TECNIS IOL ZLB00 (REF ZLB00U0135)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474560543), received between Nov 8, 2016 and Sep 28, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Torn Material” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZLB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE BECAUSE OF REFRACTIVE ERROR. THERE WAS NO PATIENT INJURY. NO MEDICAL/ SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURES WERE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10597172 ↗
• InjuryDec 7, 2016Torn Material; Torn Material

  IT WAS REPORTED THAT AFTER INSERTION OF AN INTRAOCULAR LENS (IOL) INTO THE PATIENT'S EYE, THE SURGEON NOTICED THAT LENS WAS CHIPPED. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT WHILE THE LENS WAS BEING INJECTED, IT ALMOST SEEMED LIKE THE INJECTOR CHIPPED PART OF THE LENS OFF. THE SURGEON REMOVED THE LENS AND HAD TO ENLARGE THE INCISION. THERE WAS NO VITRECTOMY REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACKUP LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6150257 ↗
• InjuryNov 8, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZLB00 13.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO A MYOPIC OUTCOME. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND SUTURES REQUIRED. LENS WAS REPLACED WITH THE SAME MODEL LENS BUT A LOWER DIOPTER (13.0). THERE WAS NO PATIENT INJURY POST-OP.

  Patient problems: No Code Available

  MAUDE report 6087598 ↗