TECNIS IOL ZLB00 (REF ZLB00U0170)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474560611), received between Jun 7, 2018 and Feb 12, 2020 — 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 16, 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.

• InjuryFeb 12, 2020Adverse 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 FROM PATIENT'S LEFT EYE REQUIRING INCISION ENLARGEMENT. NO SUTURE OR VITRECTOMY WERE REQUIRED. REASON FOR EXPLANT WAS NOT PROVIDED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9697429 ↗
• InjuryJan 7, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A MODEL ZLB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE BECAUSE OF MECHANICAL FAILURE OF LENS. INCISION WAS ENLARGED TO REMOVE THE IOL FROM THE EYE BUT VITRECTOMY AND SUTURES WERE NOT REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available; Visual Disturbances

  MAUDE report 9556476 ↗
• InjuryJul 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A MODEL ZLB00 17.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2019. IOL WAS EXPLANTED ON (B)(6) 2019 DUE TO COMPLAINT OF DYSPHOTOPSIA. IT WAS REPORTED NO OTHER SURGICAL INTERVENTION WAS REQUIRED. THE EXPLANTED LENS WAS REPLACED WITH A SYMFONY MODEL IOL 17.0 DIOPTER LENS. PATIENT OUTCOME WAS REPORTED AS GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8834399 ↗
• InjuryFeb 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS MULTIFOCAL INTRAOCULAR LENS (MODEL ZLB00 +17.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S LEFT EYE IN A SECONDARY PROCEDURE BECAUSE OF PATIENT EXPERIENCING DYSPHOTOPSIA. REPORTEDLY LENS FROM ANOTHER MANUFACTURER WAS USED AS REPLACEMENT LENS FOR THE PATIENT. THERE WAS INCISION ENLARGEMENT, VITRECTOMY PERFORMED DURING THE PROCEDURE. SUTURES WERE USED. THERE WAS NO OTHER MEDICAL INTERVENTION REQUIRED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 8351868 ↗
• InjuryJun 7, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZLB00 17.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO THE PATIENT DEVELOPING ANISOMETROPIA. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. REPORTEDLY, SURGICAL GLUE WAS USED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 18.5. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING GOOD POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7577294 ↗