TECNIS IOL ZA9003 (REF ZA90030245)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 05050474529106), received between Mar 1, 2017 and Feb 13, 2025 — classified as 7 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2025Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THROUGH FOLLOW UPS, WE LEARNED THAT THE MATERIAL WAS DISCARDED AND THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21376588 ↗
• MalfunctionNov 27, 2024Break; Break

  IT WAS REPORTED THAT AFTER IMPLANTATION OF INTRAOCULAR LENS WITH MODEL ZA9003, BROKEN HAPTIC WAS FOUND. HOWEVER, SINCE IT WAS OBSERVED THAT THERE WAS NO ADVERSE EFFECT ON THE PATIENT'S VISION CURRENTLY, DOCTOR DECIDED NOT TO TAKE IT OUT AND WILL CONTINUE TO MONITOR FOR FURTHER OBSERVATION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20799967 ↗
• MalfunctionJul 22, 2023Break; Break

  IT WAS REPORTED THAT THE DOCTOR STARTED WITH A ZCB00 INTRAOCULAR LENS (IOL) AND AS THE LENS WAS ADVANCING, HE DECIDED TO CHANGE THE LENS. THERE WAS CARTRIDGE TIP CONTACT ONLY AND NO PATIENT INJURY WAS REPORTED. THE DOCTOR THEN DECIDED TO USE A ZA9003 IOL AND HAD TROUBLE ADVANCING IT. THE LENS SEEMED CURVED, WAS DAMAGED WHEN INSERTING IT INTO THE PATIENT¿S RIGHT EYE. ONLY CARTRIDGE TIP HAD PATIENT CONTACT. IT WAS CONFIRMED THAT THE LENS WAS INSPECTED PRIOR TO LOADING IT INTO THE CARTRIDGE AND WAS NOT DAMAGED. PER ACCOUNT, IT IS POSSIBLE THAT THE LENS DAMAGED IS DUE TO LOADING ERROR. IT WAS ALSO NOTED THAT THE LENS WAS NOT STUCK IN THE CARTRIDGE. THEY USED A BACKUP LENS OF THE SAME MODE AND DIOPTER TO COMPLETE THE PROCEDURE. THERE WERE NO SURGICAL AND/OR MEDICAL INTERVENTIONS REQUIRED. THE PATIENT IS DOING FINE, AND NO INJURY REPORTED. BOTH LENSES WERE DISCARDED AND WILL NOT BE RETURNED. NO FURTHER INFORMATION WAS PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17375695 ↗
• MalfunctionJul 3, 2023Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17253154 ↗
• MalfunctionJul 3, 2023Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17253152 ↗
• InjuryJun 8, 2023Material Fragmentation; Device Dislodged or Dislocated; Material Fragmentation; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE. IT WAS LEARNED THAT THE HAPTIC OF THE IOL LOST DURING INSERTION. FURTHER INFORMATION NOTED THAT THE TRAILING HAPTIC DETACHED AFTER THE OPTIC LEFT THE INJECTOR AND WAS ALREADY IN THE EYE. THE CASE WAS VERY COMPLICATED (POSTERIOR SYNECHIAE/POOR DILATION REQUIRING MALYUGIN RING; LOOSE ZONULES /CAPSULAR BAG REQUIRING A CAPSULAR TENSION RING; VERY DENSE CATARACT) - AS A RESULT, THE DOCTOR MADE THE DECISION TO LEAVE THE DEFECTIVE LENS IN AND NOT CAUSE FURTHER TRAUMA AT THAT TIME BY CUTTING OUT THE LENS. THE DOCTOR WANTED TO SEE HOW SHE DID AND SEE IF THE LENS WOULD REMAIN CENTERED. UNFORTUNATELY, IT DID NOT AND DECENTERED INFERIORLY CAUSING BLURRY VISION. THEREFORE, IOL EXCHANGE WAS DONE. ORIGINAL PLAN WAS TO REPLACE WITH ANOTHER ZA9003 BUT LOADING THAT LENS PROVED TO BE DIFFICULT (EVEN WITH A VERY EXPERIENCED TECH) AND THERE WAS CONCERN THE SAME THING WOULD HAPPEN AGAIN. THEREFORE, THE DOCTOR SWITCHED TO A NON-JOHNSON & JOHNSON 3-PIECE LENS OF +24.5 DIOPTER. THE PATIENT IS DOING WELL. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 17087762 ↗
• InjuryJan 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO A REFRACTIVE SURPRISE. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THE PATIENT HAS FULLY RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16109933 ↗
• MalfunctionOct 13, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE SURGEON IS SEEING SCRATCHES/STRIATIONS ALL OVER THREE TECNIS INTRAOCULAR LENSES (IOLS). THE SURGEON IS NOT SEEING THEM IN THE MICROSCOPE, BUT HIS DOCTOR OF OSTEOPATHY (ODS) ARE SEEING THEM IN THE SLIT LAMP. THE LENSES REMAIN IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED. THIS COMPLAINT FOLDER CAPTURES SERIAL (B)(4). THE OTHER SERIAL NUMBERS ARE BEING CAPTURED IN SEPARATE MEDWATCH REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12624401 ↗
• MalfunctionAug 10, 2021Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAPTIC BROKE UPON INSERTION INTO THE PATIENT'S OPERATIVE EYE. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS DURING THE SAME PROCEDURE. NO MEDICAL/ SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS ALRIGHT POST-OP. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12305454 ↗
• MalfunctionFeb 10, 2021Difficult to Fold, Unfold or Collapse; Use of Device Problem; Difficult to Fold, Unfold or Collapse; Use of Device Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD A LOADING AND FOLDING ISSUE. THE LENS WAS FULLY INSERTED IN THE RIGHT EYE AND REMOVED DURING THE SAME PROCEDURE. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11308450 ↗
• InjuryJan 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE (OS) DUE TO DYSPHOTOPSIA. AT EXPLANT, THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES DONE. THE EXPLANTED IOL WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL, LOWER DIOPTER POWER (23.5). NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 11213413 ↗
• InjuryJan 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING IMPLANTATION THERE WAS A PROBLEM AND A CAPSULAR RUPTURE OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; No Code Available

