TECNIS IOL ZA9003 (REF ZA90030225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 05050474529069), received between Jan 4, 2017 and Sep 1, 2026 — classified as 24 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• InjurySep 1, 2026Device Dislodged or Dislocated

  It was reported that a fully implanted three-piece spherical monofocal intraocular lens (IOL) was found to be dislocated on the left eye. The patient symptoms was noted to have persisted for approximately 7.5 years. The issue was observed during a postoperative examination conducted during a site visit. The original lens was subsequently explanted during a secondary surgery and was replaced with a AR40e monofocal intraocular lens (IOL) with a +22.0D. No unplanned surgical interventions such as, incision enlargement, sutures, or vitrectomy were required. Directions for use was followed. The patient has fully recovered. The patient was fully recovered. No further information was provided.

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

  MAUDE report 50553966 ↗
• 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 3 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19378206 ↗
• 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 1 OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19378176 ↗
• InjurySep 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AFTER IT WAS IMPLANTED DUE TO UNSPECIFIED REASONS. IT WAS REPLACED WITH A DIB00, 20.5 DIOPTER IOL. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES PERFORMED. THE PATIENT FULLY RECOVERED POST-OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 17760750 ↗
• MalfunctionAug 22, 2023Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597585 ↗
• MalfunctionJul 19, 2023Contamination; Contamination

  IT WAS REPORTED THE NON-PRELOADED ZA9003 MODEL INTRAOCULAR LENS (IOL) WAS INSERTED AND DEBRIS WAS OBSERVED ON THE POSTERIOR ASPECT OF THE IOL. THE INCISION WAS ENLARGED TO REMOVE AND REPLACE THE IOL SINCE THE DEBRIS COULD NOT BE CLEARED AWAY; THE DETAILS OF THE REPLACEMENT LENS ARE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 17353779 ↗
• MalfunctionJul 13, 2023Scratched Material; Scratched Material

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17322131 ↗
• MalfunctionJul 13, 2023Scratched Material; Scratched Material

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17322122 ↗
• MalfunctionJun 26, 2023Break; Break

  IT WAS REPORTED THAT THE ZA9003 INTRAOCULAR LENS WAS INSERTED IN THE PATIENTS RIGHT EYE AND AFTER INSERTION IT WAS NOTED THAT THE HAPTIC WAS CRIMPED. LENS WAS REMOVED AND REPLACED WITH SAME MODEL AND DIOPTER DURING THE SAME PROCEDURE. LENS WAS CUT IN HALF AND REMOVED. PATIENT WAS DOING WELL AND FINE. ADDITIONAL INFORMATION RECEIVED REVEALED THAT THERE WERE NO OTHER ISSUES OR INJURIES OR INTERVENTIONS PERFORMED. IT IS UNKNOWN WHETHER THERE WAS ANY USE ERROR. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17200025 ↗
• InjuryMay 22, 2023Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS FULLY INSERTED IN THE PATIENT'S LEFT EYE, BUT HAD BENT/BROKEN HAPTIC, VITRECTOMY PERFORMED. THE SUSPECT IOL WAS REMOVED AND REPLACED WITH THE BACK-UP IOL OF THE SAME MODEL AND SAME DIOPTER SIZE. THE ISSUE DID NOT SIGNIFICANTLY AFFECT PATIENT¿S DAILY ACTIVITIES. PATIENT OUTCOME UNKNOWN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16981354 ↗
• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD CATARACT SURGERY AND IOL WAS IMPLANTED. POST IMPLANTATION PATIENT PRESENTED WITH REFRACTIVE SURPRISE IN THE RIGHT EYE. SYMPTOMS PERSISTED OVER A MONTH. THE IOL LENS WAS EXPLANTED AND REPLACED WITH DIB00 +21.0 D LENS. NO OTHER MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 16855503 ↗
• InjuryMay 4, 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 OPERATIVE EYE. THE PATIENT STATUS WAS REPORTED AS TEMPORARILY IMPAIRED AND DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. AN INCISION ENLARGEMENT AND VITRECTOMY WERE NOT REQUIRED. THROUGH FOLLOW-UP, THE CUSTOMER CONFIRMED NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 14272618 ↗
• InjuryMar 20, 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 INSERTED INTO PATIENT'S RIGHT EYE, HOWEVER, WAS REMOVED AS THE LENS FELL TO THE BACK OF THE EYE. VITRECTOMY WAS PERFORMED AND ANOTHER COMPETITOR LENS WAS USED AS THE REPLACEMENT. THERE WAS NO OTHER INJURY TO THE PATIENT AND THE PATIENT WAS DOING GOOD POST-OPERATION. THE ORIGINAL LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 13830270 ↗
• MalfunctionNov 4, 2021Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD HAPTIC BENT DURING LOADING. BUT IT WAS WAS NOTED UPON INSERTION. THERE WAS PATIENT CONTACT. THE LENS WAS NOT INSERTED. THE BACK-UP LENS WAS USED. IT WAS LEARNED THAT THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE THE PATIENT IS FINE POST-OP AND IT WAS UNKNOWN IF PRODUCT WILL BE RETURNED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12752577 ↗
• MalfunctionOct 26, 2021Scratched Material; Scratched Material

