TECNIS IOL ZKU300 (REF ZKU300U155)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC LOW ADD 1-PC 15.5D 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 05050474688100), received between Dec 21, 2020 and Dec 21, 2020 — 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.

InjuryDec 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED THE INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO THE PATIENT EXPERIENCING DYSPHOTOPSIA. THERE WAS NO VITRECTOMY, SUTURES, OR INCISION ENLARGEMENT. THE EXPLANTED LENS WAS REPLACED WITH A MODEL#: ZMA00 LENS WITH THE SAME DIOPTER. THE PATIENT OUTCOME IS FINE. PER THE CUSTOMER, NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Code Available; Visual Disturbances
MAUDE report 11052683 ↗

Device details

UDI-DI	`05050474688100`
Brand	TECNIS IOL
Model	ZKU300
Catalog no.	ZKU300U155
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	Jul 8, 2021

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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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