  MAUDE report 9583412 ↗
• MalfunctionMar 22, 2019Break; Break

  IT WAS REPORTED THAT LENS MODEL, ZA9003 HAD PACKAGING ISSUES WITH BENT HAPTIC. REPORTEDLY, THE DEVICE HAD CONTACT WITH THE PATIENT'S EYE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8446352 ↗
• MalfunctionJan 15, 2019Crack; Crack

  IT WAS REPORTED THAT THE OPTIC OF THE ZA9003 TECNIS MONOFOCAL IOL (INTRAOCULAR LENS) WAS OBSERVED CRACKED AFTER IMPLANTATION. THE LENS REMAINS IMPLANTED AND THE PATIENT'S VISION WAS REPORTED AS EXPECTED WHEN THE PATIENT WAS DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8247520 ↗
• InjuryOct 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZA9003 24.5 DIOPTER INTRAOCULAR LENS (IOL) WOULD NOT SIT PROPERLY IN THE CAPSULAR BAG DURING IMPLANTATION. THE LENS WAS REMOVED AND THE PATIENT WAS SENT HOME APHAKIC AS THE PATIENT'S ANATOMY COULD NOT HANDLE THE REPLACEMENT LENS. SUTURES WERE REQUIRED. THE PATIENT CAME BACK FOR A SECONDARY PROCEDURE AND HAD A SULCUS IOL IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6989349 ↗
• InjuryAug 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZA9003 24.5 DIOPTER INTRAOCULAR LENS (IOL) WAS REMOVED FROM EYE DUE TO AN INCREASE IN OCULAR PRESSURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Intraocular Pressure Increased; No Code Available

  MAUDE report 6769876 ↗
• InjuryAug 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZA9003 INTRAOCULAR LENS (IOL) WAS IMPLANTED AND REMOVED/EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6767351 ↗
• MalfunctionMar 1, 2017Device Contamination with Chemical or Other Material; Scratched Material; Device Contamination with Chemical or Other Material; Scratched Material

  IT WAS REPORTED THAT AFTER THE INSERTION OF ZA9003 INTO A PATIENT'S EYE, THE PHYSICIAN NOTICED DOTS/MARKS ON THE LENS. THE LENS WAS REMOVED AND REPLACED WITH A NEW LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6370211 ↗