TECNIS IOL ZA9003 (REF ZA90030110)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474528833), received between Mar 25, 2020 and Sep 1, 2022 — classified as 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 18, 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.

• MalfunctionSep 1, 2022Break; Break

  IT WAS REPORTED THAT UPON FULL INSERTION OF THE INTRAOCULAR LENS (IOL) INTO THE RIGHT EYE, THE HAPTIC BROKE. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. IT WAS UNKNOWN IF PROCEDURE COMPLETED SUCCESSFULLY USING THE SAME OR DIFFERENT LENS. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15342232 ↗
• MalfunctionMar 25, 2020Contamination; Contamination

  IT WAS REPORTED THAT A CUSTOMER IS RETURNING THE ZA9003 INTRAOCULAR LENS (IOL) AND EMERALD CARTRIDGE DUE TO A COMPLAINT OF A "FILM" ON THE ZA9003. IT WAS STATED THAT THE CUSTOMER IS NOT SURE IF THE FILM IS ON THE LENS OR IF IT CAME FROM THE CARTRIDGE. IT WAS LEARNED THAT THE IOL HAD PATIENT CONTACT AND WAS REMOVED BUT WILL NOT BE RETURNED. NO OTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO THE IOL SUSPECT PRODUCT. A SEPARATE REPORT WILL BE SUBMITTED FOR THE CARTRIDGE SUSPECT PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9880057 ↗