TECNIS IOL DXW150 (REF DXW150U205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474762985), received between Nov 9, 2023 and Jan 21, 2025 — classified as 3 injuries.

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.

• InjuryJan 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MULTIFOCAL TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO DISSATISFACTION WITH ITS PERFORMANCE. THE LENS WAS REPLACED WITH AN ENHANCE TORIC DIU 150 +20.5. THE PATIENT EXPRESSED UNHAPPINESS WITH THE LENS, STATING IT DID NOT FEEL EFFECTIVE. ADDITIONAL INFORMATION REVEALED THAT THE PATIENT'S EXPERIENCED STARBURSTS FROM LIGHTS AND PRE-OPERATIVE VISION WAS 20/40, WHILE POST-OPERATIVE VISION IMPROVED TO 20/30. THE INTENDED AXIS PLACEMENT, AS RECOMMENDED BY THE CALCULATOR WAS 59 AND THE ACTUAL AXIS PLACEMENT DURING SURGERY WAS 60. THE POST-OPERATIVE AXIS OBSERVED WAS ALSO 60. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Flashers; Visual Impairment

  MAUDE report 21200959 ↗
• InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S LEFT EYE AS PATIENT CANNOT SEE TRAFFIC SIGNS. THE PATIENT CLOSES LEFT EYE TO DRIVE AT NIGHT, "CONCENTRIC CIRCLES, TURNS STARBURST, SHADOWS". ANOTHER JOHNSON & JOHNSON LENS OF DIFFERENT MODEL AND DIOPTER (DIU150, 20.0 D) WAS USED AS A REPLACEMENT. THE LENS WILL NOT BE RETURNED AS IT WAS DISCARDED AFTER EXPLANT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Flashers; Halo; Vitreous Floaters

  MAUDE report 18165378 ↗
• InjuryNov 9, 2023Adverse 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 OPERATIVE EYE. THE DXW150 IOL WAS REPLACED WITH A DIU150 20.5 DIOPTER IOL IN A SECONDARY SURGICAL PROCEDURE DUE TO COMPLAINTS OF GLARE AND HALOS. THERE WAS NO INCISION ENLARGEMENT AND NO VITRECTOMY. PATIENT OUTCOME POST-LENS EXCHANGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 18108221 ↗