TECNIS IOL ZMA00 (REF ZMA00U0245)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS MF 3- PIECE 6.0MM 24.5 US · Class 3 · Implant

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 05050474536890), received between Apr 7, 2022 and Apr 7, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

Device Dislodged or Dislocated1

Patient problems

Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Blurred Vision1
Visual Disturbances1

Recent adverse event reports

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

InjuryApr 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE RIGHT EYE DUE TO "FOGGY AND DISTORTED AND DISLOCATED" LENS. ANOTHER JOHNSON & JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIFFERENT MODEL AND DIFFERENT DIOPTER, AR40E 22.0D). THERE WAS NO PATIENT INJURY AND NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT IS STABLE POST-OPERATIVELY. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE IOL DISLOCATION WAS NOT DUE TO DEVICE MALFUNCTION, HOWEVER, NO FURTHER INFORMATION WAS AVAILABLE TO CLARIFY THE EVENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Visual Disturbances
MAUDE report 14048766 ↗

Device details

UDI-DI	`05050474536890`
Brand	TECNIS IOL
Model	ZMA00
Catalog no.	ZMA00U0245
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.