TECNIS IOL ZA9003 (REF ZA90030275)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474529168), received between May 27, 2017 and Nov 21, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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.

• MalfunctionNov 21, 2023Break; Break

  IT WAS REPORTED THAT AFTER LENS IMPLANTATION, ON THE FIRST DAY AFTER SURGERY, DOCTOR FOUND THAT THE LENS HAPTIC IN THE PATIENT'S EYE WAS DAMAGED AND HAD TO BE EXPLANTED AND REPLACED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18187914 ↗
• MalfunctionApr 3, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE ZA9003 INTRAOCULAR LENS (IOL) WAS INSERTED INTO PATIENT'S OPERATIVE EYE, HOWEVER, HAD TO BE REMOVED AS IT WAS TORN. ANOTHER COMPETITOR LENS WAS USED AS THE REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE ZA9003, SN (B)(4)P. A SEPARATE REPORT WILL BE SUBMITTED FOR THE OTHER ZA9003 INTRAOCULAR LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16671285 ↗
• MalfunctionMar 31, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE ZA9003 INTRAOCULAR LENS WAS INSERTED INTO PATIENT'S OPERATIVE EYE, HOWEVER, HAD TO BE REMOVED AS IT WAS TORN. ANOTHER COMPETITOR LENS WAS USED AS THE REPLACEMENT. ADDITIONAL INFORMATION RECEIVED FROM THE FACILITY REVEALED THAT THERE WAS NO PATIENT INJURY AND NO OTHER MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16660178 ↗
• MalfunctionSep 17, 2021Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED THAT PARTIALLY INSERTED INTRAOCULAR LENS (IOL) FOR THE RIGHT EYE OF A PATIENT WAS REMOVED AND REPLACED IN THE SAME PROCEDURE DUE TO TRAILING HAPTIC NOT FOLDED. THE LENS DID CONTACT THE PATIENT EYE. THERE WERE NO MEDICAL/SURGICAL INTERVENTIONS REQUIRED. THE LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12488829 ↗
• MalfunctionMay 27, 2017Scratched Material; Scratched Material

  IT WAS REPORTED THAT A SCRATCH WAS NOTICED ON AN INTRAOCULAR LENS (IOL) WHEN OPENING THE LENS CASE. NO PATIENT CONTACT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6596224 ↗