TECNIS IOL ZA9003 (REF ZA90030185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 05050474528987), received between Oct 31, 2016 and Jun 17, 2025 — classified as 24 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2025Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT NON PRELOADED INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S EYE AND SUBSEQUENTLY EXPLANTED DUE TO A CRACK IN THE OPTIC OF THE LENS. THE SURGEON CONFIRMED THAT THE LENS WAS REMOVED WITHOUT ANY ISSUES, AND A DCB00 LENS WAS INSERTED WITHOUT INCIDENT. ALTHOUGH THE LENS DID TOUCH THE PATIENT, THERE WAS NO PATIENT HARM, AND THE DEFECTIVE LENS WAS DISCARDED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235367 ↗
• MalfunctionMay 22, 2024Break; Break

  IT WAS REPORTED THAT THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS DEFECTIVE. NO FURTHER INFORMATION WAS PROVIDED. THIS OCCURRED WITH THREE LENSES AND SEPARATE REPORTS ARE BEING SUBMITTED. THIS IS REPORT 2 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19378196 ↗
• MalfunctionDec 13, 2023Break; Break

  IT WAS REPORTED THAT INTRAOCULAR LENS HAD BENT HAPTIC. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18322897 ↗
• InjuryNov 30, 2023Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  A DOCTOR REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WOULD NOT LAY FLAT. THE LENS HAD PATIENT CONTACT. IT WAS INDICATED THAT VITRECTOMY AND INCISION ENLARGEMENT WERE REQUIRED, AND SUTURES USED. THE PROCEDURE WAS COMPLETED USING THE SAME LENS MODEL. THE PATIENT IS DOING FINE. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 18242297 ↗
• InjuryJul 20, 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 LEFT EYE DUE TO DYSPHOTOPSIA. IT WAS INDICATED THAT THE PATIENT'S SYMPTOMS PERSISTED FOR 7 MONTHS. A NON- JOHNSON AND JOHNSON IOL OF 18.0 DIOPTER WAS USED AS A REPLACEMENT. NO OTHER MEDICAL OR SURGICAL INTERVENTIONS DONE. IT WAS NOTED THAT THE PATIENT FULLY RECOVERED. NO OTHER PERTINENT INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 17358655 ↗
• InjuryApr 21, 2023Break; Difficult to Insert; Break; Difficult to Insert

  IT WAS REPORTED THAT ZA9003 INTRAOCULAR LENS WAS PLACED IN THE PATIENTS RIGHT EYE AND THEN REMOVED AS IT WOULD NOT SEAT CORRECTLY DUE TO UNSTABLE CHAMBER. LENS REMOVED AND REPLACED WITH OTHER ZA9003 LENS OF SAME DIOPTER. VITRECTOMY WAS PERFORMED. UPON FURTHER FOLLOW UP, IT WAS CONFIRMED THAT THE ZA9003 LENS WAS REMOVED AND REPLACED DURING SAME PROCEDURE. THE VITRECTOMY WAS UNPLANNED AND THE REASON FOR PERFORMING VITRECTOMY WAS THAT THE PATIENT HAD A POSTERIOR CAPSULAR TEAR THAT WAS NOTED AT THE TIME OF CORTICAL REMOVAL. THE DOCTOR REMOVED THE REST OF THE CORTEX AND PLANNED TO PUT IN A ZA9003 LENS IN THE CILIARY SULCUS. AS THE LENS WAS BEING INJECTED, HE NOTICED THAT THE LEADING HAPTIC WAS KINKED. THE KINKED LEADING HAPTIC WENT THROUGH THE TEAR IN THE POSTERIOR CAPSULE AND HE CUT OUT THE LENS DUE TO THE KINKED HAPTIC. THE DOCTOR WAS CONCERNED THAT THERE MIGHT HAVE BEEN SOME VITREOUS PROLAPSE FROM THE HAPTIC GOING THROUGH THE TEAR IN THE POSTERIOR CAPSULE, SO HE PERFORMED A LIMITED ANTERIOR VITRECTOMY BEFORE PLACING ANOTHER ZA9003 IN THE CILIARY SULCUS. DOCTOR ENLARGED 2.4MM INCISION TO ALLOW THE INJECTION OF THE ZA9003 LENS. HE PLACED SUTURES IN THE MAIN WOUNDS AND THE PARACENTESIS

