TECNIS IOL DFW375 (REF DFW375U205)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS SYNERGY TORII SMPCY 20.5D CYL3.75 · 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 05050474753044), received between Jun 15, 2022 and Jun 15, 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 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PATIENT COMPLAINED OF HALOS, GLARE, AND INABILITY TO DRIVE AT NIGHT WITH AN INTRAOCULAR LENS (IOL) POST-OPERATIVE (OP) MONTH 3. VISION PRE-OPERATIVE: 20/60 VISION POST-OPERATIVE: 20/60. PATIENT STATUS WAS REPORTED TO BE PERMANENTLY IMPAIRED AND DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. EXPLANT WAS PLANNED, BUT HAD NOT OCCURRED. THROUGH FOLLOW-UP, IT WAS LEARNED THE LENS WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. ANOTHER JOHNSON & JOHNSON ZCU375 LENS (DIFFERENT MODEL AND 22.5 DIOPTER) WAS SUCCESSFULLY IMPLANTED AS A REPLACEMENT. THE EXPLANTED LENS WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Halo; Visual Disturbances
MAUDE report 14692315 ↗

Device details

UDI-DI	`05050474753044`
Brand	TECNIS IOL
Model	DFW375
Catalog no.	DFW375U205
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.