TECNIS IOL ZKB00 (REF ZKB00U0275)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS MF 1- PC 6.0MM 27.5D 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 05050474560239), received between Sep 26, 2016 and Sep 26, 2016 — 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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjurySep 26, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN INTRAOCULAR LENS, MODEL ZKB00, WAS EXPLANTED DUE TO BLURRY VISION AND THAT THE PATIENT HAD DIFFICULTY ADJUSTING TO THE LENS. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES DONE. ADDITIONALLY, THERE WAS NO PATIENT POST-OP INJURY. THE PATIENT WAS REPORTED AS DOING FINE.
Patient problems: Blurred Vision; No Code Available
MAUDE report 5978491 ↗

Device details

UDI-DI	`05050474560239`
Brand	TECNIS IOL
Model	ZKB00
Catalog no.	ZKB00U0275
Company	Johnson & Johnson Surgical Vision, Inc.
Product code	MFK · LENS, MULTIFOCAL INTRAOCULAR
Class	Class 3
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 22, 2022

Device type (GMDN): Posterior-chamber intraocular lens, pseudophakic

An optical device, generally referred to as an intraocular lens (IOL), intended to be implanted permanently in the posterior chamber of the eye (ring-like space filled with aqueous humor between the iris, the crystalline lens, and the ciliary body) to replace the natural lens (crystalline lens), typically because it has been clouded by a cataract. The device is made of a synthetic material (e.g., plastic, hydrogel). Included may be a sterile, single-use, IOL injector into which this device is preloaded and ready for insertion into the eye. Disposable devices associated with implantation (e.g., IOL injector) may be included with the lens.

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All LENS, MULTIFOCAL INTRAOCULAR devices →

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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