Clareon SY60WF (UDI 00380652251372)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 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00380652251372), received between Aug 1, 2022 and Aug 10, 2026 — classified as 4 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (4 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Scratched Material4
- Adverse Event Without Identified Device or Use Problem3
- Break2
- Material Split, Cut or Torn2
- Crack1
- Defective Device1
- Device Damaged by Another Device1
- Failure to Deliver1
Patient problems
- Insufficient Information9
- No Clinical Signs, Symptoms or Conditions4
- Blurred Vision2
- Conjunctivitis2
- Endophthalmitis2
- Hypopyon2
- Corneal Edema1
- Eye Injury1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
InjuryAug 10, 2026Adverse Event Without Identified Device or Use Problem
A non-healthcare professional reported that following a cataract surgery with intraocular lens (IOL) implantation, an elderly patient experienced Toxic Anterior Segment Syndrome (TASS). The surgery was completed on the same day; however, details regarding how the procedure was completed were not provided. The patient's current condition was unknown. It was also stated that there were no plans to remove the lens at the time of the report.
Patient problems: Toxic Anterior Segment Syndrome (TASS)
MAUDE report 50191369 ↗InjuryJul 14, 2026Adverse Event Without Identified Device or Use Problem
A CUSTOMER REPORTED THAT A 79-YEAR-OLD FEMALE PATIENT UNDERWENT PHACOEMULSIFICATION WITH INTRAOCULAR LENS (IOL) IMPLANTATION IN THE RIGHT EYE. DURING A POSTOPERATIVE FOLLOW-UP VISIT, THE PATIENT WAS DIAGNOSED WITH ENDOPHTHALMITIS IN THE RIGHT EYE. CLINICAL EXAMINATION REVEALED ASSOCIATED SIGNS AND SYMPTOMS INCLUDING HYPOPYON, AQUEOUS FIBRIN AND CELLULAR REACTION IN THE ANTERIOR CHAMBER, CORNEAL EDEMA, AND DECREASED VISUAL ACUITY. IN RESPONSE TO THE EVENT, THE PATIENT WAS TREATED WITH INTRAVITREAL ANTIBIOTIC INJECTIONS, STEROIDS, AND NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS). AN ANTERIOR CHAMBER TAP WAS PERFORMED, AND CULTURE RESULTS WERE REPORTED AS NO GROWTH. AT THE TIME OF REPORTING, THE PATIENT HAD NOT RECOVERED.
Patient problems: Blurred Vision; Conjunctivitis; Corneal Edema; Endophthalmitis; Hypopyon
MAUDE report 25812238 ↗MalfunctionMar 26, 2026Material Deformation
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT WITH A DESCRIPTION OF DAMAGED, NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24700331 ↗MalfunctionJan 30, 2026Break; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TORN OR BROKEN HAPTIC ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS DEFECTIVE HAPTIC AND SURGERY COMPLETED ON THE SAME DAY WITH SAME MODEL LENS DURING THE INITIAL PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 24222370 ↗MalfunctionJan 12, 2026Scratched Material
ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT A SCRATCHED LENS WAS NOTICED AFTER LENS WAS IMPLANTED. THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND REPLACED WITH COMPANY LENS. THERE WAS NO PATIENT HARM.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24035275 ↗MalfunctionSep 17, 2025Break; Failure to Deliver; Break; Failure to Deliver
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS GOT STUCK IN BETWEEN THE PLUNGER AND CARTRIDGE AND CAUSED THE TRAILING HAPTIC TO BE BROKEN.
