TECNIS IOL ZLB00 (REF ZLB00U0145)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474560567), received between Sep 20, 2016 and Dec 13, 2020 — classified as 7 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORT OF EXPLANT OF LENS IMPLANT FROM THE PATIENT¿S LEFT EYE DUE TO REFRACTIVE ERROR IN CALCULATION. IT WAS REPLACED WITH THE SAME MODEL NUMBER BUT HIGHER DIOPTER POWER (15.5) LENS. IT WAS LEARNED THAT THE SUSPECT PRODUCT WAS DISCARDED. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. THE PATIENT WAS WELL POST-OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10998891 ↗
• InjuryOct 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THE IOL WAS EXPLANTED AND REPLACED WITH A DIFFERENT LENS MODEL (ZXR00) AND DIFFERENT DIOPTER SIZE (14.0). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10654176 ↗
• InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO CONSTANT HALOS AND DIFFICULTY READING SMALL PRINT. NO SURGICAL INTERVENTION WAS REQUIRED. REPORTEDLY, PATIENT IS DOING FINE POST-EXCHANGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 9539597 ↗
• InjuryAug 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS 1 MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL ZLB00 14.5 DIOPTER, WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE ON (B)(6) 2017 DUE TO POOR INTERMEDIATE AND READING VISION. THE REPLACEMENT LENS WAS A MODEL ZMB00 15.5 DIOPTER. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR COMPLICATIONS. THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 6819675 ↗
• InjuryDec 13, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 14.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO PATIENT EXPERIENCING GLARES. THE LENS WAS REPLACED WITH A ZCB00 IOL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6168706 ↗
• InjuryDec 2, 2016Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZLB00 14.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO PATIENT'S UNRESOLVED REFRACTIVE ERROR AND DISSATISFACTION WITH THE CURRENT IMPLANT POWER LENS. IMPLANT WAS REMOVED IN ONE PIECE. NO COMPLICATION OCCURRED DURING EXPLANTATION. ANOTHER TECNIS IMPLANT POWER LENS WAS USED AND REPLACED THE EXPLANTED LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6142520 ↗
• InjurySep 20, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 14.5 DIOPTER INTRAOCULAR LENS WAS EXPLANTED DUE TO A HYPERMYOPTIC OUTCOME. THE LENS WAS REPLACED WITH ANOTHER ZLB00 LENS OF A LOWER DIOPTER (13.5). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 5962210 ↗