Clareon CNW0T4 (UDI 00380652410199)Recalls & reported problems
Alcon Laboratories, Inc. · CLAREON BLF TORIC · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380652410199), received between Sep 27, 2022 and Sep 8, 2026 — classified as 2 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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
- Material Split, Cut or Torn4
- Break2
- Material Discolored2
- Device Contamination with Chemical or Other Material1
- Device Difficult to Setup or Prepare1
- Malposition of Device1
- Scratched Material1
Patient problems
- Insufficient Information5
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50671193 ↗MalfunctionSep 8, 2026Break; Material Split, Cut or Torn
A non-healthcare professional reported that, during intraocular lens implantation surgery, the lenses had cracks upon being loaded & inserted into the eye. The cases were completed and there was no patient harm. Additional information has been requested and received stating that the first lens was implanted into the eye using the loader. Upon insertion, a crack was observed in the middle of the optic. Based on this observation, the surgeon decided to explant the lens during initial procedure. A second lens was then implanted using the loader; however, a very small non-central crack was noted, and the haptic was trailing. Additionally, the bulb on the haptic became caught in the inserter and twisted beneath the injector. Despite multiple attempts to release it, the distal portion of the haptic broke off. Consequently, this lens was also explanted during initial procedure. A third unspecified lens was subsequently implanted without any issues. The procedure was completed the same day.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50671190 ↗MalfunctionApr 29, 2025Material Discolored; Material Discolored
A PHYSICIAN REPORTED THAT AFTER IMPLANTATION OF LENS DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE IOL LOOKED BLUE IMMEDIATELY. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. IT WAS UNKNOWN WHETHER THESE FINDINGS DISAPPEARED OR CONTINUED. THE LENS REMAINED IMPLANTED. THERE HAVE BEEN NO REPORTED HEALTH PROBLEMS OR HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE. THERE ARE 224 MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS 34 OF 224.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21925843 ↗InjuryMar 19, 2025Break; Break
PHYSICIAN REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE POSTERIOR HAPTIC OF THE INTRAOCULAR LENS WAS PRESUMABLY DAMAGED (CUT) BY THE PLUNGER OF THE COMPANY INJECTOR DURING IMPLANTATION. IT WAS STATED THE DAMAGED IOL WAS CUT AND REMOVED AND A SIMILAR IOL WAS IMPLANTED THE FOLLOWING DAY WITHOUT ANY COMPLICATIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21640334 ↗MalfunctionFeb 10, 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 DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED LOADING ERROR AND THE LENS CRACKED DURING INSERTION. THE PROCEDURE WAS COMPLETED WITH A NEW LENS. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21342281 ↗MalfunctionFeb 5, 2025Material Discolored; Material Discolored
A PHYSICIAN REPORTED THAT THE PROBLEM WAS THE IOL COATING. ON THE FIRST OPERATIVE DAY ONE, THE LENS SEEMED BLUE AT A MEDICAL EXAMINATION. THE LENS REMAINED IN THE PATIENT'S EYE. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT, AS OF ONE WEEK AFTER THE SURGERY, THE LENS FINDING WAS STILL CONTINUING.
Patient problems: Insufficient Information
MAUDE report 21312618 ↗MalfunctionJun 6, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS IN FRAGMENTS/PIECES AFTER IMPLANTATION. THE SURGEON CUT THE LENS OUT AND SAFELY IMPLANTED A NEW ONE DURING INITIAL PROCEDURE. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THERE WAS NO PATIENT HARM REPORTED TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17070368 ↗InjuryJun 6, 2023Malposition of Device; Malposition of Device
A PHYSICIAN REPORTED THAT FOLLOWING AN A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IMPLANT TURNED AT D7 CONTROL. THE IMPLANT TURNED FROM 107 DEGREES TO ABOUT 160/170 DEGREES. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED, STATING THE IMPLANT WAS PLACED IN THE RIGHT AXIS AT THE TIME OF INJECTION. AFTER SEVEN DAYS OF IMPLANTATION, THE IOL WAS REPOSITIONED CORRECTLY IN RE-INTERVENTION.
Patient problems: Insufficient Information
MAUDE report 17069731 ↗MalfunctionOct 27, 2022Scratched Material; Scratched Material
A NURSE REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE INSERTED THE LENS AND THEN NOTICED THE SCRATCH, IMMEDIATELY REMOVED IT. PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15681679 ↗MalfunctionSep 27, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A PHYSICIAN REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PIGMENT ADHESION WAS CONFIRMED DURING POSTOPERATIVE EXAMINATION. THE CUSTOMER CONSIDERED THAT THE PIGMENT DERIVED FROM THE IRIS AND WAS CONSIDERED NOT INFLAMMATORY, THE INVOLVEMENT OF THE COMPANY LENS MATERIAL WAS SUSPECTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15493011 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page