TECNIS IOL ZA9003 (REF ZA90030180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 05050474528970), received between Sep 13, 2016 and Feb 24, 2025 — classified as 27 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (14 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2025Break; Break

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) HAD A DAMAGED HAPTIC. ONE HAPTIC GOT MESSED UP AND IT TOUCHED THE PATIENT. THE LENS WAS INSERTED AND REMOVED DURING THE SAME PROCEDURE. THE SURGERY WAS COMPLETED WITH ANOTHER JOHNSON AND JOHNSON LENS MODEL: DCB00 18.0 DIOPTER SERIAL#: (B)(6). THE CASE WAS COMPLETED WITH NO ISSUES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21447697 ↗
• InjuryDec 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NON PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO VISUAL DISTURBANCES. THE ISSUE WAS FIRST IDENTIFIED DURING THE POST-OPERATIVE EXAMINATION. THE LENS WAS INSERTED AND THE PATIENT EXPERIENCED TEMPORARY IMPAIRMENT, AFFECTING THEIR ABILITY TO PERFORM DAILY ACTIVITIES. THE LENS WAS EXPLANTED IN THE SECONDARY PROCEDURE AND REPLACED WITH A NON JNJ LENS. THE PATIENT HAD FULLY RECOVERED. THERE WAS NO UNPLANNED VITRECTOMY OR INCISION ENLARGEMENT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 21049093 ↗
• InjuryDec 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  UVEITIS¿GLAUCOMA¿HYPHEMA (UGH) SYNDROME DUE TO DISLOCATION OF THE NON PRE-LOADED ZA9003 MODEL INTRAOCULAR LENS (IOL) WAS REPORTED AFTER IT'S IMPLANTATION IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND THE PATIENT WAS LEFT APHAKIC AS NO REPLACEMENT IOL WAS IMPLANTED. DURING THE LENS EXCHANGE PROCEDURE, THERE WERE NO SUTURES HOWEVER AN UNPLANNED VITRECTOMY WAS PERFORMED. THE FOLLOWING ARE ALL UNKNOWNS: WHETHER THE PATIENT¿S DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED, INCISION ENLARGEMENT, MEDICATION PRESCRIBED (OUTSIDE OF STANDARD CARE), OR IF MEDICAL ATTENTION WAS REQUIRED. THE IOL DIRECTIONS FOR USE WERE FOLLOWED. BOTH FULLY RECOVERED AND UNKNOWN WERE PROVIDED AS ANSWERS FOR PATIENT STATUS. THE IOL DIRECTIONS FOR USE WERE FOLLOWED. PATIENT INFORMATION CANNOT BE PROVIDED DUE TO PERSONAL DATA PRIVACY LEGISLATION/POLICY. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 20839844 ↗
• MalfunctionNov 13, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) TRAILING HAPTIC WAS MISSING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20679619 ↗
• MalfunctionMay 9, 2024Break; Break

  IT WAS REPORTED THAT THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE SULCUS, AND THEN HAD TO BE REMOVED DUE TO KINKED HAPTIC. THE ISSUE WAS NOTICED AFTER INSERTION OF THE LENS. THERE WERE NO PATIENT ISSUES AND THERE WAS NO VISUAL IMPACT OR SYMPTOMS.THE ISSUE DID NOT SIGNIFICANTLY INTERFERE WITH DAILY ACTIVITIES. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED OR PLANNED. THE PATIENT IS FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19283004 ↗
• InjuryDec 19, 2023Break; Difficult to Fold, Unfold or Collapse; Break; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) DURING IMPLANTATION, HAD THE FRONT HAPTIC BENT IN CARTRIDGE AND WAS NOT STABLE IN EYE. THERE WAS A 30 MINUTE DELAY IN PROCEDURE. THERE WAS NO UNPLANNED VITRECTOMY REPORTED, BUT THERE WAS INCISION ENLARGEMENT AND SUTURES PERFORMED. NO OUTSIDE OF STANDARD CARE MEDICATION WAS PRESCRIBED. IT WAS NOTED THAT THE IOL WAS PLACED INTO THE PATIENT¿S EYE HOWEVER, WITH THE FRONT HAPTIC BENT, THE LENS WOULD NOT UNCURL IN THE EYE SO IT WAS REMOVED AND A BACK UP LENS, MODEL ZA9003 WAS USED. THE PATIENT FULLY RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 18361298 ↗
• InjuryJul 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT ZA9003 INTRAOCULAR LENS WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO GASH AND VISUAL DISTURBANCES. ZA9003 LENS WAS REPLACED WITH LENS FROM ANOTHER MANUFACTURER SUCCESSFULLY. THERE WAS NO PATIENT INJURY AND MEDICAL OR SURGICAL INTERVENTIONS WERE NOT REQUIRED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury; Visual Disturbances

