TECNIS IOL ZMA00 (REF ZMA00U0215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474536838), received between Mar 13, 2018 and Mar 6, 2023 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE IOL (INTRAOCULAR LENS) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO DISLOCATION. THE IOL HAD BEEN PLACED IN THE SULCUS. THE EXPLANTED IOL WAS REPLACED WITH A NON-JOHNSON AND JOHNSON(JNJ) LENS. THE NON-JNJ LENS WAS PLACED IN THE ANTERIOR CHAMBER. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 16492647 ↗
• InjurySep 27, 2019Separation Problem; Separation Problem

  IT WAS REPORTED THAT LENS WAS EXPLANTED DUE TO MISSING HAPTIC WHEN LENS GOT IMPLANTED IN PATIENT RIGHT EYE. HAPTIC STAYED IN THE CARTRIDGE HINGE. THERE WAS INCISION ENLARGEMENT FROM 2.2 MM TO 3.0 MM. SUTURE WAS USED BECAUSE OF THE INCIDENT. VITRECTOMY WAS PERFORMED. PATIENT WAS DOING FINE POST-OP. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 9132198 ↗
• InjuryMay 17, 2019Product Quality Problem; Product Quality Problem

  IT WAS REPORTED INTRAOCULAR ZMA00 21.5 DIOPTER LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2019. THE LENS WAS EXPLANTED (B)(6) 2019 DUE TO THE SURGEON STATING THAT HE FELT THE LENS POWER DID NOT MATCH THE LENS DIOPTER IMPLANTED. IT WAS REPORTED THAT THE INCISION WAS ENLARGED AND SUTURE(S) WERE REQUIRED AND THE REPLACEMENT LENS WAS THE SAME MODEL BUT LOWER DIOPTER (23.0). PATIENT OUTCOME WAS REPORTED AS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 8618621 ↗
• InjuryMar 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZMA00 21.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S EYE. IT WAS LATER EXPLANTED DUE TO AN UNEXPECTED REFRACTIVE ERROR. THE REPLACEMENT LENS WAS A Z9003 20.5 DIOPTER LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 7336801 ↗