TECNIS IOL DFW225 (REF DFW225U220)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYNERGY TORII SMPCY 22.0D CYL2.25 · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474751897), received between Dec 2, 2021 and Feb 24, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Scratched Material” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Scratched Material1
Patient problems
- Blurred Vision1
- No Clinical Signs, Symptoms or Conditions1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PERSISTENT BLURRED VISION, SPLITTING IMAGES VERTICALLY AND POOR ACUITY AT ALL DISTANCE DURING POST OPERATION VISIT AFTER A PRELOADED INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO HIS LEFT EYE. THE PRE-OP VISUAL ACUITY WAS 20/80. DURING THE POST-OP VISIT ON (B)(6) 2021, THE VISUAL ACUITY WAS 20/80 INTERMEDIATE, HOWEVER, THIS WAS FOUND IMPROVED TO 20/20 INTERMEDIATE ON FURTHER VISITS ON (B)(6) 2021. THE ISSUE DID NOT AFFECT PATIENT'S ABILITY PERFORM DAILY ACTIVITIES. ADDITIONAL INFORMATION RECEIVED REVEALED THAT THE ORIGINAL LENS WAS EXPLANTED AND A REPLACEMENT LENS OF DIFFERENT MODEL, ZCT225 BUT OF LOWER DIOPTER (21.5D) WAS PLACED. THE PATIENT WAS DOING GOOD POST EXPLANT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 13589774 ↗MalfunctionDec 2, 2021Scratched Material; Scratched Material
IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) CAME OUT WITH SCRATCH ON IT'S ANTERIOR SIDE. THE LENS WAS REMOVED FROM THE PATIENT'S OPERATIVE EYE RIGHT AWAY AND A NEW LENS OF SAME MODEL WAS PLACED AS THE REPLACEMENT. THERE WAS NO FURTHER COMPLICATIONS AND THE PATIENT WAS DOING GREAT POST-OPERATION. NO SURGICAL AND/OR MEDICAL INTERVENTIONS WERE INDICATED AND NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12914961 ↗
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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