TECNIS IOL DFW225 (REF DFW225U090)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS SYNERGY TORII SMPCY 09.0D CYL2.25 · 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 05050474751637), received between Sep 24, 2021 and Sep 24, 2021 — 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

Discomfort1

Recent adverse event reports

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

InjurySep 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD ISSUES WITH THE SYNERGY INTRAOCULAR LENS (IOL). AN EXCHANGE WAS PERFORMED BILATERALLY. THROUGH FOLLOW-UP, THE CUSTOMER CLARIFIED THAT THE AFFECTED EYE WAS THE RIGHT EYE. THE REASON FOR THE EXPLANT IS THAT THE PATIENT WAS OFF TARGET AND UNHAPPY WITH THE OUTCOME. THEIR VISION PRE-OPERATIVE ON (B)(6) 2021 WAS 20/100 AND POST-OPERATIVE IN (B)(6) 2021 WAS 20/60. THE CUSTOMER ALSO EXPLAINED THAT THE INCISION WAS NOT ENLARGED, NO VITRECTOMY AND NO SUTURES WERE REQUIRED. THERE WAS NO DELAY IN PROCEDURE. MEDICATION WAS PRESCRIBED, BUT THERE'S NO INDICATION THAT THEY WERE NOT PART OF THE REGULAR MEDICAL REGIMEN. ADDITIONALLY, IT WAS EXPLAINED THAT THE SYMPTOMS PERSISTED FOR ABOUT 1 MONTH. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Discomfort
MAUDE report 12530583 ↗

Device details

UDI-DI	`05050474751637`
Brand	TECNIS IOL
Model	DFW225
Catalog no.	DFW225U090
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.