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TECNIS IOL DFW300 (REF DFW300U170)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS SYNERGY TORII SMPCY 17.0D CYL3.00 · Class 3 · Implant

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 05050474752382), received between Dec 12, 2022 and Dec 12, 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. How this data works · Data updated Oct 13, 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.

  • InjuryDec 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE TECNIS MULTIFOCAL IOL WAS EXPLANTED DUE TO THE PATIENT EXPERIENCING HALOS AND GLARE. THEIR DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. THE PATIENT NEVER WANTED A MULTIFOCAL LENS AND PREFERS TO CONTINUE USING READING GLASSES. THE LENS WAS EXPLANTED AND REPLACED WITH A TECNIS MONOFOCAL LENS OF THE SAME DIOPTER. THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR, VITRECTOMY OR SUTURES. PRE-OPERATIVE VISION WAS 20/70. POST-OPERATIVE VISION IS 20/52 -2. REPORTEDLY, THE PATIENT APPEARED OK POST-OPERATIVELY. HOWEVER, THEY¿LL HAVE A BETTER IDEA WHEN THE PATIENT COMES IN FOR THEIR POST-OP VISIT. THE IOL WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: Halo; Visual Disturbances

    MAUDE report 15960764 ↗

Other Lens, multifocal intraocular devices

All Lens, multifocal intraocular devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.