TECNIS IOL DXW150 (REF DXW150U250)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474763074), received between Nov 17, 2023 and Mar 7, 2024 — classified as 2 injuries.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DXW150 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). DUE TO COMPLAINTS OF DISTANCE VISION NOT BEING CRISP, 10 PT NEAR VISION (NV), NIGHTTIME HALOS, AND SAFE NIGHTTIME DRIVING, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE. THE EXPLANTED IOL WAS REPLACED WITH A ZCT150 24.5 IOL. THERE WAS NO INCISION ENLARGEMENT, NO SUTURE(S), NO VITRECTOMY, NO MEDICAL ATTENTION, AND NO MEDICATION PRESCRIBED (OUTSIDE OF STANDARD CARE). DEVICE DIRECTIONS FOR USE WERE FOLLOWED. PATIENT OUTCOME POST-LENS EXCHANGE WAS REPORTED AS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 18856756 ↗
• InjuryNov 17, 2023Unstable; Unstable

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT¿S RIGHT EYE DUE TO A TEN (10) DEGREES LENS ROTATION POST IMPLANTATION. THE DOCTOR WANTED TO DO A LENS ROTATION AND NOTICED FIBROSIS WHICH REPORTEDLY WAS DUE TO THE LENS BEING IN THE EYE FOR AN EXTEND DURATION OF TIME. THE DOCTOR WAS UNABLE TO ROTATE THE LENS AND THE LENS WAS EXPLANTED. A REPLACEMENT LENS OF THE SAME MODEL AND DIOPTER WAS IMPLANTED. NO OTHER SURGICAL INTERVENTIONS REQUIRED, AND NO PATIENT INJURY REPORTED. THE PATIENT IS HAPPY AND EXCITED WITH THE REPLACEMENT LENS WITH 20/20 VISUAL ACUITY AT 1-MONTH POST-OP. THE LENS NEEDED TO BE CUT UP AND REMOVED AND WILL NOT BE RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Contracture

  MAUDE report 18166141 ↗