TECNIS IOL DFW150 (REF DFW150U175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474751217), received between Apr 18, 2023 and Mar 15, 2024 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DFW150 17.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT 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 18.0 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 18913768 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) IS PLANNED TO BE REMOVED FROM THE PATIENT'S RIGHT EYE DUE TO VERY BOTHERSOME GLARE/HALOS. FURTHER FOLLOW-UP CONFIRMED THAT THE IOL WAS EXPLANTED AND REPLACED WITH DIU150, 17.0D. NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES DONE. NO PATIENT POST-EXPLANT INJURIES, PATIENT FINE POST-OP. PRODUCT ALREADY RETURNED TO US YESTERDAY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 16765999 ↗