TECNIS IOL DFW150 (REF DFW150U240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474751347), received between Dec 14, 2021 and Dec 11, 2024 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Contamination” (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.

• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BILATERAL CATARACT SURGERY 60 DAYS AGO. THE SURGERY WENT WELL WITHOUT COMPLICATIONS. THE PATIENT PRESENTED BILATERAL VISUAL ACUITY OF 20/20, NOT WEARING GLASSES. 60 DAYS POST-OPERATION, THE PATIENT RETURNED COMPLAINING OF SEVERE PHOTOPHOBIA. THE PHYSICIAN FOUND NO ISSUES WITH THE SURGERY AND NO CLINICAL FINDINGS TO EXPLAIN THE SYMPTOMS. THE PHYSICIAN BELIEVES THE PATIENT MAY HAVE A RHEUMATOLOGIC INFLAMMATORY PROCESS AND HAS PRESCRIBED CORTICOSTEROID EYE DROPS. THE PHYSICIAN IS MONITORING THE PATIENT. THROUGH FOLLOW-UP, WE LEARNED THAT THE PATIENT HAS A MEDICAL HISTORY OF RHEUMATISM AND DID NOT PRESENT ANY OTHER SYMPTOMS. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WERE PERFORMED TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED. NOTE: A SEPARATE REPORT WILL BE SUBMITTED FOR EACH LENS. THIS IS REPORT 1 OF 2.

  Patient problems: Visual Disturbances

  MAUDE report 20908582 ↗
• InjuryDec 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRE-LOADED DFW150 MODEL INTRAOCULAR LENS (IOL) WAS REPORTED TO HAVE WAS IMPLANTED IN THE PATIENT¿S OPERATIVE EYE. IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED DUE TO UNKNOWN REASONS AND THE EXPLANTED IOL WAS REPLACED WITH A DRT225 23.0 DIOPTER IOL. THE PATIENT IS A POST-LASIK PATIENT. PATIENT STATUS POST LENS EXCHANGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 20873483 ↗
• InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD CATARACT PROCEDURE AND LENS WAS IMPLANTED IN LEFT EYE ON (B)(6) 2022 AND FEMTO WAS USED. ON ONE DAY POST OPERATIVE EXAMINATION, PATIENT WAS TAKING PREDNISOLONE/MOXIFLOXACIN FOUR TIMES A DAY IN LEFT EYE. PATIENT STATED EYE WAS IRRITATED ON THE NIGHT OF SURGERY THAT IT WAS BLURRY AND SHE KEPT IT CLOSED. PATIENT WAS ASKED TO CONTINUE USING PREDNISOLONE/GATIFLOXACIN FOUR TIMES A DAY. PATIENT WAS ASKED TO BEGIN USING PREDFORTE ARTIFICIAL TEARS IN BOTH EYES AS NEEDED. PATIENT WAS ASKED TO BEGIN USING COMBIGAN TWICE A DAY TO ADDRESS THE ELEVATED INTRAOCULAR PRESSURE. ON SECOND POST OPERATIVE EXAMINATION ON (B)(6) 2022, PATIENT STATED THAT SHE WAS FEELING LIKE A LIGHT IS FLASHING ON LEFT EYE. PATIENT STILL USING PREDNISOLONE/GATIFLOXACIN DROPS FOR TIMES A DAY. PATIENT WAS ASKED TO TAPER PREDNISOLONE/GATIFLOXACIN TO TWICE A DAY IN LEFT EYE. COULD CONSIDER REMOVING SUTURE AT NEXT VISIT. ON THIRD POST OPERATIVE EXAMINATION ON (B)(6) 2022, PATIENT STATED THAT SHE WAS STILL SEEING BLURRY AND STILL SEEING FLASHES OF LIGHT. FLASHES LOOK LIKE LIGHTNING AND SOME LIGHTS HAVE HALOS AROUND THEM AND STILL COULD NOT SEE SMALL PRINT AND WEARING SHADES BECAUSE OF LIGHT SEN

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Eye Pain; Flashers; Foreign Body Sensation in Eye; Halo; Intraocular Pressure Increased; Red Eye(s); Visual Disturbances; Visual Impairment

  MAUDE report 16456654 ↗
• InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS DISSATISFIED WITH THE VISUAL OUTCOME OF THE IMPLANTED INTRAOCULAR LENS (IOL). THROUGH FOLLOW-UP IT WAS LEARNED THAT THE IOL WAS EXPLANTED FROM THE RIGHT EYE DUE TO POOR DISTANCE VISION DESPITE PLANO OUTCOME. THE PATIENT WAS UNABLE TO DRIVE AND WORK ON THE COMPUTER DUE TO THE VISUAL ISSUE. ANOTHER JOHNSON & JOHNSON IOL WAS IMPLANTED AS THE REPLACEMENT LENS (DIFFERENT MODEL, DXW150, DIFFERENT DIOPTER OF +24.5). THE INCISION WAS ENLARGED. THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT IS CURRENTLY DOING BETTER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 14739322 ↗
• MalfunctionMar 30, 2022Contamination; Contamination

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) CAME OUT OF THE CARTRIDGE WITH SMALL PIECES OF WHAT LOOKS LIKE PLASTIC STUCK TO THE LENS. FIRST COUPLE HAD SEEMED SMALL BUT THE ONE THEY TOOK PICTURE OF, THE DOCTOR ACTUALLY HAD TO USE FORCEPS TO REMOVE. NO FURTHER INFORMATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13955233 ↗
• 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 THE PATIENT PERSISTENTLY COMPLAINED OF DYSPHOTOPSIA. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Visual Disturbances

  MAUDE report 13004755 ↗