TECNIS IOL ZA9003 (REF ZA90030195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 05050474529007), received between Aug 22, 2016 and Sep 15, 2026 — classified as 36 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Break” (23 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 66 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777871 ↗
• MalfunctionJun 24, 2025Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF THE NON PRELOADED INTRAOCULAR LENS (IOL) WAS BROKEN. THE ISSUE WAS NOTICED DURING IMPLANTATION/APPLICATION OF THE LENS. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN THE SAME PROCEDURE. THE PATIENT HAD FULLY RECOVERED AND THERE WERE NO VISUAL ISSUES OR IMPAIRMENT NOTED WITH THE PATIENT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22324970 ↗
• InjuryApr 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE. THE IOL DISLOCATED AND CAUSED VISUAL ISSUES. THE VISUAL ISSUES WERE NOT DESCRIBED BY THE CUSTOMER. THE EXPLANTED LENS WAS REPLACED WITH THE SAME MODEL AND DIOPTER, ZA9003 +19.5 DIOPTER. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 19056448 ↗
• MalfunctionDec 21, 2023Break; Break

  IT WAS REPORTED THAT THERE WAS LENS DAMAGE NOTED BEFORE IMPLANTATION OF NON PRELOADED MONOFOCAL LENS INTO THE PATIENT'S EYE. THE LENS WAS REPLACED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18376076 ↗
• MalfunctionSep 12, 2023Break; Break

  IT WAS REPORTED THAT TECNIS NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAPTIC WAS NOTED TO BE BENT AFTER INSERTION IN THE LEFT EYE. THE LENS WAS REMOVED. ADDITIONAL INFORMATION STATED THAT THE EMERALD CARTRIDGE WAS USED. THERE WAS NO PATIENT INJURY AND NO OTHER MEDICAL/SURGICAL INTERVENTIONS WERE REQUIRED. THE PATIENT IS DOING GOOD POST OP. THE PRODUCT WAS DISCARDED AND NOT BEING RETURNED. UPON FURTHER FOLLOW UP, IT WAS CONFIRMED THAT THE HAPTIC WAS ONLY BENT AND IT WAS NOT DETACHED. THE INNER POUCH WAS SEALED. THE LENS WAS REMOVED AND REPLACED IN THE SAME PROCEDURE WITH THE ANOTHER LENS OF SAME MODEL AND DIOPTER. THERE WAS NO USE ERROR THAT LED TO EVENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17732646 ↗
• InjuryAug 29, 2023Use of Device Problem; Ejection Problem; Use of Device Problem; Ejection Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED AND REMOVED DURING THE SAME PROCEDURE DUE TO A LOADING ERROR; THE DOCTOR DID NOT LIKE THE WAY IOL WAS IN THE CARTRIDGE. ANOTHER JOHNSON & JOHNSON LENS, MODEL ZA9003 19.5 DIOPTER WAS IMPLANTED INTO THE PATIENT'S OPERATIVE EYE. NO ADDITIONAL MANEUVERS WERE REQUIRED TO REMOVE THE LENS FROM THE INTRAOCULAR SPACE AND THERE WAS NO PATIENT INJURY. HOWEVER, AN UNPLANNED VITRECTOMY WAS PERFORMED. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. PATIENT OUTCOME POST-PROCEDURE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17646113 ↗
• MalfunctionAug 29, 2023Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT NON PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAPTIC WAS BROKEN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17644678 ↗
• InjuryJul 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ZA9003 INTRAOCULAR LENS WAS INSERTED IN THE PATIENTS RIGHT EYE. PATIENT RETURNED ON NEXT DAY AND LENS WAS REMOVED DUE TO MIGRATION INTO THE POSTERIOR CHAMBER AND VITRECTOMY WAS PERFORMED. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THERE WERE NO OTHER ISSUES WITH ZA9003 LENS. IT WAS AN UNPLANNED VITRECTOMY. OTHER PATIENT INJURIES, INTERVENTIONS AND OUTCOME WAS UNKNOWN. ZA9003 LENS IS NOT BEING RETURNED AS IT WAS SENT TO PATHOLOGY AS PER HOSPITAL PROTOCOL. NO OTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 17373275 ↗
• InjuryJul 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ZA9003 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S OCULAR SINISTER (LEFT EYE). IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED DUE TO COMPLAINTS OF POSITIVE DYSPHOTOPSIA AND THE ZA9003 IOL WAS REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION 19.0 DIOPTER IOL. THERE WAS NO INCISION ENLARGEMENT, NO PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY. PATIENT POST-LENS EXCHANGE OUTCOME WAS REPORTED AS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Flashers

