Clareon™ CC60WF (UDI 00380652396912)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon™ Aspheric UV Absorbing IOL - STERILE UV-Absorbing Hydrophobic Acrylic Foldable Aspheric Posterior Chamber Intraocular Lens · Class 3 · Implant
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00380652396912), received between Jul 4, 2022 and Jun 2, 2026 — classified as 1 injury, 20 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (11 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Scratched Material11
- Break3
- Defective Device3
- Adverse Event Without Identified Device or Use Problem1
- Crack1
- Material Split, Cut or Torn1
- Material Twisted/Bent1
Patient problems
- Insufficient Information13
- No Clinical Signs, Symptoms or Conditions10
- Blurred Vision1
- Intraocular Pressure Increased1
- Visual Impairment1
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 2, 2026Scratched Material
A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION IN PATIENT'S RIGHT EYE, A SCRATCH WAS OBSERVED ON THE POSTERIOR SIDE OF THE IOL AFTER IT WAS IMPLANTED. THE LENS WAS NOT REMOVED FROM THE EYE, IT REMAINS IMPLANTED. THE SURGERY WAS COMPLETED ON THE SAME DAY AND THERE WAS NO PATIENT HARM. ACCORDING TO THE SURGEON, SOMETHING PHYSICALLY SCRATCHED THE POSTERIOR SIDE OF THE IOL. 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 25362072 ↗MalfunctionMay 27, 2026Scratched Material
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE AT THE TIME OF DELIVERY, THE CENTER OPTIC WAS SCRATCHED. THE IOL WAS SUBSEQUENTLY REMOVED AND REPLACED WITH AN UNSPECIFIED LENS DURING THE INITIAL IMPLANTATION PROCEDURE, WITHOUT ANY ISSUE TO THE PATIENT AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25300550 ↗MalfunctionMay 22, 2026Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT SURGEON NOTICED OPTIC HAD A SCRATCH ONCE LENS WAS INSERTED. THE LENS WAS REMOVED DURING SAME PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND YET NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 25256894 ↗MalfunctionMar 7, 2026Break
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE REPORT WAS ABOUT BENT/BROKEN HAPTIC. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH ANOTHER COMPANY LENS. THERE WAS NO PATIENT HARM.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24539877 ↗MalfunctionFeb 4, 2026Scratched Material
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF SCRATCH ON INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24256256 ↗MalfunctionJan 5, 2026Scratched Material
A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LENS WAS SCRATCHED.
Patient problems: Insufficient Information
MAUDE report 23960315 ↗MalfunctionDec 12, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TRAILING HAPTIC BROKE OFF AND HAD TO BE CUT OUT OF THE EYE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 23787997 ↗MalfunctionDec 8, 2025Break; Break
BASED ON THE ADDITIONAL INFORMATION RECEIVED, THE SURGERY WAS COMPLETED ON THE SAME DAY WITH REMOVAL OF THE INTRAOCULAR LENS (IOL). THE SURGEON WAS UNSURE IF THE PRODUCT CAUSED THE MALFUNCTION. IN SURGEON'S OPINION, IT COULD POSSIBLY BE LOADING ERROR WHICH RESULTED IN BROKEN HAPTIC. THE PROCEDURE WAS PERFORMED ON THE PATIENT¿S LEFT EYE, AND THERE WAS NO PATIENT HARM.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23736981 ↗MalfunctionNov 5, 2025Scratched Material; Scratched Material
AN OPHTHALMIC SURGEON REPORTED THAT DURING IMPLANTATION OF THE INTRAOCULAR LENS (IOL), THEY NOTICED THAT THE DEPLOYMENT WAS A LITTLE TIGHT BUT CONTINUED WITH INJECTING THE LENS. UPON DEPLOYMENT THERE WAS A NOTICEABLE SCRATCH 180 DEGREES APART FROM EACH OTHER ON THE ANTERIOR SURFACE OF THE LENS. THE SURGEON STATED THAT THEY DID NOT NOTICE ANYTHING OUT OF THE ORDINARY DURING THE LENS LOADING BY THE TECHNICIAN. THE DEFECTIVE IOL WAS SUBSEQUENTLY REMOVED AND REPLACED WITH AN IDENTICAL LENS DURING THE SAME PROCEDURE, WITHOUT ANY FURTHER COMPLICATIONS. NEW INFORMATION RECEIVED ON 21-OCT-2025 MENTIONED THAT THE SURGEON BELIEVED THE CARTRIDGE MIGHT HAVE CAUSED THE SCRATCHES ON THE IOL, BASED ON THEIR (POSITION OF SCRATCHES ON THE IOL) POSITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23477681 ↗MalfunctionOct 24, 2025Material Twisted/Bent; Material Twisted/Bent
