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TECNIS IOL DFW300 (REF DFW300U125)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS SYNERGY TORII SMPCY 12.5D 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 05050474752290), received between Sep 27, 2023 and Sep 27, 2023 — classified as 1 injury.

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

  • Unstable1

Patient problems

  • Blurred Vision1
  • Visual Impairment1

Recent adverse event reports

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

  • InjurySep 27, 2023Unstable; Unstable

    IT WAS REPORTED THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S LEFT EYE. THEIR LEFT EYE HAD A CATARACT THAT WAS BEGINNING TO BE NOTICEABLE AND HAD AN UNCORRECTED VISUAL ACUITY (UVA) OF 20/500. THEIR RIGHT EYE UVA IS 20/400 BUT THEY ELECTED NOT TO TREAT IT. HE¿S A LONG TIME CONTACT WEARER AND CONTINUES TO WEAR A CONTACT IN THEIR RIGHT EYE. THE PATIENT FEELS HIS BACKGROUND IS APPLICABLE TO THIS REPORT AND EXPLAINED THAT HE IS FAMILIAR WITH OPTICS AS HE IS A RETIRED COMPUTER ENGINEER AND MANAGER WHO IS FAMILIAR WITH OPTICS OUTSIDE THE EYE. HE SPECIFICALLY SEARCHED FOR A SURGEON WHO IS EXPERIENCED WITH THE TECNIS SYNERGY TORIC II IOL. IN PREPARATION FOR THE IMPLANT IN THEIR LEFT EYE, THE PATIENT PREVIEWED SEVERAL IOLS, AND DETERMINED THE JNJ TECNIS SYNERGY TORIC II LENS IS SUPERIOR BECAUSE IT WOULD GIVE HIM THE ¿WIDEST RANGE OF VISION FREE OF GLASSES¿. THE PATIENT PLANNED TO HAVE INTERMEDIATE AND DISTANCE VISION AS CLOSE AS POSSIBLE TO 20/20, AND IF NEEDED WEAR READERS FOR NEAR VISION. ADDITIONALLY, THE PATIENT REVIEWED THE IOL SPECIFICATION SHEET WITH A TECHNICIAN BUT BECAME CONCERNED WHEN THE TECHNICIAN SAID THAT DOCTORS AND TECHNICIANS USUALLY KN

    Patient problems: Blurred Vision; Visual Impairment

    MAUDE report 17826075 ↗

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.