TECNIS IOL ZLB00 (REF ZLB00U0100)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474560475), received between Feb 7, 2017 and Mar 12, 2020 — classified as 3 injuries, 1 malfunction.

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

• InjuryMar 12, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED ZLB00 10.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2020. THE LENS WAS EXPLANTED ON (B)(6)2020 DUE TO COMPLAINT OF MECHANICAL FAILURE. IT WAS REPORTED THE INCISION WAS ENLARGED AND VITRECTOMY WAS PERFORMED HOWEVER THERE WAS NO PATIENT INJURY AND SUTURE(S) WERE NOT REQUIRED. THE LENS WAS REMOVED IN ONE PIECE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available; No Consequences Or Impact To Patient; Vitrectomy

  MAUDE report 9827625 ↗
• InjuryApr 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE ON (B)(6) 2018. IT WILL BE LATER EXPLANTED IN A SECONDARY SURGICAL PROCEDURE PLANNED FOR (B)(6) 2018, AND REPLACED WITH ANOTHER MANUFACTURER'S LENS. THE REASON FOR THE UPCOMING EXPLANT WAS NOT PROVIDED. REPORTEDLY, THERE WAS NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTIONS PERFORMED OR PLANNED DURING THE INITIAL SURGERY. THE PATIENT WAS REPORTED DOING FINE WHEN DISCHARGED. FURTHER, THE PATIENT'S DAILY ACTIVITIES ARE AFFECTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7465459 ↗
• InjuryJan 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 10.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018, BECAUSE THE PATIENT COMPLAINED OF HALOS AND WAS OVERALL DISSATISFIED WITH THE LENS THAT WAS IMPLANTED. THE SYMPTOMS ALSO SIGNIFICANTLY INTERFERED WITH REGULAR ACTIVITIES. THE LENS WAS REPLACED WITH THE SAME DIOPTER, BUT DIFFERENT MODEL Z9002. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED. ALSO, THERE WAS NO POST-OPERATIVE PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 7213419 ↗
• MalfunctionFeb 7, 2017Torn Material; Torn Material

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS TORN DURING INSERTION INTO THE PATIENT'S EYE. PATIENT CONTACT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6306323 ↗