TECNIS IOL DFW225 (REF DFW225U200)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYNERGY TORII SMPCY 20.0D 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 05050474751859), received between May 31, 2022 and Jul 12, 2022 — 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Flashers1
- 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.
InjuryJul 12, 2022Adverse 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 DUE TO ISSUES WITH BRIGHT LIGHTS, GLARE. THE PATIENT HAD DIFFICULTY READING, WATCHING TV, AND SEEING ROAD SIGNS AT NIGHT. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES REQUIRED. ANOTHER JOHNSON & JOHNSON LENS, MODEL DIU225 20.0 DIOPTER WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS DOING WELL WITH NO REPORTED COMPLICATIONS. THE SUSPECT PRODUCT IS NOT BEING RETURNED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Visual Disturbances
MAUDE report 14993731 ↗InjuryMay 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED AN INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). POST-OPERATIVELY PATIENT COMPLAINED OF FLICKERS OF LIGHT, HALOS, AND DIFFICULTY DRIVING AT NIGHT. THE IOL WAS EXPLANTED AND REPLACED WITH ANOTHER JOHNSON & JOHNSON LENS ZCU225 23.0 DIOPTER LENS. PATIENT STATUS WAS REPORTED AS PERMANENTLY IMPAIRED. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING NO UNPLANNED INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO UNPLANNED SUTURE(S), AND NO UNPLANNED VITRECTOMY WERE REQUIRED. PATIENT STATUS POST-LENS EXCHANGE REPORTED AS BLURRY VISION, BUT IMPROVEMENT WEEK 1 VS. DAY 1. PATIENT IS NO LONGER PERMANENTLY IMPAIRED AFTER LENS EXCHANGE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Flashers; Halo
MAUDE report 14553303 ↗
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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