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TECNIS IOL DFR00V (REF DFR00VU125)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS SYNERGY SIMPLICITY 12.5D · Class 3 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474750524), received between Apr 4, 2022 and May 5, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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

  • Break2
  • Adverse Event Without Identified Device or Use Problem1
  • Device Difficult to Setup or Prepare1
  • Mechanical Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • Blurred Vision1
  • Insufficient Information1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 5, 2023Break; Mechanical Problem; Device Difficult to Setup or Prepare; Break; Mechanical Problem; Device Difficult to Setup or Prepare

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) IS TOO STIFF TO IMPLANT. THE PLUNGER MISSED LENS. NO PATIENT CONTACT. THE PATIENT IS FINE POST-OP. THE PROCEDURE WAS COMPLETED WITH THE BACK-UP IOL. NO OTHER INFORMATION IS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16882268 ↗
  • MalfunctionApr 19, 2022Break; Break

    IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS DAMAGED INSIDE THE INJECTOR AND THE ISSUE WAS NOT NOTICED UNTIL AFTER THE LENS WAS IN THE PATIENT'S OPERATIVE EYE. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14150030 ↗
  • InjuryApr 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT WAS UNHAPPY WITH THE INTRAOCULAR LENS (IOL) IMPLANTED IN BOTH EYES. THE PATIENT HAD ¿TROUBLE¿ UPON WAKING UP FROM SURGERY AND WAS UNABLE TO ¿SEE MUCH ON ANYTHING AT FIRST WITH THE 1ST LENS EVERYTHING HAD AN EXTENSION TO THE BORDER AND VERY BLURRY.¿ THE PATIENT WAS UNABLE TO SEE FAR AWAY AND HAD TO WEAR GLASSES. THE PATIENT REPORTED THAT THE DOCTOR ADVISED THAT THE PATIENT'S BRAIN WAS NOT ADAPTING TO THE LENSES. AFTER A MONTH, THE PATIENT WAS ABLE TO SEE MID-RANGE AND CLOSE UP ENOUGH TO READ, BUT STILL DIFFICULTY WITH DISTANCE. THE PATIENT HAD AN IOL EXCHANGE IN BOTH EYES. ANOTHER JOHNSON & JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (LEFT EYE/OS: DIFFERENT MODEL, DIU150, DIFFERENT DIOPTER OF 14.5, CYLINDER 1.50; RIGHT EYE/OD: DIFFERENT MODEL, DIU150, SAME DIOPTER, CYLINDER 1.50). THE PATIENT REPORTED THAT THE LENS EXCHANGE SURGERY WAS "HORRIFIC," AS THE LENS HAD TO BE CUT IN HALF IN THE EYE IN ORDER TO BE REMOVED AND THE PATIENT CAN NOW SEE A BULGE/CUT ON EYE WHICH THE PATIENT'S THINKS IS SCAR TISSUE FROM THE INCISION ON THE "OUTER SIDE." NO FURTHER INFORMATION WAS PROVIDED. THROUGH FOLLOW-UP WITH THE DOCTOR, IT WAS LEARNED THAT THE PATIENT HAD 20/20 V

    Patient problems: Blurred Vision; Insufficient Information

    MAUDE report 14002797 ↗

Other Lens, multifocal intraocular devices

All Lens, multifocal intraocular devices →

Sources and updates

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