TECNIS IOL ZMA00 (REF ZMA00U0225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474536852), received between Sep 20, 2022 and Jun 27, 2024 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ASKING IF WE KNEW OF ANY EYE COVERS (LIKE GLASSES) TO COVER HIS EYES AND ALLOW HIM TO SEE WHILE WELDING, AS HE IS A WELDER BY PROFESSION. BOTH EYES WERE IMPLANTED WITH AN INTRAOCULAR LENS (IOL) IN 2009. THE PATIENT'S VISION IS GREAT DURING THE DAY, BUT THERE IS GLARE WHEN VIEWING LIGHTS AT NIGHT, AND WHILE WELDING. PATIENT INDICATED THAT WHEN STRIKING AN ARC WHILE WELDING, IT BECOMES SO DISTORTED THAT THE METAL BEING WORKED ON CAN NO LONGER BEING SEEN. THE PATIENT IS INQUIRING IF THERE ARE ANY GLASSES OR PRODUCTS THAT COULD ALLEVIATE THE PROBLEM. THE VISUAL ISSUES ARE BEING DESCRIBED AS A PLUMAGE. IT WAS NOTED THAT THE PATIENT CAN STILL WORK ALTHOUGH THEY ARE CLAIMING NOT REALLY SEEING ENOUGH. AFTER ABOUT 14 MONTHS FROM INITIAL REPORT, PATIENT CALLED BACK TO PROVIDE PRODUCT IDENTIFIERS. THE PATIENT INDICATED STILL SEEING SPARKLES AT NIGHT WHICH BLOCKS THE VISION. THEREFORE, THE PATIENT CLAIMED NOT WANTING TO DRIVE AT NIGHT ANYMORE. THE PATIENT DOES NOT WORK AS A WELDER ANYMORE AS HE HAS ALREADY STOPPED WELDING BUT DID NOT SAY WHEN HE STOPPED WORKING AS A WELDER. THE PATIENT SAID THAT HE STILL WELDS BUT ONLY FOR HIMSELF, THAT IS WHY HE REALLY WAN

  Patient problems: Visual Disturbances

  MAUDE report 19628399 ↗
• InjurySep 20, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S LEFT EYE DUE TO DECENTERED LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear

  MAUDE report 15458485 ↗