TECNIS IOL DFW225 (REF DFW225U205)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYNERGY TORII SMPCY 20.5D CYL2.25 · Class 3 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474751866), received between Sep 16, 2022 and Oct 4, 2023 — classified as 2 injuries.
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
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Blurred Vision1
- Discomfort1
- Flashers1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT IS REPORTED THAT NON PRELOADED MULTIFOCAL INTRAOCULAR LENS WAS EXPLANTED FROM PATIENT'S EYE DUE TO DYSPHOTOPSIA AND UNHAPPY DISTANCE VISION. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Flashers; Visual Disturbances; Visual Impairment
MAUDE report 17871909 ↗InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE DFW225 20.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). DFW225 IOL WAS EXPLANTED AND REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION LENS DUE TO COMPLAINTS OF SUBOPTIMAL BEST CORRECTED VISUAL ACUITY (BCVA), BLURRED VISION, AND DIFFICULTLY SEEING DISTANT AND CLOSE OBJECTS. IT WAS REPORTED DAILY ACTIVITIES ARE SIGNIFICANTLY AFFECTED AND THE PATIENT IS A PILOT. THERE WAS NO INCISION ENLARGEMENT, NO SUTURE(S), AND NO VITRECTOMY. PATIENT WAS PRESCRIBED KETORALAC, PREFORTE AND GATIFLOXACIN WHICH WAS CONFIRMED TO BE PATIENT STANDARD CARE. IT WAS CONFIRMED PATIENT DAILY ACTIVITIES ARE NO LONGER SIGNIFICANTLY AFFECTED AFTER DFW225 EXPLANT. PATIENT STATUS WAS REPORTED AS FULLY RECOVERED AND PATIENT IS HAPPY WITH THE SURGERY. IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Blurred Vision; Discomfort
MAUDE report 15440843 ↗
Other Lens, multifocal intraocular devices
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular144 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular1 recall66 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular113 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular112 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular110 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular107 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular104 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular93 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.