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TECNIS IOL DFW150 (REF DFW150U125)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS SYNERGY TORII SMPCY 12.5D CYL1.50 · Class 3 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474751118), received between Feb 18, 2022 and Jun 8, 2023 — classified as 1 injury, 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

  • Adverse Event Without Identified Device or Use Problem1
  • Break1

Patient problems

  • Halo1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE, THE PATIENT IS UNHAPPY WITH THE IOL. THE LENS WAS IMPLANTED TO IMPROVE NEAR VISION, HOWEVER THE PATIENT FEELS THAT THE ADDITIONAL HALOS ARE "INTOLERABLE". AN IOL EXCHANGE HAS BEEN SCHEDULED TO PLACE ANOTHER JOHNSON AND JOHNSON IOL AS REPLACEMENT (DIFFERENT MODEL, DXW150). ADDITIONAL INFORMATION WAS RECEIVED ON MAY 18, 2023 REPORTING THAT THE IOL WAS EXCHANGED ON (B)(6) 2023. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIFFERENT MODEL, DXW150, DIFFERENT DIOPTER, 13.0). NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURE WAS REQUIRED. THE CAPSULE IS INTACT. THE PATIENT IS POST-OPERATIVE DAY ONE, SO IT IS TOO EARLY TO TELL PATIENT STATUS. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: Halo

    MAUDE report 17094415 ↗
  • MalfunctionFeb 18, 2022Break; Break

    IT WAS REPORTED THAT DURING IMPLANTATION THE PRE-LOADED INTRAOCULAR LENS (IOL) HAPTIC BROKE. ACCOUNT INDICATED THAT THE CARTRIDGE TIP HAD PATIENT CONTACT AND THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13562135 ↗

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.