TECNIS IOL ZMB00 (REF ZMB00U0130)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474535480), received between Jan 18, 2018 and Sep 1, 2020 — classified as 3 injuries.

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. How this data works · Data updated Oct 13, 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 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGERY CENTER REPORTED THAT A TECHNIC MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED, AND REPLACED IN A SECONDARY SURGICAL PROCEDURE FROM THE PATIENT'S LEFT EYE (OS) DUE TO BLURRY VISION. BEST CORRECTED VISUAL ACUITY (BCVA) 20/25 DURING POST OPERATION VISIT. THE REPLACEMENT LENS IS THE SAME MODEL, BUT LOWER DIOPTER (11.0). REPORTEDLY, THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT REPRESENTS THE LEFT (OS) EYE. A SEPARATE REPORT IS SUBMITTED FOR THE RIGHT (OD) EYE UNDER COMPLAINT FOLDER (CF) (B)(4).

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 10475453 ↗
• InjuryJan 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT CALLED TO REPORT THAT A ZMB00 13.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN HER LEFT EYE ON (B)(6) 2013. PATIENT ALSO HAD ANOTHER LENS, SAME MODEL IMPLANTED IN HER RIGHT EYE, (B)(6) 2013. SHE REPORTED THAT FOR ABOUT 2 YEARS SHE WAS PLEASED WITH THE LENSES; BUT FOR THE LAST YEAR, THEY ARE NOT AS EFFECTIVE AS IN THE BEGINNING. SHE REPORTED HAVING TO GET HER HEAD CLOSER AND CLOSER TO THE COMPUTER SCREEN, AND ON THE STREETS, SHE DOES NOT SEE THE NAMES OF THEM AS WELL AS BEFORE. AS PATIENT HAD BILATERAL LENS IMPLANTS; A REPORT WILL BE FILED FOR EACH EYE. THIS REPORT REPRESENTS THE PATIENT''S LEFT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 7204724 ↗
• InjuryJan 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT CALLED TO REPORT THAT A ZMB00 13.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN HER RIGHT EYE ON (B)(6) 2013. PATIENT ALSO HAD ANOTHER LENS, SAME MODEL IMPLANTED IN HER LEFT EYE, (B)(6) 2013. SHE REPORTED THAT FOR ABOUT 2 YEARS SHE WAS PLEASED WITH THE LENSES; BUT FOR THE LAST YEAR, THEY ARE NOT AS EFFECTIVE AS IN THE BEGINNING. SHE REPORTED HAVING TO GET HER HEAD CLOSER AND CLOSER TO THE COMPUTER SCREEN, AND ON THE STREETS, SHE DOES NOT SEE THE NAMES OF THEM AS WELL AS BEFORE. AS PATIENT HAD BILATERAL LENS IMPLANTS; A REPORT WILL BE FILED FOR EACH EYE. THIS REPORT REPRESENTS THE PATIENT''S RIGHT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 7204686 ↗