TECNIS IOL ZA9003 (REF ZA90030260)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474529137), received between May 1, 2017 and Sep 26, 2023 — classified as 5 injuries, 3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT FELL AND REQUIRED STITCHES MONTHS AGO. THE FALL RESULTED IN PSEUDO-PHACODENESIS. THE TECNIS NON-PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED IN A SECONDARY PROCEDURE. AN UNPLANNED VITRECTOMY WAS PERFORMED. THERE WAS NO UNPLANNED INCISION ENLARGEMENT AND NO UNPLANNED SUTURES. THE DIRECTIONS FOR USE WERE FOLLOWED. THE EXPLANTED LENS WAS REPLACED WITH SAME MODEL +18.5 D LENS. PATIENT WAS FULLY RECOVERED.

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

  MAUDE report 17819635 ↗
• MalfunctionAug 12, 2021Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A ZA9003 MODEL INTRAOCULAR LENS(IOL) WAS FULLY INSERTED AND REMOVED DURING THE SAME PROCEDURE FROM PATIENT'S OPERATIVE EYE DUE TO STUCK HAPTIC. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12316858 ↗
• MalfunctionJun 17, 2021Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT A (B)(4) MODEL INTRAOCULAR LENS(IOL) HAPTIC WAS SEEN AS DISTORTED WHILE DOCTOR WAS INSERTING THE LENS INTO PATIENT'S RIGHT EYE. THE IOL WAS PARTIALLY INSERTED AND WAS REMOVED FROM EYE DURING THE SAME PROCEDURE. PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS OF SAME MODEL AND DIOPTER. THERE WAS NO PATIENT INJURY AND NO MEDICAL/ SURGICAL INTERVENTION SUCH AS INCISION ENLARGEMENT OR VITRECTOMY WERE REQUIRED BUT SUTURES WERE DONE. ADDITIONAL DETAILS RECEIVED STATES THAT THE SUTURES WERE PLACED AS A STANDARD OF CARE FOR THIS PARTICULAR DOCTOR, AS ALL OF HIS CATARACT PROCEDURES REQUIRE SUTURE. PATIENT WAS DOING FINE POST-OP. SUSPECT PRODUCT WAS DISCARDED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12022119 ↗
• InjuryAug 31, 2020Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD A LOADING ISSUE, THE IOL DID NOT BEND LIKE A TACO. IT WAS NOTED TO BEND LIKE A TENT. THE LENS WAS TOO THICK AND HAPTIC GOT BENT. THE IOL WAS FULLY INSERTED AND REMOVED FROM THE LEFT EYE DURING THE SAME PROCEDURE AND IT WAS REPLACED WITH THE BACK-UP IOL, SAME MODEL AND SAME DIOPTER POWER, AND ONE SUTURE WAS REQUIRED. NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 10475363 ↗
• InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZA9003 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENTS RIGHT EYE DUE TO ASTIGMATISM. THE GOAL WAS TO ACHIEVE PLANO BUT RESULTED IN -0.37. THE EXPLANTED IOL WAS REPLACED WITH A TORIC LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8949940 ↗
• InjuryOct 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS MONOFOCAL INTRAOCULAR LENS (MODEL ZA9003 +26.0 DIOPTER) HAD PATIENT CONTACT. REPORTEDLY THERE WAS A BROKEN CAPSULE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 7987877 ↗
• InjuryMay 19, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (MODEL ZA9003 +26.0 DIOPTER) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 AS THE SURGEON CHANGED THE LENS POWER. THE INCISION WAS NOT ENLARGED. THE PATIENT WAS REPORTED AS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7528315 ↗
• MalfunctionMay 1, 2017Scratched Material; Scratched Material

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

  Patient problems: No Patient Involvement

  MAUDE report 6535825 ↗