TECNIS IOL ZLU150 (REF ZLU150U210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474689381), received between Jul 14, 2021 and Jun 23, 2023 — classified as 2 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 16, 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.

• InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR PERFORMED TWO (2) CATARACT SURGERIES, ONE ON EACH OF THE PATIENT'S EYES. IT WAS STATED THAT THE PATIENT NEVER HAD PROBLEMS WITH HALOS AT NIGHT, AND DID NOT EVEN KNOW THE MEANING OF A HALO. HOWEVER, AFTER THE SURGERIES, THE PATIENT HAD MULTIPLE HALOS OF ALL COLORS OF THE STREET LIGHTS IN HER LINE OF SIGHT WHEN DRIVING AT NIGHT. THERE WERE SO MANY, THAT IT LEFT THE PATIENT IN AN EXTREMELY DANGEROUS SITUATION IF SHE WERE TO DRIVE AT NIGHT. THUS, THE PATIENT DID NOT DRIVE AT NIGHT SINCE ON (B)(6) 2022. THE PATIENT WAS INFORMED THAT SOMETIMES HALOS AND GLARES RESOLVE THEMSELVES WITH TIME; BUT PATIENT CLAIMED THAT HERS DID NOT. IT WAS LEARNED THAT EXPLANT OCCURRED LATER BUT NO OTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES EVENT FOR SUSPECT LENS IN RIGHT EYE (OD). EVENT FOR LEFT EYE (OS) IS DETERMINED TO BE NOT REPORTABLE AT THIS TIME.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 17191256 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE DUE TO MECHANICAL FAILURE. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THERE WERE NO ISSUE WITH THE LENS, BUT RATHER THE PATIENT WAS UNABLE TO ADJUST TO GLARE AND STARBURSTS ASSOCIATED WITH THE LENS. PATIENT ALSO STATED HER VISION SEEMED FUZZY. ANOTHER LENS OF DIFFERENT MODEL (SN_(B)(4)) WAS PLACED AS THE REPLACEMENT. PATIENT WAS DOING WELL POST EXPLANT PROCEDURE AND WAS HEALING AND PLEASED WITH THE VISION. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Blurred Vision; Flashers; Visual Disturbances

  MAUDE report 12169819 ↗