TECNIS IOL DFW150 (REF DFW150U205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474751279), received between Dec 8, 2021 and May 12, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Crack” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PRELOADED MULTIFOCAL TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO THE PATIENT'S COMPLAINT OF REFRACTIVE ERROR AND BLURRY DISTANCE VISION. IT WAS REPLACED DURING A SECONDARY SURGICAL PROCEDURE WITH A NON JNJ LENS. THERE WAS NO PATIENT INJURY. THE PATIENT IS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 22007301 ↗
• InjuryNov 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED. THE PATIENT HAD UNBALANCED VISUAL ACUITY AND HALOS. THE LENS WAS REPLACED WITH A DIFFERENT JNJ MODEL AND DIOPTER ( DXW150 21.5 DIOPTER). THE PATIENT DID NOT HAVE PRE-EXISTING ISSUES THAT CONTRIBUTED TO THE REPORTED EVENT. THERE WERE NO SURGICAL INTERVENTIONS SUCH AS A VITRECTOMY, INCISION ENLARGEMENT OR CAPSULE TEAR. REPORTEDLY, THE PATIENT OUTCOME IS PENDING. THE EXPLANTED IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo

  MAUDE report 18149214 ↗
• MalfunctionJun 29, 2022Crack; Crack

  IT WAS REPORTED THAT THE TIP OF THE PRELOADED DEVICE CARTRIDGE CRACKED ON THE ADVANCEMENT OF INTRAOCULAR LENS (IOL). ONLY THE CARTRIDGE TIP MADE CONTACT WITH PATIENT'S LEFT EYE. THERE WAS NO PATIENT INJURY AND THE PROCEDURE WAS COMPLETED USING ANOTHER LENS OF SAME MODEL AND DIOPTER. THE ORIGINAL DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14861229 ↗
• InjuryDec 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OCULAR DEXTER (RIGHT EYE). THE IOL WAS EXPLANTED IN A SEPARATE SURGICAL PROCEDURE DUE TO COMPLAINTS OF VISION NOT PERFECT AND HALOS, BUT THE PRIMARY REASON WAS DUE TO VISUAL ACUITY. IOL WAS REPLACED WITH ANOTHER JOHNSON & JOHNSON DIFFERENT MODEL LENS AND DIFFERENT DIOPTER SIZE, DFW225 22.0 DIOPTER. THERE WAS NO PATIENT INJURY, NO MEDICAL INTERVENTION, AND NO SURGICAL INTERVENTION. PATIENT OUTCOME POST-PROCEDURE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo

  MAUDE report 13007008 ↗
• InjuryDec 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE DUE TO PATIENT COMPLAINING OF WAXY VISION AND COULD NOT TOLERATE THE LACK OF CRISP, CLEAR VISION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 13006409 ↗
• InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO BLURRINESS IN DISTANCE VISION. THE PHYSICIAN STATED THERE WERE NO RESIDUAL ISSUES. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY. ANOTHER JOHNSON & JOHNSON ZXT150 LENS (DIFFERENT MODEL AND HIGHER DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Blurred Vision

  MAUDE report 12964218 ↗