TECNIS IOL DXW150 (REF DXW150U210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474762992), received between Jun 5, 2023 and May 12, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE AS THE PATIENT COMPLAINED OF BLURRY VISION AND THEY CLAIM THE LENS CONTRIBUTED TO THE VISUAL ISSUE. THERE WAS -0.9 D MYOPIC MISS. THE ISSUE WAS FIRST NOTICED DURING POST-OP EXAMINATION. THERE WERE NO DEBILITATING CONDITIONS AND THE SYMPTOMS DID NOT SIGNIFICANTLY INTERFERE WITH DAILY ACTIVITIES. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH A SAME MODEL LENS WITH 20.0 DIOPTER. THE PATIENT FEELS BETTER WITH THE REPLACED LENS. THE BEST CORRECTED VISUAL ACUITY PRE-OP WAS 20/25 AND THE BEST CORRECTED VISUAL ACUITY POST-OP WAS 20/25. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 22007102 ↗
• MalfunctionJan 11, 2024Break; Component Missing; Ejection Problem; Break; Component Missing; Ejection Problem

  IT WAS REPORTED THAT THE PRELOADED TORIC INTRAOCULAR LENS (IOL) WAS OPENED DURING SURGERY AND WAS FOUND TO BE DEFECTIVE, AS THE INJECTOR WENT ABOVE THE LENS INSTEAD OF PROGRESSING THE LENS. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE CARTRIDGE TIP WAS INSERTED INTO THE EYE WOUND AND THE LENS WOULD NOT ADVANCE. WHEN THE SURGEON SAW THIS, IT WAS ALSO NOTICED THAT THE LENS WAS CRACKED IN SEVERAL PLACES, SO THE SURGEON WITHDREW THE CARTRIDGE FROM THE EYE. THERE WAS NO PATIENT INJURY; THE SURGEON WITHDREW THE CARTRIDGE TO PREVENT INJURY TO THE PATIENT¿S EYE. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THROUGH ADDITIONAL FOLLOW-UP, IT WAS LEARNED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACK-UP LENS (SAME MODEL AND SAME DIOPTER) FOR THE LEFT EYE. THERE WERE NO COMPLICATIONS AND THE PATIENT IS STABLE. IT WAS REPORTED THAT NO CARTRIDGE LUBRICATION WAS USED. THE DWELL TIME WAS 3 MINUTES OR LESS. WHEN ADVANCING THE LENS THE SCRUB TECHNICIAN MADE SMALL 1/4 TWISTS. IT WAS NOTED FROM THE SCRUB TECHNICIANS WHO WERE IN THE SURGERY THAT "THERE WERE NO PRINTED INSTRUCTIONS ON PROPER PROCEDURES FOR LOADING AND FILLING THE CHAMBER OF THE CARTRIDGE, NOR WHAT TO FILL THE CHAMBER OF TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18495431 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE RIGHT EYE IN A SECONDARY PROCEDURE DUE TO THE PATIENT HAVING POOR VISION AND VISUAL DISTURBANCES/DYSPHOTOPSIA POST SURGERY AND WANTED AN IOL EXCHANGE. THE PATIENT'S PRE IOL EXCHANGE VISUAL ACUITY (VA) WAS 20/40+1 DISTANCE UNCORRECTED AND BEST CORRECTED 20/25+2 WITH -0.50+0.50X097 MANIFEST REFRACTION, AND J3 @ 19¿ FOR NEAR. THE VA WAS VERY BLURRY PER PATIENT. THE PATIENT HAS ANGLE KAPPA FROM ITRACE ASSESSMENT THAT INDICATES INTOLERANCE FOR EXTENDED DEPTH OF FOCUS (EDOF)/DEFRACTIVE IOLS. A NON-JOHNSON AND JOHNSON LIGHT ADJUSTABLE LENS WAS IMPLANTED AS REPLACEMENT (+20.0 DIOPTER). THERE WAS NO PATIENT INJURY REPORTED. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. GOOD OUTCOME POST IOL EXCHANGE AND THE PATIENT IS HAPPY. THE PATIENT'S POST-OPERATIVE VA (POST-REPLACEMENT LENS) ON (B)(6) 2023 AT THE POST-OPERATIVE FOLLOW UP VISIT WAS 20/20 WITHOUT CORRECTION, AND 20/20 BEST CORRECTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 17066414 ↗