Skip to content

TECNIS IOL DFW300 (REF DFW300U115)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS SYNERGY TORII SMPCY 11.5D 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 05050474752276), received between Dec 15, 2022 and Dec 15, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical Problem” (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
  • Mechanical Problem1

Patient problems

  • Blurred Vision1
  • Eye Injury1
  • Halo1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 15, 2022Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical 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 A MECHANICAL FAILURE. THE INCISION WAS ENLARGED TO REMOVE THE LENS IN WHOLE, HOWEVER, SUTURES AND A VITRECTOMY WERE NOT REQUIRED. THERE WAS NO PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: Blurred Vision; Eye Injury; Halo

    MAUDE report 15993159 ↗

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.