TECNIS IOL ZA9003 (REF ZA90030220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 05050474529052), received between Oct 5, 2016 and Sep 27, 2024 — classified as 1 death, 39 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Break” (45 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 82 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AFTER THE SURGEON IMPLANTED THE INTRAOCULAR LENS (IOL) INTO THE EYE, HE FOUND THAT THE HAPTIC OF THE IOL SEPARATED FROM THE OPTICAL SURFACE OF THE LENS ON ITS OWN. REPORTEDLY, IMMEDIATELY AFTER THE OCCURRENCE, THE IOL WAS REMOVED AND REPLACED WITH A NEW LENS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20323060 ↗
• InjuryNov 10, 2023Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) HAPTICS KINKED IN THE EYE. THE KINKED HAPTICS WERE NOTICED ONCE THE LENS WAS IN THE PATIENT¿S RIGHT EYE. THE DOCTOR EXPLAINED THAT THE HAPTICS KINKED BECAUSE THE TECHNICIAN LOADED IT INCORRECTLY. THE LENS LOOKED OK PRIOR TO LOADING IT. THE CAPSULE TORE AND AN UNPLANNED VITRECTOMY WAS PERFORMED. THE LENS WAS REMOVED AND ANOTHER IOL OF THE SAME MODEL AND DIOPTER WAS IMPLANTED IN THE SULCUS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 18112770 ↗
• MalfunctionAug 24, 2023Break; Break

  IT WAS REPORTED THAT THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAPTIC WAS BENT SO UNABLE TO USE. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17618359 ↗
• MalfunctionAug 24, 2023Break; Break

  IT WAS REPORTED THAT THE NON PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAPTIC WAS BENT, SO UNABLE TO USE. THERE WAS NO PATIENT INJURY AND MEDICAL/SURGICAL INTERVENTION REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17618312 ↗
• MalfunctionAug 14, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE SURGEON PERFORMED PARS PLANA VITRECTOMY PLUS PHACOFRAGMENTATION PLUS SUTURELESS SCLERAL FIXATION OF THE INTRAOCULAR LENS (IOL). DURING POST-OPERATIVE EXAMINATION BY SLIP-LAMP, IT WAS FOUND THAT THERE WAS A SCRATCH IN THE ANTERIOR SURFACE OF THE IOL WHEREAS THE LENS WAS POSITIONED AS DESIRED WITHOUT MIGRATION. THE PATIENT DID NOT HAVE ANY SYMPTOMS OR COMPLIANT WITH 0.8 INDICATED AS POST-OPERATIVE VISUAL ACUITY (VA). PATIENT IS BEING MONITORED, NEXT VISIT IS IN A MONTH. ADDITIONAL INFORMATION RECEIVED PROVIDED THAT THE CARTRIDGE USED WAS EMERALD30 AND THE PHACOEMULSIFICATION SYSTEM USED WAS A NON-JOHNSON AND JOHNSON DEVICE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17547212 ↗
• MalfunctionAug 13, 2023Scratched Material; Scratched Material

  IT WAS REPORTED AFTER THE ZA9003 MODEL INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE), A SCRATCH WAS NOTICED. THE IOL WAS REMOVED AND REPLACED WITH ANOTHER ZA9003 22.0 DIOPTER IOL DURING THE SAME PROCEDURE. THERE WAS NO DELAY IN PROCEDURE, NO INCISION ENLARGEMENT, NO SUTURE(S), AND NO VITRECTOMY. PATIENT OUTCOME POST-PROCEDURE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17538192 ↗
• MalfunctionJul 28, 2023Break; Material Fragmentation; Appropriate Device Problem Term/Code Not Available; Break; Material Fragmentation; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED, THAT AN INTRAOCULAR LENS (IOL) HAD A BROKEN HAPTIC. AND THE LENS WAS CUT OUT. THERE WAS PATIENT CONTACT WITH THE PRODUCT. THROUGH FOLLOW UP, IT WAS LEARNED, THAT WHEN THE SURGEON PUT IN A LENS, THE DEFECTIVE HAPTIC BROKE OFF INSIDE THE EYE. SURGEON CUT OUT THE LENS AND TRIED TO PUT IN A SECONDARY LENS. HOWEVER, THE LENS NEVER CAME OUT OF THE LOADER. THEREFORE, A THIRD LENS WAS PUT IN. SURGEON INDICATED, IT WAS NOT THE BEST EXPERIENCE OVERALL. THE LENS HAS BEEN DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17419041 ↗
• MalfunctionJul 4, 2023Break; Break

  IT WAS REPORTED THAT A PARTIALLY INSERTED INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE DUE TO BENT/BROKEN HAPTIC. THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17253379 ↗
• InjuryJun 6, 2023Inaccurate Delivery; Ejection Problem; Inaccurate Delivery; Ejection Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) BACKED OUT OF THE WOMB. THE ISSUE WAS NOTICED WHEN THE LENS WAS BEING PARTIALLY INSERTED INTO THE PATIENT¿S RIGHT EYE. THERE WAS AN INCISION ENLARGEMENT AND A VITRECTOMY PERFORMED. THE PATIENT DID NOT GET A LENS ON THIS SURGERY DAY. THE PATIENT IS RECOVERING WELL. NO FURTHER INFORMATION WAS PROVIDED. THE CUSTOMER REPORTED TWO INCIDENTS WITH THE SAME EYE OF THE PATIENT; HOWEVER, IT IS UNKNOWN WHICH LENS WAS ATTEMPTED FIRST. THIS EMDR REPORT IS TWO (2) OUT OF TWO (2). A SEPARATE REPORT WILL BE SUBMITTED FOR THE OTHER INCIDENT.

