TECNIS IOL ZA9003 (REF ZA90030150)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 05050474528918), received between Dec 14, 2016 and Aug 22, 2025 — classified as 10 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE CUSTOMER THAT A LENS WAS EXPLANTED DUE TO SUBLUXATION. IT WAS REMOVED AND REPLACED DURING A SECONDARY SURGICAL PROCEDURE WITH ANOTHER JOHNSON & JOHNSON MONOFOCAL INTRAOCULAR LENS (IOL). NO UNPLANNED INCISION ENLARGEMENT OR VITRECTOMY WAS REPORTED, AND THERE WAS NO DELAY IN THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 22874887 ↗
• InjuryDec 30, 2024Break; Break

  IT WAS REPORTED THAT THE NON PRELOADED INTRAOCULAR LENS (IOL) HAD HAPTIC ISSUE WHEN INSERTING THE LENS IN TO THE PATIENT'S LEFT EYE. THERE WERE SUTURES AND VITRECTOMY PERFORMED. THE PATIENT IS DOING FINE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21043725 ↗
• InjuryJun 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE NON PRELOADED MONOFOCAL INTRAOCULAR LENS(IOL) WAS FULLY INSERTED, HOWEVER AFTER IMPLANTATION OR APPLICATION, THE LENS WAS DISLOCATED. IT WAS REPLACED WITH ANOTHER ZA900 LENS WITH A DIFFERENT DIOPTER IOL. A SCLERAL-FIXED LENS WAS IMPLANTED. THE PATIENT'S STATUS IS UNKNOWN. IT IS UNKNOWN IF INJURY AND MEDICAL INTERVENTION WAS REQUIRED. THE PRODUCT IS AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 19506976 ↗
• MalfunctionMar 21, 2024Break; Break

  IT WAS REPORTED THAT THE HAPTIC BENT ON THE JOHNSON AND JOHNSON(JNJ) INTRAOCULAR LENS (IOL). AS THEY WERE PLACING THE LENS IN THE LEFT EYE THE HAPTIC BENT. THE IOL WAS CUT IN HALF AND REMOVED. THE LENS WAS REPLACED WITH THE SAME MODEL BUT 15.5 DIOPTER. THERE WERE NO OTHER COMPLICATIONS SUCH AS CAPSULE TEAR, VITRECTOMY, OR SUTURES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18955813 ↗
• MalfunctionAug 2, 2023Break; Ejection Problem; Break; Ejection Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THE IOL WAS PARTIALLY DELIVERED INTO THE PATIENT'S LEFT EYE AND THEN REMOVED. THE INCISION WAS ENLARGED. A VITRECTOMY AND SUTURE WERE NOT REQUIRED. THE IOL WAS REMOVED AND SUCCESSFULLY REPLACED WITH A BACK UP LENS DURING THE SAME PROCEDURE. NO OTHER INTERVENTION WERE REQUIRED. THE PATIENT WAS FINE WHEN DISCHARGED. THERE WERE NO ISSUES. THE IOL IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 17446705 ↗
• MalfunctionAug 1, 2023Break; Ejection Problem; Break; Ejection Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THE IOL WAS PARTIALLY DELIVERED INTO THE PATIENT'S LEFT EYE AND THEN REMOVED. THE INCISION WAS ENLARGED. A VITRECTOMY AND SUTURE WERE NOT REQUIRED. THE IOL WAS REMOVED AND SUCCESSFULLY REPLACED WITH ANOTHER JOHNSON & JOHNSON LENS, MODEL ZA9003 15.5 DIOPTER DURING THE SAME PROCEDURE. NO OTHER INTERVENTION WERE REQUIRED. THE PATIENT WAS FINE WHEN DISCHARGED. THERE WERE NO ISSUES. THE IOL IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 17439371 ↗
• InjuryMar 2, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  RECEIVED REPORT OF AN EXPLANT OF AN IOL (INTRAOCULAR LENS) THAT HAD BEEN IMPLANTED 13 YEARS AGO. THE IOL WAS DISPLACED IN THE EYE. IT¿S UNKNOWN IF THE ISSUE WAS AFFECTING THE PATIENT¿S DAILY ACTIVITIES. THE IOL WAS EXPLANTED. AN UNPLANNED VITRECTOMY OCCURRED. NO SUTURES WERE USED.THE REPLACEMENT LENS IS THE SAME MODEL BUT DIFFERENT DIOPTER, ZA9003 +13.5 DIOPTER. REPORTEDLY, THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 16473126 ↗
• InjuryNov 14, 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 RIGHT EYE DUE TO DYSPHOTOPSIA. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. A NON-JOHNSON & JOHNSON LENS WAS IMPLANTED AS A REPLACEMENT. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 15795068 ↗
• InjuryMay 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AFTER THE INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT'S OCULAR SINISTER (LEFT EYE) THE DOCTOR DID NOT THINK IT WOULD HOLD. THE IOL WAS REMOVED AND NO LENS WAS IMPLANTED. THE INCISION WAS ENLARGED AND SUTURE(S) WERE REQUIRED. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THE PATIENT DID HAVE PRIOR EYE HISTORY THAT CONTRIBUTED TO THE EVENT, 2X RETINAL SURGERY PRIOR TO IOL IMPLANT. THERE WAS NO PRODUCT QUALITY ISSUE THAT CONTRIBUTED TO THE EVENT. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS FINE. THE PATIENT HAS SURGERY SCHEDULED WITH A RETINA SURGEON. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 14342735 ↗
• InjuryOct 28, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT WHEN THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO ANTERIOR CHAMBER OF PATIENT'S RIGHT EYE, BUT BEFORE INSIDE THE CAPSULAR BAG, IT WAS NOTED THAT THE LEAD HAPTIC CRIMPED AND STUCK TO THE OPTIC OF THE LENS. THE CAPSULAR BAG WAS RENTED. THE INCISION WAS ENLARGED AND THE LENS WAS REMOVED AND A REPLACEMENT LENS OF SAME MODEL AND DIOPTER WAS FIXED TO THE SULCUS. SUTURE WAS PLACED. THE PATIENT WAS DOING FINE POST OPERATION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 12716036 ↗
• InjuryMay 5, 2021Break; Break

