TECNIS IOL ZA9003 (REF ZA90030120)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474528857), received between Feb 21, 2018 and Jul 17, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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.

• InjuryJul 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ZA9003 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). DURING A CONSULT APPOINTMENT, IT WAS REPORTED THE IOL WAS SUBLUXED/DISPLACED, THUS THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A AR40E 11.0 IOL. THERE WERE NO SUTURES DURING THE LENS EXCHANGE PROCEDURE HOWEVER, A VITRECTOMY WAS PERFORMED. THE IOL DIRECTIONS FOR USE WERE FOLLOWED. PATIENT PROGNOSIS POST LENS EXCHANGE WAS REPORTED AS FULLY RECOVERED. PATIENT INFORMATION CANNOT BE PROVIDED DUE TO PERSONAL DATA PRIVACY LEGISLATION/POLICY. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 22538442 ↗
• InjuryJul 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS NOT STABLE IN THE EYE. THE IOL WAS REMOVED AND REPLACED IN THE SAME PROCEDURE WITH A NON JNJ LENS. VITRECTOMY WAS REQUIRED. THE INCISION WAS ENLARGED AND SUTURES WERE USED. THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 17294354 ↗
• MalfunctionMay 21, 2021Material Fragmentation; Difficult to Advance; Material Fragmentation; Difficult to Advance

  IT WAS INITIALLY REPORTED THE INTRAOCULAR LENS (IOL) WAS BROKEN. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS PROVIDED CONFIRMING PARTIAL CONTACT WITH PATIENT AS THE DOCTOR ATTEMPTED TO INSERT THE IOL IN THE PATIENT'S OCULAR DEXTER (RIGHT EYE), AND THE HOOK BROKE OFF, THUS BREAKING THE LENS. THERE WAS NO PATIENT INJURY AND NO UNPLANNED SUTURE(S). IT IS UNKNOWN IF THE INCISION WAS ENLARGED, HOWEVER A PLANNED VITRECTOMY WAS PERFORMED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACK-UP LENS WITH THE SAME MODEL AND DIOPTER SIZE. THE DAMAGED LENS WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11861311 ↗
• MalfunctionFeb 27, 2019Break; Break

  IT WAS REPORTED THAT A ZA9003 12.0 INTRAOCULAR LENS (IOL) WAS EXCHANGED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IOL WAS DAMAGED DURING LOADING BUT NOT NOTICED UNTIL AFTER IT WAS IMPLANTED INTO THE LEFT EYE. THERE WAS NOT PATIENT INJURY, NO INCISION ENLARGEMENT AND NO VITRECTOMY PERFORMED. A NEW LENS OF THE SAME MODEL AND DIOPTER WAS IMPLANTED AND THE PATIENT WAS DOING GOOD POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8372816 ↗
• InjuryFeb 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZA9003 12.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. IT WAS LATER EXPLANTED DUE TO ANISOMETROPIA, WHICH LED TO ANISCORIA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7287879 ↗