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear; Vitreous Loss; Wound Dehiscence

  MAUDE report 16782596 ↗
• InjuryDec 15, 2022Adverse 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 A PATIENT'S RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE DUE TO PRESBYOPIA. THE PATIENT WAS REPORTED TO BE TEMPORARILY IMPAIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort; Visual Impairment

  MAUDE report 15993033 ↗
• MalfunctionApr 6, 2022Break; Break

  IT WAS REPORTED THAT INTRAOCULAR LENS (IOL) HAD DAMAGED HAPTIC. THERE WAS A PATIENT CONTACT. LENS WAS FULLY INSERTED AND REMOVED DURING THE SAME PROCEDURE. THE EVENT WAS OBSERVED WHEN INSERTED INTO THE EYE. THERE WAS NO PATIENT INJURY AND NO INTERVENTION FOUND. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14025671 ↗
• 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 SECOND LENS IN USE FOR THIS CASE. A SEPARATE REPORT IS BEING SUBMITTED FOR THE FIRST LENS INVOLVED.

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

  MAUDE report 13518896 ↗
• MalfunctionJan 27, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD AMPUTATED HAPTIC. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13377172 ↗
• MalfunctionJan 26, 2022Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD AN AMPUTATED HAPTIC. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13362140 ↗
• MalfunctionOct 26, 2021Scratched Material; Scratched Material

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12701462 ↗
• InjuryOct 19, 2021Failure to Fold; Material Fragmentation; Failure to Fold; Material Fragmentation

  IT WAS REPORTED THAT THE TECNIS INTRAOCULAR LENS (IOL) WAS FULLY INSERTED AND WAS REMOVED DUE TO FOLDING ISSUE AND A MISSING HAPTIC. THE PROCEDURE WAS COMPLETED WITH A BACK UP LENS. A VITRECTOMY WAS PERFORMED DURING THE PROCEDURE. NO INJURY WAS REPORTED. THE PATIENT OUTCOME WAS REPORTED AS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12661638 ↗
• InjuryJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE DUE TO POSITIVE DYSPHOTOPSIA. THE INCISION WAS ENLARGED AND THE LENS WAS REPLACED WITH A COMPETITOR LENS. THE EVENT WAS OBSERVED DURING POST-OPERATIVE EXAMINATION. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Flashers

  MAUDE report 12232778 ↗
• InjuryApr 7, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A ZA9003 MODEL INTRAOCULAR LENS(IOL) WAS EXPLANTED FROM PATIENT'S OPERATIVE EYE AS THE INTRAOCULAR LENS (IOL) GOT DISLOCATED. INCISION WAS ENLARGED AND SUTURED. THERE WAS NO PATIENT INJURY. THE REPLACEMENT LENS USED IS A NON JOHNSON AND JOHNSON VISION LENS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11632113 ↗
• MalfunctionMar 17, 2021Break; Break

  IT WAS REPORTED THAT A TECNIS INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED WITH A BACKUP LENS DURING THE SAME PROCEDURE BECAUSE OF HAPTIC DAMAGE. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION REQUIRED. IT WAS NOTED THE PATIENT HAS RECOVERED AND THE DAMAGED LENS WAS DISCARDED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11500000 ↗
• MalfunctionFeb 4, 2021Break; Break

  IT WAS REPORTED THAT WHEN THE DOCTOR INSERTED THE LENS INTO THE EYE OF THE PATIENT, HE SAW THAT THE HAPTIC WAS BROKEN. THE LENS WAS CUT AND REMOVED. THERE WAS NO PATIENT INJURY AND THE MATERIAL WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 11283347 ↗
• MalfunctionFeb 2, 2021Break; Break