  A PATIENT REPORTED HAVING UNDERGONE CATARACT SURGERY IN THE LEFT EYE IN (B)(6) 2020. AFTER THE LENS WAS INSERTED INTO THE EYE AND UNFOLDED, THE DOCTOR NOTICED THAT THE TRAILING HAPTIC WAS BROKEN. IT WAS INDICATED THAT THE TRAILING HAPTIC PIERCED THE CAPSULE; THEREFORE, THE INCISION WAS ENLARGED AND THE LENS WAS REMOVED FROM THE EYE ON THE SAME DAY. A REPLACEMENT LENS FROM A DIFFERENT COMPANY WAS IMPLANTED AND A SUTURE WAS USED. THE PATIENT HAD SOME EDEMA/SWELLING. ON THE NEXT DAY POST-OPERATIONAL VISIT, THE COMPETITOR¿S LENS HAD DISLOCATED AND AT THAT POINT, THE PATIENT WAS REFERRED TO A RETINA SPECIALIST WHO PERFORMED A VITRECTOMY ON THE EYE. THE PATIENT COMPLAINED OF FLOATERS IN HER EYE WITH HER CURRENT COMPETITOR¿S IMPLANT AND INDICATED THAT SHE HAS HAD SEVERAL SURGERIES SINCE HER CATARACT SURGERY. THE PATIENT REPORTED HAVING UNDERGONE A CORNEA TRANSPLANT AND REPORTEDLY NOW MAY HAVE GLAUCOMA. THE PATIENT DOES NOT SEE WELL OUT OF LEFT EYE AND HER VISION IS BETTER IN THE MORNING, BUT TERRIBLE IN THE EVENINGS. THE PATIENT IS ABLE TO PERFORM HER DAILY TASKS; HOWEVER, SHE STILL HAS PAIN IN HER EYE WITH THE CURRENT IMPLANT. THE PATIENT HAS A JOHNSON AND JOHNSON LENS IN HER RIGHT EYE W

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear; Corneal Edema; Distress; Eye Infections; Eye Pain; Glaucoma; Intraocular Pressure Increased; Visual Disturbances; Visual Impairment; Vitreous Floaters; Vitreous Loss

  MAUDE report 11780848 ↗
• InjuryMay 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT (OS) EYE IN A SECONDARY PROCEDURE DUE TO HAVING DYSPHOTOPSIA. THE INCISION WAS ENLARGED, BUT NO HARM OR INJURY TO THE PATIENT. THE REPLACEMENT LENS IS AN EYEKON S102, 14.5 DIOPTERS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 11779666 ↗
• MalfunctionMar 17, 2021Break; Break

  IT WAS REPORTED THAT THE TECNIS INTRAOCULAR LENS (IOL) HAPTIC WAS BENT, AND THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11506649 ↗
• InjuryDec 10, 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 LEFT EYE IN A SECONDARY SURGICAL PROCEDURE BECAUSE OF REFRACTIVE SURPRISE. NO MEDICAL/SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, SUTURES OR INCISION ENLARGEMENT WERE PERFORMED. THE REPLACEMENT LENS USED IS A SAME MODEL BUT HIGHER DIOPTER 18.0. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10984598 ↗
• MalfunctionJan 14, 2019Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT INTRAOCULAR LENS HAD TORN OR BROKEN HAPTIC. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8246766 ↗
• MalfunctionDec 14, 2016Break; Break

  A BROKEN HAPTIC WAS REPORTED. THERE WAS PATIENT CONTACT. THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED. THERE WAS NO INCISION ENLARGEMENT. AN ANTERIOR VITRECTOMY WAS PERFORMED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACK-UP LENS. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: Vitrectomy

  MAUDE report 6172809 ↗