TECNIS IOL DFW300 (REF DFW300U210)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS SYNERGY TORII SMPCY 21.0D CYL3.00 · 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 05050474752467), received between Jun 7, 2022 and Jun 7, 2022 — 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.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1

Patient problems

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.

InjuryJun 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT STARTED TO EXPERIENCE GLARE, HALOS, AND INABILITY TO DRIVE AT NIGHT APPROXIMATELY ONE WEEK AFTER SURGERY IN THEIR LEFT EYE (OS). PATIENT STATUS WAS REPORTED TO BE PERMANENTLY IMPAIRED AND DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. THE INTRAOCULAR LENS (IOL) WAS EXPLANTED IN (B)(6) 2022 DUE TO THE SYMPTOMS THE PATIENT WAS EXPERIENCING. ANOTHER IOL OF DIFFERENT MODEL AND DIOPTER (ZCU150, 24.50) WAS SUCCESSFULLY IMPLANTED. THERE WERE NO UNPLANNED SUTURES, INCISION ENLARGEMENT, OR UNPLANNED VITRECTOMY REQUIRED WHEN REMOVING THE IOL AND NO PATIENT INJURY WAS REPORTED. PRE-OP UNCORRECTED VISUAL ACUITY: 20/60. POST-OP UNCORRECTED VISUAL ACUITY: 20/50. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Halo; Visual Disturbances
MAUDE report 14613251 ↗

Device details

UDI-DI	`05050474752467`
Brand	TECNIS IOL
Model	DFW300
Catalog no.	DFW300U210
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.