TECNIS IOL ZKU225 (REF ZKU225U140)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC LOW ADD 1-PC 14.0D CYL2.25 · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474687493), received between Oct 8, 2023 and Oct 8, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Delivered as Unsterile Product1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 8, 2023Break; Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem; Break; Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THE ZKU225 MODEL INTRAOCULAR LENS (IOL) WAS RECEIVED IN A SEALED LENS BOX WITH NO DAMAGE AND NO TRANSIT DAMAGE. WHEN CARTON WAS OPENED THE CASSETTE SEAL APPEARED QUESTIONABLE AND ACCOUNT WAS CONCERNED STERILITY MAY HAVE BEEN COMPROMISED. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED STATING THE PRODUCT WAS OPENED UPON RECEIVING IN SHIPMENT AND IT NEVER MADE IT TO ANY PROCEDURE OR ANYWHERE NEAR AN OPERATING ROOM (OR); THEREFORE NO PATIENT CONTACT. THE EXTERIOR SHIPPING BOX WAS IN PRISTINE CONDITION HOWEVER, WHEN OPENING THE SHIPPING BOX AND TAKING THE CARTRIDGE OUT, THE SEAL ON THE CARTRIDGE WAS ALREADY CUT INTO AND CARTRIDGE WAS DAMAGED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17892720 ↗
Other Lens, multifocal intraocular devices
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular144 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular1 recall66 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular113 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular112 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular110 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular107 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular104 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular93 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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