TECNIS IOL DFW225 (REF DFW225U225)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYNERGY TORII SMPCY 22.5D CYL2.25 · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 05050474751903), received between Jul 31, 2023 and Nov 8, 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
- Halo1
- Visual Disturbances1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO HALOS. NO CAPSULE TEAR, NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE, AND NO PRESCRIBED MEDICATIONS TO PREVENT PERMANENT IMPAIRMENT REQUIRED. REPLACED WITH DIU225, 22.5 DIOPTER POWER SIZE. PATIENT DOING WELL POST-OP. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Halo
MAUDE report 18095170 ↗InjuryJul 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE (OS) DUE TO DYSPHOTOPSIA. THIS WAS REPLACED WITH A NON-JOHNSON AND JOHNSON LENS. EXPLANT PRODUCT ACCIDENTALLY DISCARDED. PATIENT WELL POST-OP. NO OTHER ADVERSE EVENTS REPORTED. PATIENT IOL IN RIGHT EYE WITH HALO AND GLARE HOWEVER NOT REPORTED TO BE DEBILITATING AND NO SECONDARY MEDICAL OR SURGICAL INTERVENTION PERFORMED. DOCTOR WILL SEE HOW THE PATIENT REACTS TO NEW IOL IN OS AND THEN WILL DECIDE ON WHAT TO DO WITH IOL IN OD. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Visual Disturbances
MAUDE report 17431421 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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