TECNIS IOL ZKB00 (REF ZKB00U0110)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS MF 1- PC 6.0MM 11.0D 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474559905), received between Apr 3, 2017 and Jul 17, 2017 — classified as 2 injuries.
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 Problem2
Patient problems
- No Code Available2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A REPORT WAS RECEIVED THAT A TECNIS 1 MULTIFOCAL MODEL ZKBOO INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S OPERATIVE EYE AS THERE WAS A HYPEROPIC MISS. THE INITIAL IOL WAS REPLACED WITH A ZMB IOL MODEL. NO ADDITIONAL INFORMATION IS PROVIDED.
Patient problems: No Code Available
MAUDE report 6719779 ↗InjuryApr 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A ZKB00 11.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A MALE PATIENT'S RIGHT EYE DUE TO PATIENT EXPERIENCING DEBILITATING GLARE DURING DAY AND NIGHT. THE LENS WAS REPLACED WITH A MONOFOCAL, MODEL ZCB00 11.5 DIOPTER IOL. THERE WAS NO VITRECTOMY REQUIRED. HOWEVER INCISION ENLARGEMENT WAS NEED TO MAKE THE LENS EXCHANGE POSSIBLE. THROUGH FOLLOW-UP IT WAS LEARNED THAT THE LENS HAD BEEN DISCARDED.
Patient problems: No Code Available
MAUDE report 6455261 ↗
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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