TECNIS IOL ZLU150 (REF ZLU150U205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474689374), received between Feb 7, 2023 and May 19, 2025 — classified as 2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2025Contamination; Contamination

  SOME TYPE OF SPECK ON THE INTERNAL PART OF THE ZLU150 MODEL INTRAOCULAR LENS (IOL). THE DOCTOR VIGOROUSLY PERFORMED VISCOELASTIC REMOVAL AND TRIED TO CLEAN EVERYTHING OUT OF THE PATIENT'S EYE, BUT THE ITEM STILL REMAINED ON THE LENS. THE SURGERY WAS COMPLETED DURING THE SAME PROCEDURE. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS NOT REMOVED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22048938 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR IMPLANTED A PATIENT WITH A ZLU150 20.5 D INTRAOCULAR LENS. PATIENT HAD IT EXPLANTED DUE TO COMPLAINTS OF GLARE AND HALO. PATIENT WAS THEN IMPLANTED WITH A ZCU 150 21.0D. NO COMPLICATIONS WERE OCCURRED FOR BOTH PROCEDURES. MEDICAL INTERVENTION OT WAS PROVIDED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 16865564 ↗
• InjuryFeb 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXCHANGED IN A SECONDARY SURGERY DUE TO DISABLING GLARE IN THE RIGHT EYE. THE ISSUE WAS OBSERVED DURING A POST-OPERATIVE EXAMINATION. THE PATIENT'S PRE-OPERATIVE VISUAL ACUITY (VA) WAS 20/30 AND POST-OPERATIVE VA WAS 20/30. THERE WAS NO DELAY IN PROCEDURE. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIFFERENT MODEL, DIU150, SAME CYLINDER AND DIOPTER). THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURE REQUIRED. THERE WAS NO PATIENT INJURY. THE GLARE IS MUCH IMPROVED POST-OPERATIVELY, BUT NOT COMPLETELY RESOLVED. THE PATIENT IS MUCH HAPPIER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 16314890 ↗