TECNIS IOL ZLB00 (REF ZLB00U0295)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474560864), received between Aug 29, 2016 and Dec 14, 2017 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 14, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZLB00 29.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE LEFT EYE (OS)OF THE PATIENT ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017, DUE TO INCORRECT LENS POWER FOR THE PATIENT. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR CAPSULE TEAR. THE LENS WAS REPLACED WITH THE SAME MODEL, BUT A DIFFERENT, SMALLER DIOPTER OF 27.0. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING WELL POST-OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7119669 ↗
• InjuryMar 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE BECAUSE THE MALE PATIENT WAS UNHAPPY WITH THE RESULTS. A DIFFERENT LENS WAS IMPLANTED, A MONOFOCAL MODEL ZCB00, THE DIOPTER SIZE WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6404891 ↗
• InjuryNov 11, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A PATIENT THAT SHE IS EXPERIENCING FILMY VISION CAUSING HER TO MISS WORK. PATIENT IS BEING TREATED FOR DRY EYES SINCE (B)(6) 2016, AND A POSSIBLE EXPLANT OF THE LENS IN THE FUTURE IS BEING CONSIDERED. THROUGH FOLLOW UP, IT WAS LEARNED THAT THE PATIENT HAD TWO ZLB00 INTRAOCULAR LENSES (IOL) IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT WILL CAPTURE THE ZLB00 IMPLANTED IN A RIGHT EYE. A SEPARATE MDR WILL BE FILED FOR THE ZLB00 IOL IMPLANTED IN LEFT EYE.

  Patient problems: Dry Eye(s); No Code Available; Visual Disturbances

  MAUDE report 6096284 ↗
• InjuryNov 11, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A PATIENT THAT SHE IS EXPERIENCING FILMY VISION CAUSING HER TO MISS WORK. PATIENT IS BEING TREATED FOR DRY EYES SINCE (B)(6) 2016, AND A POSSIBLE EXPLANT OF THE LENS IN THE FUTURE IS BEING CONSIDERED. THROUGH FOLLOW UP, IT WAS LEARNED THAT THE PATIENT HAD TWO ZLB00 INTRAOCULAR LENSES (IOL) IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT WILL CAPTURE THE ZLB00 IMPLANTED IN A LEFT EYE. A SEPARATE MDR WILL BE FILED FOR THE ZLB00 IOL IMPLANTED IN RIGHT EYE.

  Patient problems: Dry Eye(s); No Code Available; Visual Disturbances

  MAUDE report 6096238 ↗
• InjuryAug 29, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 29.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED IN A SECONDARY PROCEDURE. THERE WAS AN INCISION ENLARGEMENT AND THE LENS WAS REPLACED WITH ANOTHER ZLB00 LENS BUT A LOWER DIOPTER (24.0).

  Patient problems: No Code Available

  MAUDE report 5912676 ↗