TECNIS IOL ZMA00 (REF ZMA00U0230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474536869), received between Sep 26, 2016 and Jun 27, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• 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 19628252 ↗
• MalfunctionOct 12, 2022Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) SPLIT AFTER INSERTION IN THE PATIENT'S LEFT EYE. ACCOUNT INDICATED THAT THE DIRECTIONS FOR USE WERE FOLLOWED. THE IOL WAS REMOVED DURING SAME PROCEDURE. ANOTHER JOHNSON AND JOHNSON LENS (MODEL ZMA00, 22.5 DIOPTER) WAS IMPLANTED. THERE WAS NO VITRECTOMY PERFORMED AND NO SUTURES WERE REQUIRED. PATIENT OUTCOME WAS PROVIDED AS TEMPORARILY IMPAIRED. DROPS WERE PRESCRIBED AS PART OF REGULAR STANDARD OF CARE POST SURGERY. THERE WAS NO PATIENT INJURY REPORTED. THE ORIGINAL IOL WAS DISCARDED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15592388 ↗
• InjuryAug 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS INTRAOCULAR LENS (IOL), MODEL ZMA00 23.0 DIOPTER, WAS EXPLANTED FROM THE PATIENT'S LEFT EYE ON (B)(6) 2017 AND REPLACED WITH A ZMA00 22.0 DIOPTER IOL DUE TO MYOPIC MISS. THE EXPLANTED LENS WAS NOT SAVED. ADDITIONAL INFORMATION NOT PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6793603 ↗
• InjuryOct 19, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COULD NOT TOLERATE THE HALOS AND FELT THEIR VISION WAS BLURRED IN COMPARISON TO THE FELLOW EYE WHICH HAS ANOTHER LENS IMPLANTED. THE LENS WAS REPLACED WITH A MONOFOCAL LENS. THE SURGERY WAS UNEVENTFUL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 6039055 ↗
• MalfunctionSep 26, 2016Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THERE WAS A FOLDING ISSUE WITH THE INTRAOCULAR LENS (IOL). THE LENS WAS FULLY IMPLANTED; HOWEVER, IT HAD TO BE REMOVED WITHIN SAME PROCEDURE AND REPLACED WITH ANOTHER LENS OF THE SAME MODEL. DURING FOLLOW UP, IT WAS REPORTED THAT AFTER THE LENS WAS INSERTED, IT DID NOT UNFOLD PROPERLY. THE LENS WAS REMOVED WITH NO INCISION ENLARGEMENT OR PATIENT INJURY. THERE WERE NO COMPLICATIONS WITH THE REPLACEMENT PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5978173 ↗