TECNIS IOL ZMB00 (REF ZMB00U0140)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474535503), received between Nov 30, 2016 and Jan 10, 2018 — classified as 3 injuries, 1 malfunction.

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

• InjuryJan 10, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZMB00 14.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. HOWEVER, AN EXPLANT IS SCHEDULED FOR (B)(6) 2017 DUE TO REFRACTIVE ERROR. THE REPLACEMENT LENS WILL BE THE SAME MODEL, BUT DIFFERENT DIOPTER OF 12.0. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7181058 ↗
• InjuryJul 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT COMPLAINED ABOUT HALOS AND GLARE AFTER IMPLANTATION OF THE INTRAOCULAR LENS (IOL). THE IOL WAS EXPLANTED AND REPLACED DURING A SECONDARY SURGICAL PROCEDURE. THE INCISION WAS ENLARGED DURING THE REPLACEMENT. A VITRECTOMY WAS NOT PERFORMED. NO OTHER MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. PATIENT WAS DOING FINE WHEN DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: Halo; No Code Available

  MAUDE report 6688518 ↗
• InjuryMar 31, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL ZMB00, WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE BECAUSE THE MALE PATIENT HAD AN INTERMEDIATE DROP IN VISION. REPORTEDLY, THE LENS WAS REPLACED WITH A DIFFERENT MULTIFOCAL LENS, MODEL ZKB00, THE DIOPTER SIZE WAS NOT PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY WAS PERFORMED AND NO PATIENT POST-OP INJURY WAS REPORTED. THE LENS WAS DISCARDED BY THE CUSTOMER. REPORTEDLY, THERE WAS A PLAN TO EXPLANT THE LENS IN LATE 2016, BECAUSE OF THE VISUAL ISSUE. HOWEVER, THE PATIENT KEPT ON PUSHING THE DATE OFF UNTIL (B)(6) 2017, WHEN THE LENS WAS EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 6449969 ↗
• MalfunctionNov 30, 2016Break; Break

  IT WAS REPORTED THAT WHEN THE INTRAOCULAR LENS (IOL) WAS PLACED IN THE EYE AND THE SURGEON ROTATED, THE HAPTIC BROKE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 6134134 ↗