TECNIS IOL DFW150 (REF DFW150U095)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYNERGY TORII SMPCY 09.5D CYL1.50 · Class 3 · Implant
Data updated Oct 13, 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 05050474751057), received between Mar 8, 2022 and Jul 29, 2022 — classified as 1 injury, 1 malfunction.
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
- Adverse Event Without Identified Device or Use Problem1
- Break1
Patient problems
- Halo1
- No Clinical Signs, Symptoms or Conditions1
- 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 29, 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 FROM THE PATIENT'S LEFT EYE DUE TO HALO AND GLARE COMPLAINTS. IT WAS REPLACED WITH A DIFFERENT MODEL AND DIOPTER SIZE IOL. THE PATIENT WAS FINE POST-EXPLANT WITH NO FURTHER ACTION REQUIRED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Halo; Visual Disturbances
MAUDE report 15135660 ↗MalfunctionMar 8, 2022Break; Break
IT WAS REPORTED THAT THE PERIPHERY OF THE SYNERGY INTRAOCULAR LENS (IOL) HAS A CHIP IN IT AFTER IMPLANTATION IN THE PATIENT'S LEFT (OS) EYE. THE DOCTOR DID LEAVE THE LENS IN THE EYE AND WILL BE MONITORING THE PATIENT CLOSELY, BUT DOES NOT FORESEE ANY OPTICAL COMPLICATION DUE TO THE LOCATION OF THE CHIP. NO ADDITIONAL SURGICAL INTERVENTION WAS PERFORMED. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13700333 ↗
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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