  MAUDE report 17333696 ↗
• MalfunctionJun 25, 2023Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) IMPLANTED BUT HAD A BENT HAPTIC DUE TO LENS LOADING SO CUT IT OUT AND REPLACED WITH ANOTHER JOHNSON & JOHNSON LENS. THERE WERE NO VITRECTOMY, NO INCISION ENLARGEMENT OR SUTURES REQUIRED, AND NO SURGICAL/MEDICAL INTERVENTIONS WILL BE DONE IN THE FUTURE. THE ISSUE DID NOT INTERFERE WITH THE PATIENT¿S DAILY ACTIVITIES. THE PATIENT IS DOING FINE POST-OP AND NO INJURY REPORTED. THE DEVICE WILL NOT BE RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17196112 ↗
• InjuryApr 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ZA9003 INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO PATIENT¿S OCULAR DEXTER (RIGHT EYE). THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE DUE TO THE PATIENT WANTING NEAR TARGET OCULUS UTERQUE (OU - BOTH EYES) AND REPLACED WITH A ZA9003 21.5 DIOPTER IOL. THERE WAS NO INCISION ENLARGEMENT, NO SUTURE(S), NO VITRECTOMY, AND NO MEDICATION WAS PRESCRIBED. PRE-OPERATIVE VISION: DVA CC 20/25. POST-OPERATIVE VISION: DVA SC 20/25+1 NVA SCJ4. PATIENT STATUS POST-LENS EXCHANGE WAS REPORTED AS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16687021 ↗
• InjuryMar 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZA9003 INTRAOCULAR LENS IN THE LEFT EYE OF THE PATIENT HAS BEEN EXPLANTED IN THE SECONDARY PROCEDURE DUE TO POSITIVE DYSPHOTOPSIA WHICH WAS FIRST IDENTIFIED DURING POST OP EXAMINATION. THE SYMPTOMS PERSISTED FOR 5 MONTHS. NO MEDICATION WAS PRESCRIBED. NEITHER VITRECTOMY NOR INCISION ENLARGEMENT WAS REQUIRED. PATIENT HAS FULLY RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Flashers

  MAUDE report 16473193 ↗
• InjuryNov 17, 2022Adverse 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 THE PATIENT'S LEFT EYE DUE TO BEING "MISPOWERED". THE PROBLEM WAS NOT RELATED TO USER ERROR. A NON-JOHNSON AND JOHNSON IOL WAS IMPLANTED AS A REPLACEMENT (DIOPTER 19.0). NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 15821073 ↗
• MalfunctionJul 21, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAPTIC BENT UPON PLACING IN THE PATIENT'S OPERATIVE EYE AND THE LENS WAS REMOVED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15080791 ↗
• InjuryJul 7, 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 THE PATIENT'S LEFT EYE DUE TO MYOPIC OUTCOME. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THE PATIENT HAS FULLY RECOVERED. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE REPLACEMENT LENS INFORMATION IS NOT AVAILABLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 14948621 ↗
• InjuryMay 26, 2022Adverse 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/REMOVED FROM THE PATIENT'S OPERATIVE EYE. VITRECTOMY, INCISION ENLARGEMENT, AND SUTURE(S) WERE REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. REPLACEMENT LENS USED TO COMPLETE THE PROCEDURE WAS A DIFFERENT MODEL IOL. ACCOUNT PROVIDED THAT THE IOL WAS DISCARDED UPON RETRIEVAL. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 14506069 ↗
• InjuryMar 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ONE-PIECE INTRAOCULAR LENS (IOL) WAS INSERTED INTO PATIENT'S LEFT EYE, HOWEVER, IT WAS REMOVED DURING THE SAME PROCEDURE DUE TO CAPSULAR BREAK. ANOTHER J&J LENS, ZA9003 (DIFFERENT MODEL, LOWER DIOPTER) WAS ATTEMPTED TO BE USED AS THE REPLACEMENT, HOWEVER, THE IOL WAS ALSO REMOVED AS A VITRECTOMY WAS REQUIRED. THE PROCEDURE WAS COMPLETED USING ANOTHER J&J SECOND THREE-PIECE LENS. THE PATIENT WAS DOING GOOD POST-OPERATION. THE REMOVED LENSES WERE DISCARDED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES THE THREE-PIECE LENS WHICH WAS INSERTED AND REMOVED DURING THE SAME PROCEDURE AS VITRECTOMY WAS PERFORMED. A SEPARATE REPORT IS BEING SUBMITTED FOR THE ONE-PIECE LENS WHICH WAS INSERTED FIRST AND REMOVED DURING THE SAME PROCEDURE DUE TO CAPSULAR BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13835692 ↗
• MalfunctionDec 1, 2021Break; Break