A FACILITY REPRESENTATIVE REPORTED AS LENS MALFUNCTIONED AND WAS WASTED/NOT USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE IOL WAS MALFORMED WITH ONE HAPTIC CLEARLY LARGER THAN THE OTHER. IT WAS NEVER IMPLANTED INTO THE EYE BECAUSE IT WAS GROSSLY ASYMMETRICAL. ADDITIONAL INFORMATION REQUESTED AND RECEIVED STATING THAT SAMPLE WAS NOT AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23376437 ↗MalfunctionJun 30, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT LENS WAS BROKEN AFTER THE IOL WAS IMPLANTED INTO THE EYE. THERE WAS NO PATIENT INJURY AND HARM. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22357692 ↗MalfunctionJun 20, 2025Scratched Material; Scratched Material
A NURSE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SCRATCH WAS NOTED ON THE OPTIC ONCE IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22298119 ↗MalfunctionFeb 18, 2025Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, OBSERVED SCRATCH IN PARACENTRAL AREA WAS PROBABLY CAUSED BY PLUNGER. ALSO, LENS HAD SCRATCH ON CENTER. THE CARTRIDGE WAS CRACKED. THE IOL WAS EXPLANTED.ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21398836 ↗MalfunctionJun 17, 2024Defective Device; Defective Device
ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT INTRAOCULAR LENS WAS NOTED TO BE DEFORMED WHEN REMOVED FROM CONTAINER. THERE WAS NO PATIENT CONTACT WITH THE DEVICE.
Patient problems: Insufficient Information
MAUDE report 19547005 ↗InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED FILM OVER HER VISION IN THE RIGHT EYE AND SHE CANNOT SEE DISTANCE VERY WELL. THE CUSTOMER ALSO ADDED THAT SHE SAW HER OLD DOCTOR WHO INFORMED HER THAT SHE HAS INCREASED INTRAOCULAR PRESSURE AND PUT HER ON MEDICATION TO REDUCE THE PRESSURE. HE ALSO STATED THAT SHE MIGHT NEED A YAG PROCEDURE.
Patient problems: Blurred Vision; Intraocular Pressure Increased; Visual Impairment
MAUDE report 18824563 ↗MalfunctionAug 14, 2023Crack; Crack
A NURSE REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION A CRACK ON THE OPTIC WAS NOTED AFTER IMPLANTATION INTO THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17541558 ↗MalfunctionMay 23, 2023Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT, THERE WAS DAMAGE OF IOL. THE LENS LEFT IN THE PATIENTS EYE. ADDITIONAL INFORMATION AHS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16983165 ↗MalfunctionMay 23, 2023Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT, THERE WAS DAMAGE OF IOL. THE LENS LEFT IN THE PATIENTS EYE. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 16983015 ↗MalfunctionMar 15, 2023Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT DURING IMPLANTATION OF INTRAOCULAR LENS (IOL), A SIZABLE MARK IN THE MIDDLE OF THE OPTIC ONCE IMPLANTED. SINCE, THE ISSUE WAS NOT ON THE PERIPHERY BUT CLOSER TO THE CENTER OF THE OPTIC, THE LENS WAS RETAINED IN THE EYE AFTER SOME CONSIDERATION. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 16544927 ↗MalfunctionFeb 10, 2023Scratched Material; Scratched Material
A PURCHASING OFFICER REPORTED THAT A SCRATCH ON LENS WAS NOTED AFTER IMPLANTATION DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION.
Patient problems: Insufficient Information
MAUDE report 16353779 ↗MalfunctionJul 4, 2022Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE LENS HAD A SCRATCH ON THE LENS SO COULD NOT BE IMPLANTED AND HAD PATIENT CONTACT, BUT NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14907327 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.