Clareon™ CC60WF (UDI 00380652396752)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 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652396752), received between May 23, 2023 and May 28, 2026 — classified as 1 injury, 7 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Adverse Event Without Identified Device or Use Problem1
- Defective Device1
- Device Difficult to Setup or Prepare1
- Failure to Unfold or Unwrap1
- Material Split, Cut or Torn1
- Material Twisted/Bent1
- Product Quality Problem1
Patient problems
- Insufficient Information4
- No Clinical Signs, Symptoms or Conditions3
- Capsular Bag Tear1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 28, 2026Device Difficult to Setup or Prepare; Material Twisted/Bent
A NURSE REPORTED A LOADING ERROR DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE LENS/HAPTIC STUCK IN CARTRIDGE. THERE WAS NO PATIENT CONTACT AS IT WAS NOTED DURING LOADING. PROCEDURE WAS COMPLETED ON THE SAME DAY. IN THE SURGEONS OPINION, LOADING ERROR CAUSED OR CONTRIBUTED TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25323376 ↗MalfunctionApr 29, 2026Product Quality Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED DURING SURGERY LENS WAS MALFUNCTION AND REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 25028386 ↗MalfunctionMar 24, 2026Break
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, FRONT HAPTIC WAS KINKED IN CARTRIDGE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24672667 ↗InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED CAPSULAR TEAR REQUIRING LENS TO BE CUT OUT AND REMOVED. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THERE WAS NO PATIENT HARM.
Patient problems: Capsular Bag Tear
MAUDE report 23277846 ↗MalfunctionJul 18, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NURSE REPORTED THAT DURING THE INTRAOCULAR LENS IMPLANT PROCEDURE THERE WERE TWO SMALL CRACKS OBSERVED IN THE INTRAOCULAR LENS (IOL) AFTER IMPLANTATION. ONE AT EACH HAPTIC AND SURGEON CHOSE TO LEAVE IN PLACE AND DISCUSS WITH PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22543290 ↗MalfunctionMay 13, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, UPON LENS INSERTION INTO EYE, DOCTOR NOTICED LEADING HAPTIC BROKEN OFF/MISSING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT STARTED PUTTING LENS INTO CARTRIDGE SURGEON NOTICED MISSING HAPTIC BEFORE CONTACT WITH PATIENT EYE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITH A BACK UP IOL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22014677 ↗MalfunctionNov 14, 2024Failure to Unfold or Unwrap; Scratched Material; Failure to Unfold or Unwrap; Scratched Material
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, HAPTIC WAS STUCK TO THE LENS ONCE THAT WAS UNSTUCK THE DOCTOR NOTICED THE NICK IN THE LENS. DOCTOR USES THESE LENS 6 TO 7 TIMES A MONTH. THE WAS NO PATIENT CONTACT AND NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20681478 ↗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 16982956 ↗
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 13, 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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