  MAUDE report 17317218 ↗
• InjuryJun 1, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE BACK-UP INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S OCULAR DEXTER (RIGHT EYE). THE PATIENT RETURNED FOR IOL REPOSITIONING ON (B)(6) 2023, THE IOL WAS NOT REPLACED. THERE WERE NO VISUAL ISSUES REPORTED BY THE PATIENT. PATIENT OUTCOME WAS REPORTED AS DONG WELL. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 17043615 ↗
• InjuryMar 13, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT ZA9003 INTRAOCULAR LENS WAS IMPLANTED AND REMOVED FROM THE PATIENTS LEFT EYE ON THE SAME DAY DUE TO LENS SCRATCH WHICH WAS OBSERVED AFTER THE INSERTION. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE ZA9003 LENS WAS REMOVED AND REPLACED IN THE SAME PROCEDURE WITH ANOTHER ZA9003 18.00. THERE WAS NO PATIENT INJURY AND INCISION ENLARGEMENT. PATIENT HAS RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16534937 ↗
• MalfunctionDec 12, 2022Break; Break

  IT WAS REPORTED THAT THE LEAD HAPTIC WAS DISCOVERED TO BE BENT AFTER FULL INSERTION INTO THE EYE. THE INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED WITH A BACK UP (MODEL UNKNOWN). THERE WAS NO REPORTED PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15963194 ↗
• InjuryNov 28, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S OPERATIVE EYE AS IT DISLOCATED. ANOTHER LENS OF SAME MODEL BUT OF SLIGHTLY LOWER DIOPTER WAS USED AS THE REPLACEMENT. NO OTHER INTERVENTION WAS REQUIRED AND THE PATIENT HAD FULLY RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 15874827 ↗
• MalfunctionNov 4, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS INSERTED AND REMOVED IN THE SAME PROCEDURE. THE REASON FOR THE REMOVAL WAS NOT SPECIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15739641 ↗
• MalfunctionJul 25, 2022Break; Break

  IT WAS REPORTED THAT DURING IMPLANTATION/APPLICATION THE INTRAOCULAR LENS (IOL) HAPTIC (LEG) WAS BROKEN. PRODUCT AVAILABILITY IS UNKNOWN AND NO FURTHER DETAILS ARE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15094633 ↗
• MalfunctionJun 3, 2022Break; Break

  IT WAS REPORTED THAT A DEFECT WAS OBSERVED ON THE INTRAOCULAR LENS (IOL) UPON INSERTION IN THE PATIENT¿S LEFT EYE. ACCOUNT INDICATED THAT THE IOL WAS REMOVED AND REPLACED IN THE SAME PROCEDURE. THE REPLACEMENT IOL WAS OF THE SAME MODEL AND DIOPTER POWER. NO PATIENT INJURY WAS NOTED AND NO MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14594805 ↗
• InjuryFeb 11, 2022Break; Break

  IT WAS REPORTED THAT THE LENS HAPTIC BROKE WHEN THE DOCTOR IMPLANTED THE INTRAOCULAR LENS (IOL) INTO THE PATIENT'S EYE. THE LENS WAS REMOVED AND REPLACED BY A SECOND LENS WHOSE HAPTIC ALSO BROKE. THE SECOND LENS WAS REMOVED AND THE PATIENT WAS LEFT APHAKIC. A REPLACEMENT LENS WOULD BE PLANNED IN THE NEAR FUTURE. ACCOUNT INDICATED THAT THERE WAS POSTERIOR CAPSULE RUPTURE AND THE CORNEA WOUND WAS EXTENDED TO REMOVE THE EACH OF THE LENSES. IT WAS PROVIDED THAT THE CORNEA WOUND WAS SUTURED AFTER THE REMOVAL OF THE SECOND LENS. THE IMPLANTATION AND EXPLANTATION OF BOTH LENSES PROLONGED THE SURGERY TIME. ACCOUNT PROVIDED THAT THE PATIENT ALSO SUFFERED FROM BLURRY VISION DUE TO THE TWO DEFECTIVE LENSES. VISION PRE-OPERATIVE PROVIDED AS LIGHT PERCEPTION AND VISION POST-OPERATIVE PROVIDED AS COUNTING FINGERS. THE PATIENT WAS REPORTEDLY STABLE POST SURGERY. NO FURTHER INTERVENTIONS WERE REPORTED AND NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE FIRST LENS IN USE FOR THIS CASE. A SEPARATE REPORT IS BEING SUBMITTED FOR THE SECOND LENS INVOLVED.

