TECNIS IOL ZA9003 (REF ZA90030265)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474529144), received between Sep 28, 2016 and Feb 3, 2022 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE SURGEON NOTICED THAT THE INTRAOCULAR LENS (IOL) WAS SCRATCHED WHEN IT WAS INSIDE THE PATIENT'S OPERATIVE EYE. IT WAS INDICATED, POSSIBLY LOADED IMPROPERLY. THE LENS WAS CUT OUT AND ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13447608 ↗
• MalfunctionDec 18, 2020Break; Break

  IT WAS REPORTED THAT A ZA9003 MODEL INTRAOCULAR LENS (IOL) WAS SCRATCHED AND LENS WAS REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER LENS OF SAME MODEL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11041406 ↗
• InjuryDec 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZA9003 INTRAOCULAR LENS (IOL) HAD TO BE REMOVED UPON INSERTION, BECAUSE THE PATIENT'S POSTERIOR CAPSULAR TEAR REQUIRING ANTERIOR VITRECTOMY. THE CUSTOMER INDICATED THAT PATIENT'S CAPSULAR BAG HAS INADEQUATE SUPPORT FOR A SULCUS FIXATED IOL AND THREE PIECE LENS WAS INSERTED BUT WAS TILTING; THEREFORE, IOL WAS REMOVED SUCCESSFULLY. A SUTURE WAS REQUIRED FOR CLOSURE AND PATIENT WAS SENT TO A RETINAL SPECIALIST FOR FURTHER EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; No Code Available; Vitrectomy

  MAUDE report 9450209 ↗
• MalfunctionJun 2, 2018Break; Break

  IT WAS REPORTED VIA RETURNED PRODUCT RECEIPT THAT THE HAPTIC OF A MODEL ZA9003 INTRAOCULAR LENS (IOL) WAS BENT. PATIENT INVOLVEMENT AND OUTCOME WERE NOT PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7563645 ↗
• MalfunctionOct 6, 2016Entrapment of Device; Failure to Unfold or Unwrap; Entrapment of Device; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT DURING IMPLANTATION, THE INTRAOCULAR LENS (IOL) DID NOT UNFOLD PROPERLY IN THE PATIENT'S EYE. THE HAPTIC GOT CAUGHT IN THE PUPIL AND THE SURGEON HAD TO CUT THE LENS OUT OF THE EYE. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR PATIENT INJURY REPORTED. A DIFFERENT LENS WAS INSERTED IN THE ANTERIOR CHAMBER WITH NO OTHER COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6006314 ↗
• MalfunctionSep 28, 2016Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE HAPTIC GOT CAUGHT IN THE PUPIL AND HAD TO BE CUT OUT AND CHANGED TO AN ANTERIOR LENS. DURING FOLLOW-UP, THE COMPLAINT REPORTER STATED THAT AFTER THE LENS WAS INSERTED INTO THE EYE, IT DID NOT UNFOLD PROPERLY. A HAPTIC GOT CAUGHT IN THE PUPIL. THEREFORE, THE DOCTOR HAD TO CUT THE LENS TO REMOVE IT. THE LENS WAS REMOVED WITH NO INCISION ENLARGEMENT, VITRECTOMY OR PATIENT INJURY. A DIFFERENT LENS WAS INSERTED IN THE ANTERIOR CHAMBER WITH NO OTHER COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5982409 ↗