  IT WAS REPORTED THAT A ZA9003 LENS WAS NOTED WITH BENT HAPTIC ISSUES. UNSURE IF THEY WERE BENT UPON OPENING OR AFTER BEING LOADED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11270098 ↗
• InjuryDec 21, 2020Adverse 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 EXPLANTED LENS WAS REPLACED WITH ANOTHER LENS, SAME MODEL, BUT HIGHER DIOPTER 21.5. NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 11052838 ↗
• InjuryDec 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZA9003 INTRAOCULAR LENS(IOL) WAS EXPLANTED FROM PATIENT''S RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE DUE TO PATIENT DISCOMFORT AND TOO MUCH MONOVISION. NO MEDICAL/SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, SUTURES OR INCISION ENLARGEMENT WERE PERFORMED. THE REPLACEMENT LENS USED IS A SAME MODEL BUT HIGHER DIOPTER 20.0. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Discomfort; No Code Available

  MAUDE report 10989478 ↗
• InjuryNov 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LENS WAS EXPLANTED. AFTER SEVERAL FOLLOW-UP ATTEMPTS NO FURTHER DETAILS COULD BE OBTAINED.

  Patient problems: No Code Available

  MAUDE report 10893449 ↗
• InjuryJul 7, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT LENS WAS INSERTED AND REMOVED IN SAME SURGICAL PROCEDURE BECAUSE THE SURGEON COULD NOT CENTER THE LENS. REPORTEDLY VITRECTOMY AND SUTURES WERE REQUIRED DURING THIS PROCEDURE. NO LENS WAS IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT PATIENT WAS LEFT APHAKIC AND PLANS ARE TO REFER THE PATIENT OUT. NO OTHER ISSUES WITH LENS. THE PROCEDURE LASTED FOR ONE HOUR AND NINE MINUTES AND A MALUYGIN RING WAS USED. PATIENT IS DOING BETTER, AND PATIENT¿S CLOUDING IS IMPROVING. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Corneal Edema; No Code Available; Vitrectomy

  MAUDE report 10242205 ↗
• InjuryApr 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A MODEL ZA9003 18.5 DIOPTER INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED IN THE PATIENT¿S OPERATIVE EYE AND VITRECTOMY WAS REQUIRED. IT WAS REPORTED THERE WAS NO PATIENT INJURY, THE PROCEDURE WAS COMPLETED USING BACK-UP LENS WITH THE SAME MODEL AND DIOPTER SIZE, AND PATIENT OUTCOME WAS REPORTED AS FINE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Vitrectomy

  MAUDE report 9942042 ↗
• InjuryFeb 3, 2020Product Quality Problem; Product Quality Problem

  IT WAS REPORTED ZA9003 18.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) WITH A DEFECT ON THE OPTIC. ON (B)(6) 2020, THROUGH FOLLOW UP, CUSTOMER ACCOUNT PROVIDED ADDITIONAL INFORMATION CLARIFYING REPORTED LENS DEFECT APPEARED TO LOOK LIKE A SCRATCH CENTER OF OPTIC, BUT WITHIN THE OPTIC NOT ON THE OUTSIDE. THE LENS WAS REMOVED WITHOUT INCISION ENLARGEMENT, AND NO VITRECTOMY, HOWEVER ONE (01) UNPLANNED 10-0 NYLON SUTURE WAS USED. THERE WAS NO SERIOUS PATIENT INJURY, NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 9663094 ↗
• InjuryDec 13, 2019Material Discolored; Material Opacification; Material Discolored; Material Opacification

  IT WAS REPORTED THAT DURING THE POSTOPERATIVE EXAMINATION, ON THE (B)(6) 2019 A CLOUDY LENS, MODEL TECNIS ZA9003, IMPLANTED ON THE (B)(6) 2019 WAS EXPLANTED. IT WAS IMPLANTED A NEW ZA9003 LENS AND THE RESULT WAS GOOD. NO VITRECTOMY WAS PERFORMED.

  Patient problems: No Code Available

  MAUDE report 9466941 ↗