Clareon™ CC60WF (UDI 00380652396905)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
Quick summary
This Alcon Clareon CC60WF is a foldable artificial lens implanted in the eye during cataract surgery. The 27 reports mostly describe cosmetic and handling problems noticed during surgery — scratches, splits or tears in the lens material, small dents in the optic, and haptics that would not fold or advance properly — with lenses sometimes removed and replaced. There are no deaths and no injuries, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00380652396905), received between Dec 29, 2022 and Sep 24, 2026 — classified as 1 injury, 29 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (12 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 Material12
- Break4
- Material Split, Cut or Torn4
- Failure to Deliver3
- Product Quality Problem3
- Defective Device2
- Material Twisted/Bent2
- Dent in Material1
Patient problems
- Insufficient Information17
- No Clinical Signs, Symptoms or Conditions14
- Visual Impairment1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Scratched Material
A non health care professional reported that during an intraocular lens (IOL) implant procedure, scratch on the lens was noticed. Additional information has been requested and received stating that the lens was inserted and removed during initial procedure. The surgery was completed on same day without any harm to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884541 ↗MalfunctionSep 18, 2026Failure to Deliver; Scratched Material
A non-healthcare professional reported that, during an intraocular lens (IOL) implantation procedure, the lens would not advance fully into the eye. It then became scratched while attempts were made to remove and reload it.Additional information has been requested and received by stating there was no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50814630 ↗InjuryAug 7, 2026Device Dislodged or Dislocated
A nonhealth care professional reported that after the intraocular lens (IOL) implantation surgery, the patient experienced poor vision. Hence the lens was explanted and replaced with another lens of same company in a secondary procedure. The clinical reason for explant was malposition of the lens, incorrect power and refractive error.
Patient problems: Visual Impairment
MAUDE report 50171605 ↗MalfunctionJun 23, 2026Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, OBSERVED A SCRATCH ON LENSES. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE LENS WAS INSERTED AND REMOVED DURING THE INITIAL PROCEDURE AND WAS COMPLETED ON THE SAME DAY WITHOUT ANY IMPACT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25596814 ↗MalfunctionMay 6, 2026Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED SCRATCH AFTER THE IOL WAS PLACED IN THE PATIENT'S EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND YET NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 25091361 ↗MalfunctionApr 24, 2026Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, IT WAS NOTED THAT THE IOL HAD MARK ON IT. THERE WAS NO PATIENT CONTACT. 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 24977118 ↗MalfunctionApr 20, 2026Product Quality Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED VIA REPLY CARD AS DEFECTIVE WASTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24927292 ↗MalfunctionMar 17, 2026Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT A DEFECT IN THE OPTICAL ZONE OF THE INTRAOCULAR LENS (IOL) WAS OBSERVED DURING IOL IMPLANTATION SURGERY. THE LENS WAS REMOVED AND REPLACED WITH A NEW LENS IN AN INITIAL PROCEDURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION CLARIFIED THAT THE DEFECT IN THE OPTICAL ZONE WAS A SCRATCH ON THE OPTIC. THE REPLACEMENT IOL WAS A COMPANY LENS OF THE SAME MODEL AND DIOPTER VALUE. THE SURGERY WAS PERFORMED IN THE PATIENT'S RIGHT EYE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24614661 ↗MalfunctionFeb 6, 2026Dent in Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SMALL DIVOT DEFECTS WERE OBSERVED ON THE POSTERIOR OPTIC. AN ATTEMPT WAS MADE TO POLISH THEM OFF WITHOUT SUCCESS AND THE IOL REMAINED IN THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE 3 OF 3 FILES.
Patient problems: Insufficient Information
MAUDE report 24277237 ↗MalfunctionFeb 5, 2026Product Quality Problem; Material Twisted/Bent
AN ACCOUNT MANAGER REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANT SURGERY SURGEON FOUND THE HAPTIC WOULD NOT FOLD IN PROPERLY AND ADVANCE INTO THE CARTRIDGE AND ALSO LENS DEFECTIVE.
