TECNIS IOL ZKB00 (REF ZKB00U0295)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS MF 1- PC 6.0MM 29.5D LOW ADD US · 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 05050474560277), received between Jan 25, 2017 and Jan 25, 2017 — 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
- No Code Available1
- Visual Disturbances1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER IMPLANTATION OF A ZKB00 INTRAOCULAR LENTS (IOL) THE PATIENT IS SEEING A HORIZONTAL LINE RUNNING THROUGH HIS VISION IN BOTH EYES. THE PATIENT ALSO HAS SIGNIFICANT GLARE IN BOTH EYES DESCRIBED AS HORIZONTAL GLARE THAT IS NOT TOLERABLE. THE PHYSICIAN PERFORMED A YTTRIUM-ALUMINUM-GARNET LASER (YAG) IN THE LEFT EYE; HOWEVER THIS DID NOT RESOLVE THE ISSUE COMPLETELY. HE NOTED THAT THE PATIENT WILL STILL HAVE THE ISSUE IN THE RIGHT EYE, SO HE PLANS TO PERFORM A LENS EXCHANGE ON THE RIGHT EYE. THE LENS REMAINS IMPLANTED AND WILL BE REPLACED WITH A NON-AMO MONOFOCAL DEVICE. THERE WERE NO PATIENT INJURY REPORTED FOR THIS EVENT. THE PHYSICIAN ALSO NOTED THAT THE PATIENT HAS A POSTERIOR CAPSULE OPACIFICATION (PCO) ON THE LEFT EYE ALSO BUT EXCHANGING THE LENS AFTER A YAG IS MORE CHALLENGING AND RISKY. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE PATIENT'S RIGHT EYE. AND A SEPARATE REPORT WILL BE FILED FOR THE LENS IMPLANTED IN THE PATIENT'S LEFT EYE.
Patient problems: No Code Available; Visual Disturbances
MAUDE report 6278045 ↗
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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