TECNIS IOL DFR00V (REF DFR00VU170)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYNERGY SIMPLICITY 17.0D · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474750616), received between Feb 11, 2022 and Feb 11, 2022 — classified as 1 injury.
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
Patient problems
- Halo1
- Visual Disturbances1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT ENDED UP OU (BOTH EYES) 20/20 J1, BUT COULD NOT TOLERATE THE GLARE AND HALO AFTER THE IMPLANTATION WITH THE SYNERGY INTRAOCULAR LENSES (IOLS). AFTER THE POST-OPERATIVE (OP) 1 MONTH APPOINTMENT, THE LENSES WERE EXPLANTED AND REPLACED WITH NON-JOHNSON AND JOHNSON LENSES. THE REPLACEMENT LENSES ARE THE B & L MX60E MONOFOCAL LENSES. THE SUSPECT IOLS WERE DISCARDED AND ARE NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT REPRESENTS THE RIGHT (OD) EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT (OS) EYE.
Patient problems: Halo; Visual Disturbances
MAUDE report 13511671 ↗
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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