TECNIS IOL ZKU300 (REF ZKU300U250)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC LOW ADD 1-PC 25.0D CYL3.00 · 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 05050474688292), received between Aug 3, 2023 and Aug 3, 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
- Halo1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE MULTIFOCAL NON PRELOADED INTRAOCULAR LENS WAS EXPLANTED DUE TO MULTIFOCAL INTOLERANCE. THE LENS WAS REPLACED WITH NON JNJ LENS. ADDITIONAL INFORMATION WAS RECEIVED THAT REVEALED THAT THE PATIENT HAD INTRACTABLE HALOS DURING MESOPIC CONDITIONS THAT DID NOT IMPROVE WITH TIME. SO DOCTOR HAD TO EXCHANGE THE LENS. THERE WERE NO PATIENT INJURIES AND NO OTHER MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Halo
MAUDE report 17452438 ↗
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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