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TECNIS IOL DFR00V (REF DFR00VU105)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS SYNERGY SIMPLICITY 10.5D · Class 3 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474750487), received between Jan 5, 2022 and Jan 5, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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

  • Material Split, Cut or Torn1
  • Operating System Becomes Nonfunctional1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionJan 5, 2022Operating System Becomes Nonfunctional; Material Split, Cut or Torn; Operating System Becomes Nonfunctional; Material Split, Cut or Torn

    IT WAS REPORTED AFTER IMPLANTATION INTO THE PATIENT'S OPERATIVE EYE THE PRE-LOADED INTRAOCULAR LENS (IOL) HAD A CUT IN THE OPTIC; THE CUT IS NOT ALL THE WAY THROUGH THE LENS. THE SALES REPRESENTATIVE THINKS THE PLUNGER IS CUTTING THE LENS. NO SURGICAL INTERVENTION IS SCHEDULED AT THIS TIME. THE DOCTOR IS GOING TO OBSERVE PATIENT OUTCOME. THE IOL IS NOT BEING RETURNED AS IT REMAINS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13170465 ↗

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.