TECNIS IOL DXW150 (REF DXW150U200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474762978), received between May 2, 2023 and Mar 31, 2026 — classified as 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED BLURRY DISTANCE AND NEAR VISION FOLLOWING THE FULL IMPLANTATION OF A SINGLE-PIECE PRELOADED TORIC EDOF INTRAOCULAR LENS (IOL) IN THE PATIENT¿S RIGHT EYE. THE ORIGINAL LENS WAS SUBSEQUENTLY EXPLANTED DURING A SECONDARY SURGERY ON THE SAME DAY. PREOPERATIVE BEST-CORRECTED VISUAL ACUITY (BSCVA) WAS 20/20, AND POSTOPERATIVE BSCVA REMAINED 20/20. DAILY ACTIVITIES WERE NOT AFFECTED. NO UNPLANNED SURGICAL INTERVENTIONS, SUCH AS INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY, WERE REQUIRED. NO MEDICATIONS OUTSIDE THE STANDARD OF CARE WERE PRESCRIBED, AND NO SURGICAL DELAYS WERE REPORTED. THE DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT EXPERIENCED TEMPORARY BILATERAL VISUAL IMPAIRMENT. ADDITIONAL INFORMATION WAS RECEIVED ON THE PATIENT'S RIGHT EYE. THE DEVICE WAS REPORTED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE PATIENT WAS NOTED TO BE UNDER-CORRECTED WITH NO LOSS OF TWO OR MORE LINES OF BEST SPECTACLE CORRECTED VISUAL ACUITY AND NO OVERCORRECTION. THE PRE-OPERATIVE REFRACTION WAS +0.25 -1.00 X 130 WITH A POST-OPERATIVE REFRACTION OF +0.75 SPHERE AND AN INTENDED TARGET REFRACTION OF PLANO. A PRE-EXISTING CONDITION AFFECTING CALCULATION W

  Patient problems: Blurred Vision

  MAUDE report 24742009 ↗
• MalfunctionMar 14, 2025Contamination; Contamination

  IT WAS REPORTED THAT PRELOADED TORIC LENS WAS IMPLANTED AND THEN EXPLANTED DURING THE SAME PROCEDURE. IT WAS NOTED THAT THERE APPEARED TO BE AN EXTERNAL FOREIGN THREAD ADHERED TO THE LENS. THE PATIENT WAS NOT HARMED DURING THE PROCEDURE. NO FURTHER INFOMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21612778 ↗
• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DOCTOR REPORTED A PLANNED EXPLANT OF A SYMFONY TORIC INTRAOCULAR LENS (IOL) AS THE PATIENT WAS VERY UNHAPPY WITH DYSPHOTOPSIA AND WANTED THE LENS REMOVED. IT WAS CONFIRMED THAT THE PATIENT DID NOT HAVE ANY PRE-EXISTING ISSUE WHICH CONTRIBUTED TO THE REPORTED EVENT. THROUGH FOLLOW UPS, IT WAS LEARNED THAT THE LENS WAS EXPLANTED FROM THE PATIENT'S LEFT EYE AS SCHEDULED ON (B)(6) 2024. A NON JOHNSON & JOHNSON LIGHT ADJUSTABLE LENS (LAL) OF 19.0 DIOPTER WAS USED AS A REPLACEMENT. THERE WERE NO OTHER SURGICAL INTERVENTIONS REQUIRED. THE PATIENT OUTCOME WAS GOOD AND NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 19316125 ↗
• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IOL WAS EXPLANTED FROM THE RIGHT EYE DUE TO HALOS AND GLARES WHICH PATIENT DID NOT LIKE IT. THE EXPLANTED LENS WAS REPLACED WITH ANOTHER JNJ LENS WITH THE SAME MODEL AND DIOPTER. THERE WERE NO PATIENT INJURIES OR NO OTHER MEDICAL OR SURGICAL INTERVENTION REQUIRED. PATIENT WAS DOING WELL. UPON FURTHER FOLLOW UP, IT WAS INFORMED THAT THE LENS WAS THROWN AWAY, SO THERE IS NO LENS BEING RETURNED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort; Halo; Visual Disturbances

  MAUDE report 16855210 ↗