TECNIS IOL DFW150 (REF DFW150U180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474751224), received between Dec 29, 2021 and Apr 1, 2024 — classified as 4 injuries, 1 malfunction.

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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2024Unstable; Unstable

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE DUE TO POSSIBLE ROTATION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH SAME MODEL LENS WITH1.75 D. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THERE WAS NO ISSUE WITH THE LENS. THERE WERE NO DEBILITATING CONDITION IN THE PATIENT. THERE WAS NO PATIENT INJURY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19015155 ↗
• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DFW150 18.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). PATIENT REPORTED COMPLAINTS OF ¿MUDDY¿ VISION AND SHE ALSO SEES HALOS WHEN DRIVING AT NIGHT. SHE ALSO MENTIONED ALSO THAT HER EYES ¿FLICKER¿ OR SHE SEES HALOS EVEN DAYLIGHT WHEN SHE LOOKS AT LIGHT. PATIENT IS NOT HAPPY THAT HER DOCTOR IS NOT WANTING TO REFUND HER MONEY AFTER LEARNING SHE NEEDS TO HAVE BOTH LENSES EXPLANTED; DUE FOR UPCOMING WEEK. PATIENT HAS OBTAINED A 2ND OPINION WHICH ALSO CONFIRMED THAT EXPLANTS WERE REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DIB00 18.5 DIOPTER IOL. PATIENT WAS UNHAPPY WITH HER VISION BUT NO INJURIES WERE REPORTED. IT WAS ALSO CONFIRMED THERE WAS NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE. PATIENT STATUS POST-LENS EXCHANGE WAS REPORTED AS EXCHANGED FOR DIB00 IOL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo

  MAUDE report 18913524 ↗
• InjuryJul 25, 2023Adverse 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 RIGHT EYE, DUE TO MECHANICAL COMPLICATIONS DESCRIBED AS HALOS/OVERCORRECTION. THIS WAS REPLACED WITH A MODEL DXR00V, 18.0 DIOPTER LENS. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES DONE. IT WAS NOTED THAT THE PATIENT IS CONTENT AND HAS SUCCESS WITH THE NEW LENS. NO OTHER PERTINENT INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Impairment

  MAUDE report 17392155 ↗
• InjuryMay 6, 2022Adverse 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 RIGHT EYE DUE TO BLURRY VISION. ACCOUNT INDICATED THAT PATIENT COULD NOT SEE STREET SIGNS OR TELEVISION CLEARLY AT 1 WEEK POST IOL IMPLANTATION AND VISION FLUCTUATED AS WELL AS THE MANIFEST REFRACTION. ONCE REFRACTION WAS STABILIZED PATIENT DECIDED ON YTTRIUM ALUMINUM GARNET (YAG) CAPSULOTOMY HOPING IT WOULD HELP. BUT IN THE END PATIENT STILL UNSATISFIED, HENCE DOCTOR EXPLANTED THE IOL. PRE-OPERATIVE VISUAL ACUITY 20/60, POST-OPERATIVE 20/30 -2. IT WAS PROVIDED THAT THE INCISION WAS ENLARGED DURING THE EXPLANT. EXPLANTED LENS WAS REPLACED WITH A DIFFERENT MODEL AND DIOPTER IOL (MODEL ZCU225, 17.0 D). THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 14308094 ↗
• InjuryDec 29, 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 PATIENT NOT LIKING HALOS AND GLARE-PHOTOPSIA. VISUAL ISSUES OCCURRED 1 DAY POST IMPLANT. THERE WAS AN INCISION ENLARGEMENT. THE IOL WAS REPLACED WITH A DIFFERENT LENS MODEL AND DIOPTER (19.0D). PATIENT IS HAPPY WITH 20/20 VISUAL ACUITY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 13114537 ↗