TECNIS IOL ZLB00 (REF ZLB00U0260)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474560796), received between Mar 29, 2017 and Sep 25, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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.

• InjurySep 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NON-PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL) HAS BEEN EXPLANTED AND THE IOL WAS TOSSED. THE ZLB00 LENS WAS EXPLANTED FROM THE PATIENTS LEFT EYE AND IMPLANTED A ZLU375 LENS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 17810193 ↗
• InjuryApr 13, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZLB00 26.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED FROM THE PATIENT'S EYE ON (B)(6) 2018, DUE TO THE PATIENT NOT BEING HAPPY WITH THEIR DISTANCE VISION. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS A ZKB00, A SMALLER 24.5 DIOPTER LENS. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7431273 ↗
• InjuryApr 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (MODEL ZLB00 +26.0 DIOPTER) WAS IMPLANTED IN THE LEFT EYE OF A FEMALE PATIENT ON (B)(6) 2017. THE LENS WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT WAS NOT SATISFIED WITH THE VISION. REPORTEDLY, THE PATIENT COMPLAINED OF HEADACHES. A MONOFOCAL LENS (MODEL ZCB00 + 26.0 DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE INCISION WAS NOT ENLARGED TO REMOVE THE MULTIFOCAL LENS AND A VITRECTOMY WAS NOT PERFORMED. THE PATIENT WAS REPORTED BEING BETTER WITH THE ZCB00 LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Headache; No Code Available

  MAUDE report 7404229 ↗
• InjuryMar 29, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A PHYSICIAN HAD TO PERFORM AN IOL EXCHANGE FOR A ZLB00 26.0 DIOPTER INTRAOCULAR LENS (IOL) DUE TO A DIOPTER SIZE ISSUE. THE LENS WAS REPLACED WITH THE SAME MODEL LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6444966 ↗