TECNIS IOL DXW150 (REF DXW150U215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474763005), received between Oct 6, 2023 and Jul 31, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2026Device Dislodged or Dislocated

  It was initially reported that following implantation of a preloaded multifocal intraocular lens (IOL), model DXW150, the patient experienced halos, and a postoperative flipped axis was observed. Due to these symptoms, the implanted lens was explanted during a secondary surgical procedure and replaced with a ZCB00 21.5 D IOL (SN (b)(6)).Additional follow-up information indicated that the patient was a glaucoma suspect in both eyes (OU) and had previously undergone cataract surgery with implantation of a toric extended depth of focus (EDOF) IOL and a Kahook Dual Blade (KDB) procedure in the left eye (OS). The postoperative course was complicated by significant visual distortions and UGH (Uveitis-Glaucoma-Hyphema) syndrome in the left eye, which necessitated an IOL exchange procedure.Intraoperative findings during the lens exchange revealed that the toric IOL was positioned at the 108-degree meridian, with the trailing haptic located in the sulcus. Fibrosis of the inferior capsule was also noted. The patient's ocular history was significant for dry eye syndrome and myopia. The patient's medical history included insomnia, depression, and attention-deficit/hyperactivity disorder (ADHD)

  Patient problems: Capsular Contracture; Halo; Uveitis; Visual Disturbances; Visual Impairment

  MAUDE report 50100788 ↗
• InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S LEFT EYE. THE PATIENT WAS NOT ABLE TO HANDLE THE MULTIFOCALITY OF THE IOL. THE PATIENT WAS UNABLE TO SEE CLEARLY, NOT HAPPY WITH THEIR VISION. THE PATIENT STATED, ¿SOMETHING IS WRONG WITH MY VISION¿. THE EXPLANTED IOL WAS REPLACED WITH A BAUSCH AND LOMB LENS, MODEL 21.5 LI61A0. THE PATIENT WAS NOT INJURED AND THERE WAS NO MEDICAL INTERVENTION OR COMPLICATIONS SUCH AS A CAPSULE TEAR, VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES. THE PATIENT WAS REPORTED AS DOING WELL SO FAR. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 21713497 ↗
• InjuryOct 6, 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 LEFT EYE, DUE TO PATIENT NOT PLEASED WITH THE OUTCOME. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES PERFORMED. REPLACEMENT IOL WAS A ZCU150, 21.5D POWER SIZE. THE PATIENT OUTCOME REPORTED AS GOOD POST OPERATIVE APPEARANCE, STABLE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort

  MAUDE report 17892454 ↗