Clareon™ CC60WF (UDI 00380652396929)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
All models of Clareon (1142)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00380652396929), received between Mar 10, 2023 and Aug 26, 2026 — classified as 2 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (3 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
- Material Split, Cut or Torn3
- Scratched Material3
- Adverse Event Without Identified Device or Use Problem2
- Break2
- Crack2
- Appropriate Device Problem Term/Code Not Available1
- Failure to Deliver1
- Material Twisted/Bent1
Patient problems
- Insufficient Information8
- No Clinical Signs, Symptoms or Conditions4
- Corneal Edema2
- Blurred Vision1
- Toxic Anterior Segment Syndrome (TASS)1
- Visual Disturbances1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2026Material Split, Cut or Torn
A non-health care professional reported that during the intraocular lens (IOL) implantation surgery, the lens was cracked. Additional information was received stating that, the lens was inserted and removed during the same procedure and the surgery was completed on the same day using another lens. There was no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50451959 ↗InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS DIAGNOSED WITH TASS (TOXIC ANTERIOR SEGMENT SYNDROME). THE EXACT TIMING AND DETAILS OF THE SURGERY WERE INITIALLY UNKNOWN. THE SURGERY WAS UNEVENTFUL, AND THE PATIENT¿S FIRST POSTOPERATIVE VISIT SHOWED NO PROBLEMS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED THAT THE TASS (TOXIC ANTERIOR SEGMENT SYNDROME) WAS OBSERVED TWO DAYS AFTER THE SURGERY. AT THAT TIME, THE PATIENT ALSO EXPERIENCED CORNEAL EDEMA AND BLURRED VISION. THE PATIENT WAS TREATED WITH TOPICAL MEDICATIONS. THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS FILE IS 2 OF 2.
Patient problems: Blurred Vision; Corneal Edema; Toxic Anterior Segment Syndrome (TASS)
MAUDE report 24923135 ↗MalfunctionApr 16, 2026Failure to Deliver
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF WASTED AND JAMMED LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24904027 ↗MalfunctionApr 15, 2026Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, OBSERVED BROKEN HAPTIC WHEN INSERTED THE LENS. THE LENS WAS REMOVED AND REPLACED WITH SAME MODEL COMPANY LENS OF THE SAME POWER. THE PATIENT HAD NO COMPLICATIONS AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24885245 ↗MalfunctionMar 31, 2026Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE BACK HAPTIC PINCHED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24741836 ↗MalfunctionDec 30, 2025Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED A SCRATCH UPON INSERTING LENS. THE LENS WAS EXCHANGED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED IN THE SURGEON'S OPINION; IT WAS UNSURE WHICH PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23931412 ↗MalfunctionSep 4, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE IOL APPEARED CURLED UPON INSERTION AND CAME OUT IN PIECES WITHIN THE CAPSULAR BAG. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: Insufficient Information
MAUDE report 22963013 ↗InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT SINCE FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLACK ARCS IN VISION. THE IOL WAS EXCHANGED FOR NON-COMPANY LENS MODEL 3 MONTHS 13 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. IN THE SURGEON OPINION THE PRODUCT HAD CAUSED OR CONTRIBUTED TO EVENT. THE PATIENT ISSUE WAS RESOLVED WITH DILATION. IN SURGEON'S PROGNOSIS GOOD POST OPERATIVE APPEARANCE DENIES ARCS WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.
Patient problems: Visual Disturbances
MAUDE report 22216919 ↗MalfunctionApr 30, 2025Material Twisted/Bent; Material Twisted/Bent
A NURSE REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE HAPTIC SHEARED AND TWISTED.
Patient problems: Insufficient Information
MAUDE report 21935881 ↗MalfunctionOct 18, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, UPON PLACING THE IOL, THE SURGEON NOTICED THAT THE LENS WAS CRACKED. THE LENS WAS EXTRACTED AND REPLACED WITH ANOTHER UNSPECIFIED NEW LENS DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20481153 ↗MalfunctionSep 10, 2024Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, IT WAS NOTICED THAT THE LENS HAD A SCRATCH ON IT. ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED, THE LENS WAS REMOVED IN AN INITIAL PROCEDURE. THE SURGERY WAS PERFORMED IN RIGHT EYE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20178576 ↗MalfunctionMar 4, 2024Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON NOTICED SCRATCH ON LENS. THERE WAS PATIENT CONTACT. THE SURGERY WAS COMPLETED THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: Insufficient Information
MAUDE report 18824284 ↗MalfunctionFeb 5, 2024Crack; Crack
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, REPORTED WITH A DESCRIPTION OF LENS CRACKED AFTER BEING LOADED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 18639313 ↗MalfunctionMay 2, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON HAD EXPLANTED THE IOL DURING INITIAL PROCEDURE DUE TO UNUSUAL LARGE VACUOLES IN THE CENTRAL OPTICAL ZONE OF THE LENS. THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16853195 ↗MalfunctionMar 10, 2023Crack; Crack
AN OPHTHALMIC SURGEON REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD A RADIAL CRACK MIDWAY BETWEEN THE HAPTICS THAT INVOLVED THE EDGE OF THE OPTIC WITH JAGGED EDGES WHICH COULD HAVE DAMAGED THE CAPSULE. ADDITIONAL INFORMATION RECEIVED STATED THAT, THERE WAS PROLONGED SURGERY TIME AND MODERATE CORNEAL STROMAL EDEMA WAS DETECTED ON POST OPERATIVE DAY 1.
Patient problems: Corneal Edema
MAUDE report 16521601 ↗
Other intraocular lens devices
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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