TECNIS IOL DFW225 (REF DFW225U190)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYNERGY TORII SMPCY 19.0D 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474751835), received between Oct 20, 2021 and Nov 9, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
Patient problems
- Capsular Bag Tear2
- Visual Impairment2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Eye Injury1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 9, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE TECNIS SYNERGY SIMPLICITY INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DURING SECONDARY SURGERY DUE TO CAPSULAR RENT AND LENS MALPOSITION. VISUAL ACUITY WAS COUNTED IN FINGERS. REVERSE OPTIC CAPTURE WAS NOT STABLE FOR HIM. THERE WAS NO INFORMATION ABOUT INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY. THE LENS WAS REPLACED WITH ANOTHER COMPANY. THE PATIENT'S POST-PROCEDURE STATUS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear; Visual Impairment
MAUDE report 18104226 ↗InjuryOct 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE TECNIS SYNERGY PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE. THE REASON FOR THE EXPLANT IS UNKNOWN/NOT PROVIDED. NO ADDITIONAL SURGICAL INTERVENTION PERFORMED. THE PATIENT OUTCOME POST-SURGERY WAS NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Capsular Bag Tear; Eye Injury; Visual Impairment
MAUDE report 12669485 ↗
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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