TECNIS IOL ZA9003 (REF ZA90030155)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 05050474528925), received between Feb 15, 2017 and Sep 14, 2026 — classified as 11 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Device Dislodged or Dislocated

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

  MAUDE report 50765500 ↗
• InjuryOct 29, 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 LEFT EYE BECAUSE IT HAD DISLOCATED. THE LENS WAS DISLOCATED APPROXIMATELY 4 MONTHS. THE EXPLANTED LENS WAS REPLACED WITH ANOTHER JNJ LENS, MODEL IS ZA9003 +16.0 DIOPTER. THERE WAS NO INCISION ENLARGEMENT, AND NO SUTURES USED. REPORTEDLY, THE DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 20563917 ↗
• MalfunctionJun 28, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19639628 ↗
• MalfunctionMay 10, 2024Break; Break

  IT WAS REPORTED THAT THERE WAS HAPTIC BENT DURING IMPLANTATION OF THE INTRAOCULAR LENS (IOL). THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19288970 ↗
• InjuryDec 29, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE AND REPLACED WITH AN ANTERIOR CHAMBER LENS DUE TO THE LENS BEING DISLOCATED, WHICH WAS DISCOVERED AT A FOLLOW-UP EXAM. A VITRECTOMY WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 18422466 ↗
• InjuryAug 31, 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 RIGHT EYE DUE TO REFRACTIVE SURPRISE. THE PATIENT WAS UNABLE TO ADAPT TO THE LENS. A NON-JOHNSON & JOHNSON LENS OF 15.0 DIOPTER WAS USED AS A REPLACEMENT. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 17666500 ↗
• MalfunctionNov 10, 2022Break; Break

  IT WAS REPORTED THAT UPON FULL INSERTION OF AN INTRAOCULAR LENS (IOL) INTO A PATIENT¿S LEFT EYE, THE TRAILING HAPTIC WAS NOTICED TO BE BROKEN. THE IOL WAS REMOVED AND REPLACED. THE LENS IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED BY THE ACCOUNT. ANOTHER LENS OF THE SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. THERE WERE NO SURGICAL AND/OR MEDICAL INTERVENTIONS REQUIRED. THE PATIENT IS DOING WELL POST-OP. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15767543 ↗
• InjuryApr 6, 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 THE PATIENT EXPERIENCING HYPEROPIC REFRACTIVE SURPRISE DYSPHOTOPSIAS, MIXED. THE DYSPHOTOPSIAS WERE REPORTED AS STARBURSTS AND GLARE. THE ISSUE WAS FIRST OBSERVED DURING A POST OPERATIVE EXAMINATION. THE EXPLANTED IOL WAS REPLACED WITH A NON-J&J LENS. THE INCISION WAS ENLARGED. THERE WAS NO VITRECTOMY OR SUTURES USED. MEDICATION WAS PRESCRIBED SUCH AS PRED, MOXIFLOXACIN AND NEVANAC. HOWEVER, THE HEALTH CARE PROFESSIONAL (HCP) EXPLAINED THAT IT'S PART OF THE STANDARD OF CARE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Flashers; Visual Disturbances; Visual Impairment

  MAUDE report 14027106 ↗
• 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 12684026 ↗
• InjuryAug 12, 2021Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A TECNIS INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT'S LEFT EYE BUT HAS TO BE REPLACED DUE THE IOL WOULD NOT UNFOLD. REPORTEDLY, THE PATIENT'S CAPSULE TORE DURING THE PROCEDURE. A BACK UP LENS OF THE SAME MODEL AND DIOPTER WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT OUTCOME WAS NOT PROVIDED. SUSPECT PRODUCT DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 12317053 ↗
• InjuryJul 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS NOT SATISFIED WITH THEIR VISUAL OUTCOME POST-IMPLANT OF AN INTRAOCULAR LENS (IOL) IN THE RIGHT EYE. THE IOL WAS SUBSEQUENTLY EXPLANTED APPROXIMATELY 13 MONTHS LATER AND REPLACED WITH COMPETITOR LENS OF A HIGHER DIOPTER (16.0). PATIENT OUTCOME POST-EXCHANGE WAS NOT PROVIDED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Discomfort

