TECNIS IOL ZKB00 (REF ZKB00U0060)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS MF 1- PC 6.0MM 6.0D LOW ADD US · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 16, 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 05050474559806), received between Oct 31, 2018 and Oct 31, 2018 — 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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Blurred Vision1
- No Code Available1
- Vitrectomy1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A TECNIS MULTIFOCAL INTRAOCULAR LENS (IOL) MODEL ZKB00, +6.0 DIOPTER WAS EXPLANTED FROM PATIENT¿S RIGHT EYE. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT THE LENS WAS EXPLANTED BECAUSE OF PATIENT EXPERIENCING BLURRY VISION. REPORTEDLY ANTERIOR VITRECTOMY WAS PERFORMED. THE REPLACEMENT LENS WAS AN AR40E +6.5 DIOPTER IOL. POST EXCHANGE THE PATIENT'S VISION WAS WITHIN NORMAL LIMITS. NO FURTHER INFORMATION PROVIDED.
Patient problems: Blurred Vision; No Code Available; Vitrectomy
MAUDE report 8026167 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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