TECNIS IOL DFW150 (REF DFW150U225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05050474751316), received between Jul 14, 2021 and Jan 16, 2025 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJan 16, 2025Scratched Material; Scratched Material

  A SCRATCHED/DEFECTIVE DFW150 MODEL INTRAOCULAR LENS (IOL) WAS NOTED FOLLOWING IT'S IMPLANTATION IN THE PATIENT'S OPERATIVE EYE. THE DFW150 IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH ANOTHER DXR00V 22.5 DIOPTER IOL. THERE WAS NO INCISION ENLARGEMENT, NO PROCEDURAL DELAYS, NO SUTURES, AND NO VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE. NO MEDICAL ATTENTION WAS REQUIRED AND NO MEDICATION WAS PRESCRIBED (OUTSIDE OF STANDARD CARE). THERE WERE NO DAILY ACTIVITIES THAT THE PATIENT COULD NOT PERFORM THAT THEY WERE ABLE TO PRIOR TO THE SURGERY. PATIENT STATUS WAS REPORTED AS FULLY RECOVERED. THE IOL DIRECTIONS FOR USE WERE FOLLOWED. PATIENT INFORMATION CANNOT BE PROVIDED DUE TO DATA PRIVACY LEGISLATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21165288 ↗
• MalfunctionOct 23, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  THE PRE-LOADED DFW150 MODEL INTRAOCULAR LENS (IOL) WAS REPORTED TO NOT UNFOLD WHEN INSERTING. EXTENT OF PATIENT CONTACT IS UNKNOWN. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20519462 ↗
• InjurySep 5, 2024Adverse 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 FROM THE PATIENT'S LEFT EYE. THE IOL WAS EXPLANTED BY ANOTHER PRACTICE. THE REASON FOR THE EXPLANT IS THE PATIENT REPORTED SEVERE HALOS AND GLARE AND WAS UNHAPPY. THE SYMPTOMS WERE DEBILITATING AS THE PATIENT COULD NOT DRIVE AT NIGHT. THE IOL WAS REPLACED WITH A MONOFOCAL LENS. SUTURES WERE NOT REQUIRED. THE PATIENT'S PRE-OPERATIVE VISION WAS 20/30. POST-OPERATIVE VISION 20/30+. THE PATIENT IS DOING WELL AND HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 20147671 ↗
• InjuryJul 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT THE PATIENT HAD RESIDUAL REFRACTIVE ERROR WITH DFW150U225 LENS AND DOCTOR WAS PLANNING TO REPLACE WITH ANOTHER SYNERGY LENS. ADDITIONAL INFORMATION RECEIVED REVEALED THAT THE SURGEON CUT THE LENS INTO 3 PIECES TO REMOVE AND NO WIDENING OF THE INCISION OR SUTURES WERE USED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 17251107 ↗
• MalfunctionJun 19, 2023Break; Break

  IT WAS REPORTED THAT THE DOCTOR OBSERVED A DEFECT ON AN INTRAOCULAR LENS (IOL). LOOKING THROUGH THE SLIT LAMP IT APPEARED THAT THE CENTER RING WAS SMEARED ON THE LENS. THE LENS REMAINS IMPLANTED IN THE PATIENT¿S LEFT EYE, AND THE DOCTOR IS NOT EXPLANTING THE LENS AT THIS TIME. ADDITIONAL INFORMATION INDICATED CONFIRMED THAT THE LENS REMAINS IMPLANTED. THAT THERE HAVE BEEN NO INTERVENTIONS AND NO INJURY REPORTED. THE PATIENT HAS NO COMPLAINTS OR ISSUES. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENS IMPLANTATION. THIS REPORT IS FOR PATIENT¿S LEFT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT EYE OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17159616 ↗
• MalfunctionJun 19, 2023Break; Break

  IT WAS REPORTED THAT THE DOCTOR OBSERVED A DEFECT ON AN INTRAOCULAR LENS (IOL). LOOKING THROUGH THE SLIT LAMP IT APPEARED THAT THE CENTER RING WAS SMEARED ON THE LENS. THE LENS REMAINS IMPLANTED IN THE PATIENT¿S RIGHT EYE, AND THE DOCTOR IS NOT EXPLANTING THE LENS AT THIS TIME. ADDITIONAL INFORMATION INDICATED CONFIRMED THAT THE LENS REMAINS IMPLANTED. THAT THERE HAVE BEEN NO INTERVENTIONS AND NO INJURY REPORTED. THE PATIENT HAS NO COMPLAINTS OR ISSUES. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENS IMPLANTATION. THIS REPORT IS FOR PATIENT¿S RIGHT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17159603 ↗
• InjuryJun 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED GLARE, BLURRY VISION, AND LIGHT SENSITIVITY WITH LOSS OF 2 OR MORE LINES OF BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA) POST INTRAOCULAR LENS (IOL) IMPLANTATION IN THEIR LEFT EYE. IOL REMOVAL IS PLANNED AS SYMPTOMS SIGNIFICANTLY INTERFERE WITH THEIR DAILY ACTIVITIES (NO SCHEDULED DATE YET). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 14795175 ↗
• InjuryJun 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO THE PATIENT BEING UNHAPPY AND SEEING HALOS. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. ANOTHER JOHNSON & JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIFFERENT MODEL, DIU150, DIFFERENT DIOPTER OF 24.5). THE PATIENT IS WELL POST-OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo

  MAUDE report 14609730 ↗
• MalfunctionOct 4, 2021Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT WHILE INSERTING A DFW150 MODEL INTRAOCULAR LENS (IOL) INTO PATIENT'S LEFT EYE, THE LENS CAME OUT OF THE CARTRIDGE BEFORE IT WAS COMPLETELY IN THE EYE WHICH CAUSED THE LENS TO BE HALFWAY OUT OF THE CARTRIDGE AND COULD NOT RELOAD IT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS OF SAME MODEL AND DIOPTER. THERE WAS NO PATIENT INJURY AND NO MEDICAL/ SURGICAL INTERVENTIONS WERE DONE. PATIENT WAS DOING GOOD AT THE TIME OF DISCHARGE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12573845 ↗
• MalfunctionJul 14, 2021Break; Operating System Becomes Nonfunctional; Break; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT THE TECHNICIAN ROTATED PRE-LOAD INJECTOR MULTIPLE TIMES, THEN LET THE INJECTOR SIT FOR APPROXIMATELY 5 MINUTES PRIOR TO IMPLANTATION WHEN IT WAS NOTED THE INTRAOCULAR LENS (IOL) HAD A LENS CRACK AFTER INSERTING THE IOL INTO THE RIGHT EYE. THE SURGEON SUSPECTS THE PLUNGER CRACKED THE IOL. THE LENS WAS REMOVED DURING THE SAME PROCEDURE AND WAS DISCARDED. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO PATIENT INJURY. THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12169584 ↗