE WAS A PATIENT CONTACT, AND THE LENS WAS NOT USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25203160 ↗MalfunctionDec 30, 2025Device Damaged by Another Device; Device Damaged by Another Device
A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE IT WAS OBSERVED THAT THE INJECTOR PLUNGER COULD NOT ADVANCE THE FOLDED IOL THROUGH THE NARROW SECTION OF THE CARTRIDGE. THIS LED TO A CARTRIDGE CRACK AND SUBSEQUENT DAMAGE TO THE IOL. ON THE SAME DAY THE PATIENT WAS IMPLANTED WITH ANOTHER IDENTICAL IOL. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE SURGEON ASSUMES THAT SOMETHING WAS WRONG WITH THE LENS, PREVIOUSLY THERE WERE NO ISSUES.
Patient problems: Insufficient Information
MAUDE report 23922799 ↗MalfunctionSep 18, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED A TORN OR BROKEN HAPTIC. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23082909 ↗MalfunctionJul 11, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TRAILING HAPTIC BROKE AND THE LENS HAD TO BE CUT OUT OF PATIENT'S EYE IN ORDER TO REPLACE. THE PROCEDURE WAS COMPLETED ON SAME DAY.
Patient problems: Insufficient Information
MAUDE report 22487839 ↗MalfunctionJan 27, 2025Break; Break
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS BROKEN BEFORE USE. ADDITIONAL INFORMATION RECEIVED STATING THAT HAPTIC BROKEN WHILE LOADING THE LENS. THE PROCEDURE COMPLETED THE SAME DAY WITH NEW LENS. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21240714 ↗MalfunctionSep 26, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS TORE UPON IMPLANTATION. THE LENS WAS REMOVED AND ANOTHER LENS WAS IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED, THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20308364 ↗MalfunctionSep 5, 2024Break; Scratched Material; Break; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS INDENTED AND TORN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20146569 ↗MalfunctionMar 19, 2024Crack; Crack
A CONSUMER REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, ONCE LENS IN THE EYE, UNDER THE MICROSCOPE SURGEON COULD SEE SEVERAL LITTLE CRACKS. HE HAD TO CUT OUT AND REMOVE THE IMPLANT AND INSERT A NEW ONE WITH NO PATIENT HARM. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18929712 ↗MalfunctionJan 5, 2024Scratched Material; Scratched Material
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS DEFECTIVE NOTED UPON IMPLANTATION. LENS WAS EXPLANTED AT INITIAL PROCEDURE AND REPLACED WITH UNSPECIFIED LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THE LENS HAD SCRATCHES. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18452139 ↗MalfunctionNov 23, 2023Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS FOUND TO BE BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18198116 ↗InjuryJul 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
A REGISTERED NURSE REPORTED ABOUT A LENS BEING EXPLANTED IN A SECONDARY PROCEDURE DUE TO LENS WHEN CHECKED POST OPERATIVELY FOUND TO BE DECENTERED. THE LENS WAS REPLACED WITH NON COMPANY LENS.
Patient problems: Insufficient Information
MAUDE report 17390313 ↗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 3 OF 12. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16807518 ↗MalfunctionApr 25, 2023Defective Device; Defective Device
A NON HEALTH CARE PROFESSIONAL (TEAM LEADER) REPORTED THAT DURING THE INTRAOCULAR LENS (IOL), LENS FOUND BE A DAMAGED. THERE ARE TWELVE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 12.
Patient problems: Insufficient Information
MAUDE report 16807506 ↗MalfunctionMay 24, 2022Scratched Material; Scratched Material
AN OPHTHALMOLOGIST REPORTED THAT, FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, OPTIC OF THE IOL FOUND TO BE SCRATCHED. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. ADDITIONAL INFORMATION WAS RECEIVED THAT, AFTER INSERTION OF THE IOL, A VERTICAL WHITE OPACITY WAS OBSERVED ON THE POSTERIOR SURFACE OF THE IOL. THE IOL WAS REMOVED IN THREE SECTIONS AND A SPARE IOL WAS INSERTED WITH THE SAME INJECTOR AND A DIFFERENT CARTRIDGE. THE PATIENT'S POSTOPERATIVE COURSE WAS GOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14485657 ↗
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- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
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- 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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