Patient problems: Insufficient Information
MAUDE report 24267059 ↗MalfunctionJan 12, 2026Material Twisted/Bent; Scratched Material
A PHYSICIAN REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED DIG ALONG THE HAPTICS. THE PROCEDURE WAS COMPLETED ON THE SAME DAY, AND THE IOL REMAINED IMPLANTED IN THE EYE ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24036255 ↗MalfunctionJan 2, 2026Break
ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE HAPTIC GOT CAUGHT WHEN INJECTING IN EYE CAUSING IT TO SHEAR. THE LENS WAS INSERTED AND REMOVED DURING INITIAL PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23942498 ↗MalfunctionDec 30, 2025Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS SCRATCHED CENTRALLY. THE LENS WAS EXCHANGED AND REPLACED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23931413 ↗MalfunctionDec 16, 2025Product Quality Problem; Product Quality Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, OBSERVED DEFECTIVE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23815736 ↗MalfunctionNov 11, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS LOADED AND WOULD NOT COME OUT OF THE CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23521975 ↗MalfunctionSep 19, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED HAPTIC WAS BROKEN AFTER THE IOL WAS IMPLANTED INTO THE EYE. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23095171 ↗MalfunctionSep 4, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS OPTIC WAS BROKEN OR CRACKED AFTER IMPLANTATION. THE LENS WAS REMOVED FROM THE PATIENT EYE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22962793 ↗MalfunctionAug 13, 2025Failure to Deliver; Failure to Deliver
A NON HEALTH CARE PROFESSIONAL REPORTED AN UNSPECIFIED ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE LENS WAS IN THE CARTRIDGE BUT WAS STUCK AND WOULD NOT MOVE.
Patient problems: Insufficient Information
MAUDE report 22795252 ↗MalfunctionMay 30, 2025Break; Break
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS BROKEN. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22112671 ↗MalfunctionMar 24, 2025Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, OBSERVED MARK ON CENTER OF LENS. THE LENS WAS REMOVED AND REPLACED DURING INITIAL PROCEDURE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21679368 ↗MalfunctionMar 14, 2025Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS INSERTED INTO EYE AND HAPTIC BROKE OFF. THE LENS WAS THEN EXPLANTED AND THE HAPTIC RETRIEVED FROM THE EYE AND IT WAS REPLACED WITH ANOTHER LENS DURING THE SAME PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21604156 ↗MalfunctionFeb 18, 2025Device Difficult to Setup or Prepare; Material Split, Cut or Torn; Device Difficult to Setup or Prepare; Material Split, Cut or Torn
A NURSE REPORTED THAT DURING SURGERY, THEY HAVE NOTICED THAT CRACKS ON THE OUTER DIAMETER OF THE OPTICS WERE OBSERVED UPON IMPLANTATION. DOCTOR DIDN¿T FEEL THESE WOULD IMPACT THE PATIENT¿S VISION AND OPTED NOT TO EXPLANT THIS LENS. ALSO, STATES THAT FELT SOME ADDITIONAL RESISTANCE WHEN IMPLANTING THIS LENS. HE SAID THE TACTILE FEEL OF ADVANCING THE LENS INTO THE EYE VIA THE INSERTER FELT LIKE IT REQUIRED A LITTLE MORE FORCE THAN NORMAL. ADDITIONAL INFORMATION HAS RECEIVED SCHEDULED PROCEDURE COMPLETED ON THE SAME DAY.
Patient problems: Insufficient Information
MAUDE report 21403275 ↗MalfunctionJul 10, 2024Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS DEFECTIVE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19709228 ↗MalfunctionMar 19, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS LOADED AND INJECTED INTO THE PATIENT EYE. IT WAS OBSERVED THAT LENS ON THE LEFT SIDE WAS SPLIT BY THE HAPTIC ALSO THERE WAS A CRACK ON THE RIGHT SIDE IN TWO AREAS. THE LENS WAS EXPLANTED IN THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED NEW LENS WAS IMPLANTED AND THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18928339 ↗MalfunctionFeb 13, 2024Defective Device; Defective Device
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE INTRAOCULAR LENS HAD DEFECT IN THE CENTER. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18694084 ↗
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.