TECNIS IOL DFW300 (REF DFW300U205)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS SYNERGY TORII SMPCY 20.5D CYL3.00 · 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 05050474752450), received between Dec 15, 2021 and Jul 1, 2022 — classified as 2 injuries.
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 Problem2
Patient problems
- Halo2
- Flashers1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE DFW300U205 WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). ONE (01) MONTH POST-OPERATIVELY PATIENT REPORTED COMPLAINTS OF FLICKERS OF LIGHT, HALOS, AND DIFFICULTY DRIVING AT NIGHT. THE IOL WAS EXPLANTED AND REPLACED WITH ANOTHER JOHNSON & JOHNSON LENS, MODEL ZCU225 22.5 DIOPTER LENS. PATIENT STATUS WAS REPORTED AS TEMPORARILY IMPAIRED. THERE WAS NO COMPLICATION, SUCH AS CAPSULE TEAR, NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY PERFORMED. PATIENT WAS REPORTED NO LONGER TEMPORARILY IMPAIRED POST-LENS EXCHANGE. THE IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE
Patient problems: Flashers; Halo
MAUDE report 14890352 ↗InjuryDec 15, 2021Adverse 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 RIGHT EYE DUE TO PATIENT BEING UNHAPPY WITH SEEING HALOS FOLLOWING IOL IMPLANTATION SURGERY. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE DURING EXPLANT. THE EXPLANTED IOL WAS REPLACED WITH A ZXT300 MODEL LENS OF THE SAME DIOPTER POWER. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Halo
MAUDE report 13014753 ↗
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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