Patient problems: Insufficient Information
MAUDE report 23075479 ↗InjuryAug 28, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A FACILITY REPRESENTATIVE REPORTED VIA FDA MEDWATCH FORM THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN LENS WAS INSERTED INTO EYE, SURGEON SAW THROUGH MICROSCOPE THAT LENS HAD A TEAR. LENS DID NOT APPEAR TO BE DAMAGED UNTIL VIEWED UNDER MICROSCOPE AFTER ALREADY INSERTED IN EYE. THE LENS WAS REMOVED, AND A REPLACEMENT WAS ASKED FOR. THE CIRCULATOR IN THE ROOM WENT TO GET THE REPLACEMENT AND REALIZED THAT THEY DID NOT HAVE A REPLACEMENT ON-SITE. THE SURGEON WAS NOTIFIED, AND SHE SELECTED A LARGER SIZE FOR INSERTION. THE SURGEON HAD TO EXTEND THE INCISION SITE TO MAKE ROOM FOR THE BIGGER LENS. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Eye Injury
MAUDE report 22911474 ↗MalfunctionAug 12, 2025Scratched Material; Scratched Material
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS FOUND TO HAVE SCRATCHED. THE LENS WAS PARTIALLY INSERTED INTO THE EYE AND REMOVED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITHOUT ANY IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22780976 ↗InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD SURGERY ON (B)(6) 2025, AT ONE DAY POST OPERATION THERE WERE NO COMPLAINTS. THE FOLLOWING MORNING THE PATIENT REPORTED PAIN WITH DECREASED VISION IN THE RIGHT EYE. WITH 3+ CONJUNCTIVAL INFLAMMATION, 2+ CELL, AQUEOUS FIBRIN AND HYPOPYON DIAGNOSED AS ENDOPHTHALMITIS. THE PATIENT HAD INTRAVITREAL INJECTION AND WAS REFERRED TO A RETINAL SPECIALIST. NO CULTURES WAS TAKEN.
Patient problems: Blurred Vision; Conjunctivitis; Endophthalmitis; Hypopyon; Inflammation
MAUDE report 22493613 ↗MalfunctionJun 25, 2025Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT WHILE LOADING THE LENS INTO THE CARTRIDGE, THE LENS LOOKED SCRATCHED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22328736 ↗MalfunctionJul 20, 2024Mechanical Jam; Mechanical Jam
A FACILITY REPRESENTATIVE REPORTED THAT DURING SURGERY, THEY NOTICED THAT LENS STUCKED IN INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19786963 ↗MalfunctionDec 7, 2023Failure to Eject; Failure to Eject
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WOULD NOT GO THROUGH CARTRIDGE AND LENS GOT STUCK IN CARTRIDGE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18281624 ↗MalfunctionMay 30, 2023Crack; Scratched Material; Crack; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IOL) IMPLANTATION, THERE WAS ACTUALLY A FLAP OF THE LENS MATERIAL WHERE THE TEAR WAS IN THE IOL, ALONG WITH THE GOUGES. THE LENS WAS REMOVED IN AN INITIAL PROCEDURE. THE REMOVED LENS WAS NOT SAVED. IT WAS ALSO REPORTED THAT THERE WAS NO DAMAGE ON THE LENS FROM VISUAL INSPECTION, PRIOR TO LOADING. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 2. ADDITIONAL INFORMATION RECEIVED STATED THAT THE LENS TORE UPON INSERTION AS ENTERING THE LEFT EYE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17020560 ↗MalfunctionMay 17, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
A FACILITY REPRESENTATIVE REPORTED THAT THE LENS WAS DEFECTIVE, SMALL TEAR ON LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16945789 ↗MalfunctionJan 21, 2023Defective Device; Defective Device
A PHYSICIAN REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT NOTED SMALL DEFECTS ON PERIPHERAL OPTIC. THE IOL WAS REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT DEFECT WAS NOTICED ON THE LENS AFTER INJECTING IT INTO THE EYE. THE HARM TO THE PATIENT IS NOT VISUALLY SIGNIFICANT. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16221252 ↗MalfunctionAug 1, 2022Device Damaged by Another Device; Device Damaged by Another Device
A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, A SCRATCH ON THE OPTIC WAS NOTED. THE SURGERY WAS COMPLETED WITH A REPLACEMENT LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15137421 ↗
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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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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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