TECNIS IOL ZKU225 (REF ZKU225U200)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC LOW ADD 1-PC 20.0D 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474687615), received between Jan 17, 2023 and Jan 17, 2023 — classified as 1 injury.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Blurred Vision1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WILL BE EXCHANGED FROM ZKU TO A DIU ON A POST REFRACTIVE PATIENT. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE LEFT EYE (OS) EXPLANT IS SCHEDULED FOR (B)(6) 2022, DUE TO THE PATIENT BEING UNHAPPY DUE TO BLURRY VISION. THE PLAN IS TO IMPLANT ANOTHER JOHNSON AND JOHNSON IOL (DIFFERENT MODEL, DIU150, DIFFERENT DIOPTER OF 19.5) USING ORA. THERE ARE NO SURGICAL COMPLICATIONS. ADDITIONAL INFORMATION WAS RECEIVED ON DEC 20, 2022 THAT THE DEVICE WAS RETURNED FOR EVALUATION, INDICATING THAT THE IOL HAD BEEN EXPLANTED DURING A SECONDARY PROCEDURE. THROUGH ADDITIONAL FOLLOW-UP, IT WAS LEARNED THAT THE LENS WAS EXPLANTED ON (B)(6) 2022. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIFFERENT MODEL, DIU150, DIFFERENT DIOPTER, 19.5). NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED AND THERE WAS NO PATIENT INJURY. ON DAY ONE POST-OPERATIVE ((B)(6) 2022), THE PATIENT'S UNCORRECTED VISUAL ACUITY OS WAS 20/50. ON (B)(6) 2022, THE PATIENT UNCORRECTED VISUAL ACUITY OS WAS 20/60, PINHOLE (PH) 20/40. THE DOCTOR REQUESTED THAT THE PATIENT RETURN TO THE CLINIC IN THREE WEEKS. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision
MAUDE report 16184757 ↗
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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