TECNIS IOL DFR00V (REF DFR00VU095)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS SYNERGY SIMPLICITY 09.5D · 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 05050474750463), received between May 17, 2024 and May 17, 2024 — 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1

Patient problems

Blurred Vision1
Halo1
Visual Disturbances1

Recent adverse event reports

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

InjuryMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE MULTIFOCAL INTRAOCULAR LENS(IOL) HAD SIGNIFICANT GLARE AND HALO CAME FROM A LIGHT SOURCE. THE PATIENT HAD TO CLOSE AND/OR SQUINT THEIR LEFT EYE TO SEE BETTER. IT WAS FIRST REPORTED TO THE SURGEON ON (B)(6) 2021, DURING A POST-OP VISIT, AND HE KEPT COMING BACK WITH THE SAME COMPLAINT. SYMPTOMS SIGNIFICANTLY INTERFERE WITH THE PATIENT¿S DAILY ACTIVITIES. LENS WAS REPLACED WITH ANOTHER COMPANY IOL. PRE-OP UNCORRECTED AND BEST CORRECTED VISUAL ACUITY WAS -0.75 +0.25 X180 20/40 UC 20/40 BC, AND POST-OP BEST CORRECTED VISUAL ACUITY WAS -1.75+0.50 X060 20/40. POST-PROCEDURE, THE PATIENT IS DOING WELL. THERE WAS NO INJURY, AND SURGICAL AND MEDICAL INTERVENTIONS WERE REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Blurred Vision; Halo; Visual Disturbances
MAUDE report 19347542 ↗

Device details

UDI-DI	`05050474750463`
Brand	TECNIS IOL
Model	DFR00V
Catalog no.	DFR00VU095
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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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.