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TECNIS IOL DFW375 (REF DFW375U140)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS SYNERGY TORII SMPCY 14.0D CYL3.75 · 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 05050474752917), received between Aug 15, 2022 and Aug 15, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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

  • Break1

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.

  • MalfunctionAug 15, 2022Break; Break

    IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAD A DEFECT ON IT. THERE WAS NO CONTACT WITH PATIENT'S RIGHT EYE. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15228641 ↗

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.