TECNIS IOL DFW225 (REF DFW225U130)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYNERGY TORII SMPCY 13.0D 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474751712), received between Nov 9, 2021 and Nov 15, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Device Difficult to Setup or Prepare1
- Material Split, Cut or Torn1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 15, 2022Device Difficult to Setup or Prepare; Mechanical Jam; Material Split, Cut or Torn; Device Difficult to Setup or Prepare; Mechanical Jam; Material Split, Cut or Torn
IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) CAME OUT RIPPED. THERE WAS PATIENT CONTACT. THROUGH FOLLOW-UP IT WAS LEARNED THERE WAS NO USE ERROR AND OVD WAS USED. THE LENS INITIALLY MOVED A LITTLE WHEN TRYING TO ADVANCE AND THEN STUCK. THERE WAS NO DELAY IN SURGERY BEFORE AN ATTEMPT TO ADVANCE THE LENS. THERE WAS PATIENT CONTACT WITH THE PATIENT'S LEFT EYE. SURGICAL TIME WAS LONGER BECAUSE "THE FIRST LENS" NEEDED TO BE CUT AND REMOVED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15795802 ↗MalfunctionNov 9, 2021Break; Break
IT WAS REPORTED THAT PRELOADED LENS (IOL) WAS DEFECTIVE. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION STATES LENS HAPTIC OR OPTIC GOT DAMAGED BY THE PLUNGER ITSELF WHILE IT WAS BEING ADVANCED BY THE TECH. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12776833 ↗
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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