  IT WAS REPORTED THAT A ZA9003 MODEL INTRAOCULAR LENS(IOL) HAD BENT/ BROKEN HAPTIC. THE LENS WAS REMOVED FROM PATIENT'S LEFT EYE. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS PLACED INTO PATIENT'S EYE. NO INCISION ENLARGEMENT WAS DONE. PATIENT HAS RECOVERED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12909811 ↗
• InjuryNov 24, 2021Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) HAD A DEFAULT. THROUGH FOLLOW-UP ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING REPORTED LENS DEFAULT AS SOME RESISTANCE WHEN PUSHING THE PLUNGER IN. THE IOL WAS FULLY INSERTED INTO THE PATIENT'S OCULAR SINISTER (LEFT EYE) AND REMOVED; PATIENT DID NOT HAVE AN IOL IMPLANTED AFTER THE PROCEDURE WAS COMPLETED. THERE WAS NO UNPLANNED INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, AND NO UNPLANNED VITRECTOMY HOWEVER, UNPLANNED SUTURE(S) WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12866969 ↗
• InjuryNov 16, 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 THE PATIENT'S RIGHT EYE DUE TO PATIENT EXPERIENCING VISUAL DISTURBANCE. THE PATIENT HAD VERY BOTHERSOME GLARE SYMPTOMS SUCH THAT THE PATIENT HAD TO WEAR A CAP OR SHIELD FOR HIS EYES TO FUNCTION UNDER OVERHEAD LIGHTING, ESPECIALLY AT NIGHT. THE PATIENT DIDN'T RESPOND TO TRIAL OF BRIMONIDINE, NOR RESPONDED TO CORRECTION OF REFRACTIVE ERROR OR TREATMENT OF OCULAR SURFACE. POST-OP BEST CORRECTED VISUAL ACUITY (BCVA) AFTER THE IMPLANTATION OF THE ORIGINAL LENS WAS 20/20. ANOTHER LENS OF DIFFERENT MODEL, BUT SAME DIOPTER WAS PLACED AS THE REPLACEMENT. THE PATIENT'S CONDITION HAS IMPROVED WITH LENS EXCHANGE. THERE WAS NO PATIENT INJURY REPORTED AND NO OTHER INTERVENTION WAS REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 12818353 ↗
• InjuryNov 9, 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 IMPLANTED INTO THE PATIENT¿S LEFT EYE. THE PATIENT EXPERIENCED BLURRY VISION AND HALOS. THE CUSTOMER CONSIDERS THE DELAY IN PROCEDURE APPROXIMATELY 10 MONTHS LATER WHEN THE EXPLANT TOOK PLACE. THE IOL WAS EXPLANTED AND REPLACED WITH A NON JOHNSON & JOHNSON LENS. THERE WAS NO INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo

  MAUDE report 12783968 ↗
• MalfunctionOct 26, 2021Scratched Material; Scratched Material

  THE ACCOUNT REPORTED THAT THE SURGEON IS SEEING SCRATCHES/STRIATIONS ALL OVER 4 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. NOTE: THIS COMPLAINT FOLDER CAPTURES SERIAL (B)(4). THE OTHER SERIAL NUMBERS ARE BEING CAPTURED IN SEPARATE REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12701527 ↗
• MalfunctionOct 22, 2021Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS REMOVED FROM PATIENT'S LEFT EYE AS A PIECE OF OPTIC EDGE, WHERE THE HAPTIC INSERTS, BROKE OFF. THE INCISION WAS ENLARGED AND ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT LENS. THE PATIENT WAS DOING OKAY POST OPERATION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12686282 ↗
• MalfunctionOct 1, 2021Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) CAME OUT OF THE CARTRIDGE LOOKING BENT. THE LENS WAS PARTIALLY INSERTED INTO PATIENT'S LEFT EYE BUT WAS REMOVED. SURGEON HAD SAME ISSUES WITH TWO LENS AND A THIRD LENS OF SAME WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY AND PATIENT WAS DOING FINE. NO FURTHER INFORMATION WAS AVAILABLE. THIS REPORT CAPTURES THE EVENT WITH THE SECOND LENS. A SEPARATE REPORT IS BEING SUBMITTED CAPTURING THE FIRST LENS WHICH HAD THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12566149 ↗
• MalfunctionOct 1, 2021Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) CAME OUT OF THE CARTRIDGE LOOKING BENT. THE LENS WAS PARTIALLY INSERTED INTO PATIENT'S LEFT EYE BUT WAS REMOVED. SURGEON HAD SAME ISSUES WITH TWO LENSES AND A THIRD LENS OF SAME MODEL AND DIOPTER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY AND PATIENT WAS DOING FINE. NO FURTHER INFORMATION WAS AVAILABLE. THIS REPORT CAPTURES THE EVENT WITH THE FIRST LENS. A SEPARATE REPORT IS BEING SUBMITTED CAPTURING THE SECOND LENS WHICH HAD THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12566132 ↗