  MAUDE report 12200472 ↗
• InjuryJul 20, 2020Break; Break

  IT WAS REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT'S EYE, THE SURGEON NOTICED THAT THE HAPTIC WAS BROKEN. THE LENS WAS REMOVED AND REPLACED USING A BACK-UP IOL OF THE SAME MODEL AND DIOPTER. IT WAS STATED THAT THE INCISION WAS ENLARGED, REQUIRED ONE STITCH, AND A VITRECTOMY WAS PERFORMED. THERE WAS NO PATIENT POST-OP INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 10299095 ↗
• MalfunctionMar 4, 2019Break; Break

  IT WAS REPORTED THAT A ZA9003 DIOPTER 15.5 INTRAOCULAR LENS WAS OBSERVED DAMAGED WHEN REMOVING FROM PACKAGING. THERE WAS NO INDICATION OF PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8385077 ↗
• MalfunctionJan 23, 2019Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF A ZA9003 15.5 DIOPTER INTRAOCULAR LENS (IOL) HAPTIC WAS BROKEN WHEN INSERTING INTO THE PATIENT'S LEFT EYE (OS). THEREFORE, THE LENS WAS REMOVED AND REPLACED. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. REPORTEDLY, THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8269799 ↗
• InjurySep 10, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ZA9003 MONOFOCAL INTRAOCULAR LENS (IOL) HAD TO BE EXPLANTED FROM PATIENT'S RIGHT EYE (OD) DUE TO POSTERIOR DISLOCATION OF LENS. MOREOVER, THERE WAS ANTERIOR VITRECTOMY AND THERE WAS SUTURE REQUIRED. PRODUCT IS EXPECTED TO BE RETURNED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7862776 ↗
• InjuryApr 27, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZA9003 15.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE LENS DISLOCATED. THERE WAS NO INCISION ENLARGEMENT, AND THE PATIENT WAS REPORTED AS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7467701 ↗
• InjuryMar 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LENS EXCHANGE, THE PATIENT'S CAPSULE TORE WHILE IMPLANTING A ZA9003 15.5 DIOPTER INTRAOCULAR LENS (IOL). THIS LENS DROPPED INTO PATIENT'S EYE SINCE THEIR CAPSULE HAD RUPTURED. THE LENS HAD TO BE RETRIEVED BY A RETINA SPECIALIST. VITRECTOMY WAS REQUIRED AND THE LENS WAS REPLACED WITH A NON AMO DEVICE. THE PROCEDURE WAS SUCCESSFUL AND THE PATIENT IS DOING FINE.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 6389985 ↗
• MalfunctionFeb 15, 2017Difficult to Fold, Unfold or Collapse; Kinked; Difficult to Fold, Unfold or Collapse; Kinked

  ACCORDING TO THE SURGEON, THE INTRAOCULAR LENS (IOL) HAD A CREASE IN ITS CENTER WHEN IT UNFOLDED. THE SURGEON LOADED THE IOL AND BEGAN TO INSERT IT INTO THE EYE. AS THE LENS WAS UNFOLDING INSIDE THE EYE, HE COULD SEE THAT IT DIDN'T LOOK RIGHT UNDER THE MICROSCOPE. IT WAS STATED THAT THE IOL HAD A CREASE IN IT AND WAS NOT UNFOLDING CORRECTLY. THE IOL WAS REMOVED AND REPLACED WITH A DIFFERENT ONE DURING THE SAME PROCEDURE. THE INCISION DID NOT HAVE TO BE ENLARGED. THE PATIENT WAS NOT INJURED. THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6333267 ↗