TECNIS IOL ZMA00 (REF ZMA00U0210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474536821), received between Nov 16, 2016 and Jul 28, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjuryJul 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN INTRAOCULAR LENS WAS EXPLANTED FROM THE PATIENT'S LEFT EYE. THERE WAS INCISION ENLARGED WITH 2 SUTURES, NO VITRECTOMY. THERE WAS ALLEGATION ON THE JOHNSON & JOHNSON LENS. THE PATIENT WAS HAPPY, NO VISUAL ISSUES HOWEVER, THE REASON FOR EXPLANT WAS WHEN THE DOCTOR WAS CHECKING THE PATIENT DURING HIS FOLLOW-UP, SHE CONFIRMED THAT THE LENS WAS A LITTLE DISPLACED/ TILTED. THE DOCTOR NOTICED THAT CAPSULAR SUPPORT WAS NOT GOOD. THE DOCTOR CONSULTED OTHER DOCTORS AND THEY ALL AGREED THAT SHE EXPLANT THE ORIGINAL LENS THIS TIME WHILE PATIENT IS STILL YOUNG BECAUSE IT MAY BECOME COMPLICATED IF DOCTOR EXPLANTS IT LATER WHEN THE PATIENT BECOMES OLDER. THE DOCTOR THEN EXPLANTED THE LENS AND REPLACED IT WITH A NON-JOHNSON AND JOHNSON LENS. PATIENT IS WELL POST-EXPLANT. NO VISUAL COMPLAINTS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Zonular Dehiscence

  MAUDE report 17420083 ↗
• InjuryMar 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZMA00 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE (OD) BECAUSE PATIENT WAS UNHAPPY WITH THE INTERMEDIATE AND NEAR VISUAL ACUITY. THE LENS WAS REPLACED WITH A MODEL ZKB00 IOL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9840664 ↗
• InjuryNov 16, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZMA00 INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO A PATIENT EXPERIENCING HALOS AND GLARE. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES REQUIRED. LENS WAS REPLACED WITH A Z9002 21.0 DIOPTER IOL.

  Patient problems: Halo; No Code Available

  MAUDE report 6105084 ↗