TECNIS IOL ZLB00 (REF ZLB00U0300)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474560871), received between Jan 25, 2017 and Feb 25, 2019 — 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 18, 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.

• InjuryFeb 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS EXPERIENCING RESIDUAL MYOPIA (-1.25), HEADACHE AND BLURRED VISION AFTER THE IMPLANTATION OF +30.0 DIOPTER LENS MODEL, ZLB00 MULTIFOCAL IOL (INTRAOCULAR LENS) IN HER RIGHT EYE (OD). AS A RESULT, LENS WAS EXPLANTED AND REPLACED WITH SAME MODEL LENS LOWER DIOPTER (+29.0). IT WAS ALSO NOTED THAT THERE WERE NO PATIENT INJURY, NO INCISION ENLARGEMENT AND NO VITRECTOMY PERFORMED. PATIENT WAS STILL MYOPIC, BUT REPORTEDLY HAD BETTER VISION AND NO HEADACHES ANYMORE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Blurred Vision; Headache; No Code Available

  MAUDE report 8365346 ↗
• InjuryJan 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTATION OF A ZKB00 INTRAOCULAR LENS (IOL) THE PATIENT IS SEEING A HORIZONTAL LINE RUNNING THROUGH HIS VISION IN BOTH EYES. THE PATIENT ALSO HAS SIGNIFICANT GLARE IN BOTH EYES DESCRIBED AS HORIZONTAL GLARE THAT IS NOT TOLERABLE. THE PHYSICIAN PERFORMED A YTTRIUM-ALUMINUM-GARNET LASER (YAG) IN THE LEFT EYE; HOWEVER THIS DID NOT RESOLVE THE ISSUE COMPLETELY. HE NOTED THAT THE PATIENT WILL STILL HAVE THE ISSUE IN THE RIGHT EYE, SO HE PLANS TO PERFORM A LENS EXCHANGE ON THE RIGHT EYE. THE LENS REMAINS IMPLANTED AND WILL BE REPLACED WITH A NON-AMO MONOFOCAL DEVICE. THERE WERE NO PATIENT INJURY REPORTED FOR THIS EVENT. THE PHYSICIAN ALSO NOTED THAT THE PATIENT HAS A POSTERIOR CAPSULE OPACIFICATION (PCO) ON THE LEFT EYE ALSO BUT EXCHANGING THE LENS AFTER A YAG IS MORE CHALLENGING AND RISKY. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE PATIENT'S LEFT EYE AND A SEPARATE REPORT WILL BE FILED FOR THE LENS IMPLANTED IN THE PATIENT'S RIGHT EYE.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6278068 ↗