TECNIS IOL ZLB00 (REF ZLB00U0120)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474560512), received between Nov 29, 2016 and Apr 24, 2020 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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.

• MalfunctionApr 24, 2020Break; Break

  THIS REPORT SUMMARIZES <NOE> 2 </NOE> MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO LENS DAMAGE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9998836 ↗
• MalfunctionJan 30, 2020Break; Break

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO LENS DAMAGED. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9648414 ↗
• InjuryMay 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED BAD GLARE AFTER IMPLANTATION OF A ZLB00 12.0 DIOPTER INTRAOCULAR LENS (IOL) THAT WAS IMPLANTED IN HER LEFT EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6546442 ↗
• InjuryNov 29, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WAS EXPERIENCING HALOS AND GLARE AFTER IMPLANTATION OF A ZLB00 INTRAOCULAR LENS (IOL) IN THE LEFT EYE AND ZKB00 IOL IN THE RIGHT EYE. THE PATIENT STATED THAT SHE'S BEEN HAVING FUZZY RINGS/HALOS AROUND LIGHT. OVER TIME, THE FUZZY RINGS GOT BIGGER. HER NIGHT VISION IS COMPROMISED, HAS DIFFICULTY READING BECAUSE OF THE HALOS. THIS REPORT WILL CAPTURE THE ZLB00 12.0 DIOPTER IMPLANTED ON (B)(6) 2016 IN THE LEFT EYE AND A SEPARATE MDR WILL BE FILED FOR THE ZKB00 IOL.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 6134099 ↗