TECNIS IOL DXW150 (REF DXW150U155)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474762886), received between Aug 11, 2022 and Oct 18, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (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.

• InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE. DOCTOR EXPLAINED THAT THE PATIENT HAS A SYNERGY TORIC LENS AND POOR QUALITY VISION BUT THE PROBLEM IS REALLY THAT THEY HAVE ADVANCES VISUAL FIELD LOSS IN BOTH EYES AND A MACULAR CYST IN ONE EYE. THE DOCTOR¿S POINT OF VIEW IS THE PATIENT IS NOT A GOOD CANDIDATE FOR A PRESBYOPIA CORRECTING LENS AND EXPLAINED TO THE PATIENT AND FAMILY THAT THE VISION WOULD BE IMPROVED BUT NOT NORMALIZED BY AN IOL EXCHANGE FOR A MONOFOCAL TORIC. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision

  MAUDE report 17959689 ↗
• MalfunctionAug 11, 2022Difficult to Fold, Unfold or Collapse; Inaccurate Delivery; Difficult to Fold, Unfold or Collapse; Inaccurate Delivery

  IT WAS REPORTED THAT THE TRAILING HAPTIC OF THE INTRALOCULAR LENS (IOL) DID NOT FOLD ON TOP OF THE LENS AND AS A RESULT THE HAPTIC GOT STUCK BETWEEN THE PLUNGER AND THE CARTRIDGE. THE SURGEON HAD TO PULL THE TIP PARTIALLY OUT OF THE INCISION TO GRAB THE HAPTIC AND CAREFULLY TEASE IT FROM CARTRIDGE. THE IOL REMAINS IMPLANTED IN THE PATIENT'S LEFT EYE. NO DAMAGE WAS REPORTED TO THE CARTRIDGE OR TIP AND IT WAS CONFIRMED THAT THE LENS WAS NOT POSITIONED CLOSER TO THE TIP OF THE CARTRIDGE THAN NORMAL. THERE WERE NO DELAY IN SURGERY AND NO SURGICAL AND/OR MEDICAL INTERVENTIONS REQUIRED. THE INJECTOR WAS THROWN AWAY AFTER THE CASE WAS OVER. THERE WAS NO REPORTED PATIENT INJURY AND PATIENT OUTCOME WAS REPORTED TO BE FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15214383 ↗