  THE ACCOUNT REPORTED THAT THE SURGEON IS SEEING SCRATCHES/STRIATIONS ALL OVER 4 TECNIS INTRAOCULAR LENSES (IOLS). HE¿S 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 MEDWATCH REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12699042 ↗
• MalfunctionOct 22, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE DOCTOR NOTED THE "STRIATIONS" (SCRATCHES) ALL OVER ON POSTERIOR SIDE OF THE LENS ONLY AFTER THE INTRAOCULAR LENS (IOL) HAS ALREADY BEEN IMPLANTED IN THE PATIENT. NO VISUAL ISSUES. PATIENT SO FAR IS OK. THE CUSTOMER WILL NOTIFY US IF THERE WILL BE INFORMATION OF VISUAL ISSUES LATER. EMERALDC CARTRIDGE USED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12683230 ↗
• InjuryAug 6, 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 FULLY INSERTED IN THE LEFT EYE AND REMOVED DURING THE SAME-PROCEDURE AS THE CAPSULE BROKE. ANOTHER JOHNSON & JOHNSON LENS (DIFFERENT MODEL DIU150 AND HIGHER DIOPTER 23.0) WAS IMPLANTED AS A REPLACEMENT. A VITRECTOMY WAS REQUIRED, HOWEVER, THERE WAS NO PATIENT INJURY. THE PATIENT IS DOING FINE POST-OPERATIVELY. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 12286031 ↗
• InjuryJun 17, 2021Material Discolored; Material Opacification; Material Discolored; Material Opacification

  IT WAS REPORTED THAT A PATIENT COMPLAINED OF FOGGY/BLURRY VISION IN THEIR LEFT EYE AND THAT THE IMPLANTED INTRAOCULAR LENS (IOL) WAS CLOUDY ON (B)(6) 2021 POST-OPERATION. THE DOCTOR COMMENTED THAT WHITENING/GLISTENING OF LENS MAY HAVE OCCURRED. NO LOSS OF VISION PROBLEM HAS BEEN OBSERVED AND THE VISUAL ACUITY (VA) WAS REPORTED TO BE 1.2. IT WAS INDICATED THAT THE LENS REMAINS IMPLANTED. THE VISUAL ACUITY (VA) BEFORE THE SURGERY WAS 1.0 AND THE TARGET REFRACTION OF SURGERY WAS EMMETROPIA. THE LENS WAS IMPLANTED AT ANOTHER CLINIC ON (B)(6) 2009 AND THERE WAS NO PROBLEM WHEN IT WAS INSPECTED AT THE CLINIC ON (B)(6) 2021. REPORTEDLY, THE DOCTOR WILL CONSIDER REPLACING THE LENS IF THE PATIENT'S EYESIGHT DETERIORATES, BUT AT THIS POINT THE DOCTOR WILL OBSERVE THE PROGRESS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 12014398 ↗
• MalfunctionJun 11, 2021Break; Break

  IT WAS REPORTED THAT AFTER THE CARTRIDGE TIP CONTACTED THE EYE, AN INTRAOCULAR LENS (IOL) WAS ADVANCED AND HAD A FRONT HAPTIC NOTED TO BE BENT. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A BACK-UP WITHOUT ANY COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11987309 ↗
• MalfunctionJun 9, 2021Break; Use of Device Problem; Inaccurate Delivery; Break; Use of Device Problem; Inaccurate Delivery

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD BEEN FOLDED UPSIDE DOWN DURING LOADING AND HAD BENT HAPTIC. THERE WAS PATIENT CONTACT WITH THE LENS. THE SURGEON ASKED FOR A NEW LENS AND ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971452 ↗
• InjuryMay 26, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS INSERTED INTO PATIENT'S RIGHT EYE, HOWEVER, THE DOCTOR DID NOT LIKE HOW THE LENS WAS SITTING IN THE EYE. THE LENS WAS REMOVED DURING THE SAME PROCEDURE, HOWEVER, NO REPLACEMENT LENS WAS PLACED. THERE WAS NO PATIENT INJURY AND NO MEDICAL INTERVENTIONS WERE REQUIRED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11882424 ↗
• MalfunctionFeb 24, 2021Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF THE INTRAOCULAR LENS (IOL) BROKE OFF AS IT LEFT THE CARTRIDGE. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS OF SAME MODEL. NO OTHER MEDICAL/ SURGICAL INTERVENTION WAS REQUIRED. THE EVENT WAS OBSERVED WHEN INSERTING INTO THE EYE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11371152 ↗
• InjuryJan 27, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AND INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO IOL SUBLUXED. IT WAS STATED THAT VITRECTOMY WAS ALSO DONE. SUSPECT IOL WAS REPLACED WITH THE SAME MODEL IOL BUT LOWER DIOPTER POWER (23.0). IT WAS NOTED THAT THERE WILL BE NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 11234999 ↗
• MalfunctionJan 11, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  RECEIVED REPORT INDICATING THERE WAS DEBRIS ON THE INTRAOCULAR LENS (IOL). THE IOL WAS FULLY INSERTED AND REMOVED AND REPLACED DURING THE SAME PROCEDURE. IT WAS INDICATED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11152935 ↗
• InjuryAug 4, 2020Break; Break

  IT WAS REPORTED THAT HAPTIC BENT DURING IMPLANTATION OF ZA9003 MODEL INTRAOCULAR LENS INTO THE PATIENT'S EYE. THE IOL WAS REMOVED AND REPLACED IN THE SAME PROCEDURE AND INCISION WAS ENLARGED TO REMOVE THE LENS FROM THE EYE. VITRECTOMY AND SUTURES WERE NOT REQUIRED. THERE WAS A DELAY OF THIRTY MINUTES IN THE PROCEDURE. THE PATIENT WAS DOING GOOD AT THE TIME OF DISCHARGE. THE REPORTED EVENT WAS OBSERVED WHILE INSERTING INTO THE EYE. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10363224 ↗