Clareon CNW0T5 (UDI 00380652410731)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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652410731), received between Jun 26, 2026 and Sep 9, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Opacification” (1 report).
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 Opacification1
- Material Split, Cut or Torn1
Patient problems
- Blurred Vision1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2026Material Opacification
A surgeon reported that after an intraocular lens (IOL) implant procedure, surgeon noticed a film of haze on the surface of the IOL during post operative day 1.Additional information was requested and received stating the lens was not explanted and still retained in eye.Additional information was requested and received stating the surgeon confirmed that patient vision worsens and has scheduled for an explant.Additional information was requested and received stating the lens was explanted and replaced with same model company lens.
Patient problems: Blurred Vision
MAUDE report 50693676 ↗MalfunctionJun 26, 2026Material Split, Cut or Torn
A NURSE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, AFTER THE IMPLANTATION, DURING THE SURGERY, THE SURGEON NOTICED THE LENS WAS CRACKED. HENCE THE LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25637723 ↗
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.
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