TECNIS IOL ZKU150 (REF ZKU150U205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474687035), received between Sep 22, 2021 and Feb 23, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Unstable” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED DIMINISHED VISION AND GLARE FOLLOWING THE IMPLANTATION OF A SINGLE PIECE PRELOADED TORIC INTRAOCULAR LENS (IOL) IN THE RIGHT EYE. THE VISUAL SYMPTOMS WERE FIRST OBSERVED DURING A POST-OPERATIVE EXAMINATION. THE ORIGINAL LENS WAS SUBSEQUENTLY EXPLANTED DURING A SECONDARY SURGERY AND WAS REPLACED WITH A JOHNSON AND JOHNSON IOL OF THE SAME MODEL WITH 19.5 DIOPTER. THE PRE-OPERATIVE BSCVA WAS 20/40 AND THE POST-OPERATIVE BSCVA WAS 20/15. DAILY ACTIVITIES WERE NOT AFFECTED. NO UNPLANNED SURGICAL INTERVENTIONS SUCH AS, INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY WERE REQUIRED. NO MEDICATION PRESCRIBED THAT WAS OUTSIDE OF THE STANDARD OF CARE AND NO REPORTED SURGICAL DELAYS. DIRECTIONS FOR USE WAS FOLLOWED. THE PATIENT HAS FULLY RECOVERED. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE PRE-OP REFRACTION WAS NOTED AS -1.50 +0.75 X60 AND THE POST-OP REFRACTION WAS A 0.25 +0.25 X40. THE PATIENT WAS NEITHER UNDER CORRECTED NOR OVER CORRECTED. THE INTENDED TARGET OF REFRACTION WAS PLANO SPHERE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24415819 ↗
• InjuryDec 3, 2024Unstable; Unstable

  IT WAS REPORTED THAT THE MONOFOCAL LENS WAS EXPLANTED FROM THE LEFT EYE DUE TO GLARE INTOLERANCE AND DISLOCATION OF THE IOL. THE LENS WAS REPLACED WITH NON-JOHNSON & JOHNSON LENSES. POST-OPERATIVELY, THE PATIENT IS DOING WELL AND THE REPLACEMENT LENS HAS HELPED ADDRESS CONCERNS. THERE WERE NO INJURIES. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 20837743 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT HAS BEEN REPORTED THE PATIENT EXPERIENCES BLURRY MID-RANGE VISION AND LACKS LONG-DISTANCE VISION, ALTHOUGH THEY CAN STILL READ. THEY STATED THERE IS A LOSS OF PERIPHERAL VISION IN BOTH EYES, BUT IT IS NOT AS SEVERE AS IN THE RIGHT EYE. IN THE RIGHT EYE (VISION IS WORSE) WITH A COMPLETE LOSS OF PERIPHERAL VISION, BLURRY MID-RANGE VISION, AND NO LONG-DISTANCE VISION. ADDITIONALLY, THE PATIENT HAS NO NIGHT VISION FOR DRIVING AND EXPERIENCES STARBURSTS AND HALOS. THE PATIENT REPORTED LOSS OF DEPTH PERCEPTION WHILE DRIVING AT NIGHT AND BEING BLINDED BY LIGHT. A SECOND OPINION HAS BEEN SOUGHT. PATIENT HAD BOTH LENSES REMOVED ON (B)(6) 2024 DUE TO DYSPHOTOPSIA, BOTHERSOME LACK OF PERIPHERAL VISION, BLURRINESS AT NIGHT WITH THE FIRST SYMPTOMS APPEARING 6 MONTHS AGO. THE PATIENT CURRENT STATUS IS BLURRY BUT GETTING BETTER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Flashers; Halo; Visual Disturbances

  MAUDE report 20023714 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL), MODEL ZKU150, WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO BLURRY VISION. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. ANOTHER JOHNSON & JOHNSON LENS MODEL ZKB00 (SAME DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO PATIENT INJURY. THE PATIENT'S POST-OPERATIVE OUTCOME WAS NOT AVAILABLE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 12516295 ↗