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

  MAUDE report 13518891 ↗
• MalfunctionAug 13, 2021Break; Break

  IT WAS REPORTED THAT THE TECNIS INTRAOCULAR LENS (IOL) WAS FULLY INSERTED, BUT HAD TO BE REPLACED DUE TO A BENT/BROKEN HAPTIC. THERE WAS PATIENT INVOLVEMENT AND NO INJURY REPORTED. PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12321298 ↗
• InjuryAug 12, 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/EXCHANGED FROM THE PATIENT'S OPERATIVE EYE DUE TO DECREASE IN DISTANCE VISUAL ACUITY (DVA), HYPEROPIC POST-OPERATIVELY. THE EXPLANTED IOL WAS REPLACED WITH ANOTHER ZA9003 LENS, BUT HIGHER DIOPTER 19.5. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES WERE REQUIRED. THE PATIENT'S PRE-OP VISUAL ACUITY (VA) 20/30, POST-OP VA 20/50. NO OTHER INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 12316856 ↗
• MalfunctionMay 27, 2021Break; Break

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) HAPTIC WAS BENT AND THERE WAS CONTACT WITH THE PATIENT'S OPERATIVE EYE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11898868 ↗
• InjuryFeb 18, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A ZA9003 MODEL INTRAOCULAR LENS(IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE AS THE LENS WAS SLIGHTLY DECENTERED AND PATIENT COMPLAINED OF BLURRY VISION AND ALSO SEEING THE EDGE OF LENS. INCISION ENLARGEMENT AND VITRECTOMY WERE NOT PERFORMED BUT SUTURES WAS DONE AS A PRECAUTION. THIS EVENT WAS OBSERVED DURING POST OPERATIVE EXAMINATION. ADDITIONAL DETAILS FROM FOLLOW UP STATES THAT THERE WAS NO PATIENT INJURY. THE REPLACEMENT LENS USED IS A SAME MODEL BUT DIFFERENT DIOPTER LENS. PATIENT WAS DISCHARGED SUCCESSFULLY WITHOUT ANY COMPLAINTS. SUSPECT PRODUCT IS NOT BEING RETURNED. PATIENT/USER OUTCOME: VISUAL ACUITY PRE-OPERATIVE: 20/30, VISUAL ACUITY POST-OPERATIVE: 20/30. NO FURTHER INFORMATION PROVIDED.

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

  MAUDE report 11344290 ↗
• InjuryFeb 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS INSERTED IN THE PATIENT'S OPERATIVE EYE AND THERE WAS AN AVULSION. THE INCISION WAS ENLARGED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 11309541 ↗
• InjuryDec 17, 2020Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD LOADING ISSUES/BENT HAPTIC. APPARENTLY, WRONG CARTRIDGE WAS USED. IOL WAS REMOVED AND REPLACED WITH BACK-UP IOL REQUIRING INCISION ENLARGEMENT. NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 11033639 ↗
• InjuryDec 17, 2020Break; Use of Device Problem; Device Handling Problem; Break; Use of Device Problem; Device Handling Problem

  IT WAS REPORTED THAT THERE WERE ISSUES WITH AN INTRAOCULAR LENS (IOL). REPORTED HANDLING/USE ERROR, LOADING ISSUES, FOLDING/UNFOLDING ISSUES, AND BROKEN HAPTIC. IT WAS NOTED WRONG CARTRIDGE USED. THE LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. HOWEVER, AN INCISION ENLARGEMENT WAS REQUIRED. THE PRODUCT WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 11033453 ↗
• InjuryJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS WAS EXPLANTED FROM PATIENT¿S RIGHT EYE (OD) IN A SECONDARY SURGICAL PROCEDURE AS THE PATIENT WAS UNABLE TO TOLERATE THE LENS. IT WAS INDICATED THAT THE GOAL WAS PLANO AND THEY GOT +4.0. A REPLACEMENT LENS OF THE SAME MODEL, BUT DIFFERENT DIOPTER (24.0) WAS USED. IT WAS NOTED THAT THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10306378 ↗
• InjuryFeb 28, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZA9003 INTRAOCULAR LENS (IOL) WHEN BEING INSERTED INTO THE EYE WAS REMOVED. IT WAS LEARNED HOWEVER, UPON FURTHER FOLLOW-UP THAT THE IOL WAS FOUND TO HAVE DISLOCATED DURING THE POST-OP EXAM. IT WAS CONFIRMED THAT HOW THE EVENT OCCURRED WAS THAT THE PATIENT WAS IMPLANTED THE LENS, WENT OUT OF OPERATING ROOM (OR) BUT HAD TO GO BACK INTO THE OR DURING THE SAME DAY, BECAUSE THE DOCTOR SAID THAT THE LENS DISLOCATED. PATIENT WENT BACK INTO THE OR FOR LENS REMOVAL. PATIENT POST-OP WAS UNEVENTFUL, NO INJURIES, NO ADVERSE EVENTS. NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 9770702 ↗
• InjuryAug 16, 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 PATIENT'S OPERATIVE EYE DUE TO UNEXPECTED POST-OP REFRACTION AND RESIDUAL ASTIGMATISM. THE REPLACEMENT LENS WAS A DIFFERENT MODEL AND HIGHER DIOPTER. THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Code Available

  MAUDE report 8900133 ↗