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

  MAUDE report 17076118 ↗
• InjuryJun 6, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) FULLY INSERTED INTO A PATIENT'S RIGHT EYE AND HAPTIC CAME OFF, FULLY DETACHED. THE HAPTIC ISSUE WAS OBSERVED AFTER INSERTION OF THE LENS INTO THE EYE. THERE WAS AN INCISION ENLARGEMENT AND A VITRECTOMY PERFORMED. THE PATIENT IS RECOVERING WELL, AND THE ISSUE DID NOT SIGNIFICANTLY INTERFERE WITH THE PATIENT¿S DAILY ACTIVITIES. NO FURTHER INFORMATION WAS PROVIDED. THE CUSTOMER REPORTED TWO INCIDENTS WITH THE SAME EYE OF THE PATIENT; HOWEVER, IT IS UNKNOWN WHICH LENS WAS ATTEMPTED FIRST. THIS EMDR REPORT IS ONE (1) OUT OF TWO (2). A SEPERATE REPORT WILL BE SUBMITTED FOR THE OTHER INCIDENT.

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

  MAUDE report 17076080 ↗
• MalfunctionMay 23, 2023Break; Break

  IT WAS REPORTED THE ZA9003 MODEL INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THE IOL WAS REMOVED DURING THE SAME PROCEDURE DUE TO CRAMPED HAPTIC. ONE NURSE SAID, HAPTIC WAS BENT AND ANOTHER NURSE SAID IT WAS DETACHED, BUT NOT FULLY DETACHED. AS DOCTOR DID NOT INDICATE THAT HE NEEDED TO LOOK FOR THE HAPTIC, THE REPORTER THINKS THE HAPTIC WAS BENT. THE REPLACEMENT IOL WAS ANOTHER ZA9003 22.0 DIOPTER IOL. THERE WAS NO PATIENT ISSUES AND THERE IS NO INDICATION OF MEDICAL AND/OR SURGICAL INTERVENTION. PATIENT STATUS POST-PROCEDURE WAS REPORTED AS FINE. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16987356 ↗
• MalfunctionMay 1, 2023Break; Break

  IT WAS REPORTED THAT THE TRAILING HAPTIC OF THE INTRAOCULAR LENS (IOL) WAS NOTICED TO BE BENT AFTER BEING IMPLANTED INTO THE PATIENT'S EYE. THE IOL WAS REMOVED AND REPLACED WITH A BACK UP IOL OF AN UNKNOWN MODEL AND SERIAL NUMBER. THERE WAS NO REPORTED PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16845079 ↗
• InjuryApr 25, 2023Break; Break

  IT WAS REPORTED THAT WHEN THE PATIENT CAME IN, SHE HAD NO NATURAL LENS OR INTRAOCULAR LENS IN THE RIGHT EYE (OD). AN INTRAOCULAR LENS (IOL) HAPTIC TWISTED DURING INSERTION IN THE PATIENT'S RIGHT EYE. DOCTOR WAS GOING TO CUT THE LENS OUT OF THE EYE, BUT SCISSORS BROKE IN THE EYE DURING THE ATTEMPT. ENTIRE LENS AND SCISSOR PARTS WERE REMOVED FROM THE EYE, BUT ARE NOT AVAILABLE TO BE SENT FOR EVALUATION. THERE WAS INCISION ENLARGEMENT AND SUTURES USED. ANOTHER JOHNSON AND JOHNSON IOL WITH THE SAME MODEL AND DIOPTER WAS IMPLANTED. THE PATIENT SEEMS FINE POST-OP. THE CARTRIDGE IS NOT AVAILABLE FOR RETURN. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 16804622 ↗
• MalfunctionMar 9, 2023Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) PARTIALLY INSERTED INTO A PATIENT¿S RIGHT EYE AND REMOVED DUE TO BENT HAPTIC. THE ISSUE WAS NOTICED WHILE INSERTING THE LENS. A BACK UP LENS WITH THE SAME MODEL AND DIOPTER WAS USED AS A REPLACEMENT IOL TO COMPLETE THE SURGERY. IT WAS INDICATED THAT THE LENS WAS NOT STUCK IN THE CARTRIDGE. THERE WERE NO SURGICAL AND/OR MEDICAL INTERVENTIONS REPORTED. THE PATIENT IS DOING FINE POST-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16519361 ↗
• InjuryFeb 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE IOL WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE DUE TO DYSPHOTOPSIA. FIRST IDENTIFIED DURING A POST-OPERATIVE EXAM. THERE WERE NO COMPLICATIONS SUCH AS A VITRECTOMY, SUTURES OR INCISION ENLARGEMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NON JNJ LENS. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 16287877 ↗
• MalfunctionJan 4, 2023Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD A BENT BACK HAPTIC. THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16098412 ↗
• MalfunctionNov 4, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED INTO THE PATIENT'S LEFT EYE; HOWEVER, IT WAS REMOVED AS THE HAPTIC WAS BENT. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT IOL. THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTION WAS REQUIRED. THE PATIENT WAS DOING FINE POST-OPERATION. THE ORIGINAL LENS WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15731179 ↗
• MalfunctionSep 20, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE HAPTIC BROKE OFF. THROUGH FOLLOW UP WE LEARNED THAT AFTER IMPLANTATION OF THE INTRAOCULAR LENS (IOL), THE HAPTICS DETACHED FROM THE OPTIC. AS A RESULT, THE IOL WAS CUT WITH SCISSORS AND REMOVED FROM THE EYE. A NEW LENS WAS IMPLANTED. INSTEAD AND THE OLD LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15460152 ↗
• InjurySep 14, 2022Break; Break

  IT WAS REPORTED THE SURGEON REMOVED AND REPLACED A FULLY INSERTED INTRAOCULAR LENS (IOL) FROM THE PATIENT'S RIGHT EYE (OD) IN THE SAME PROCEDURE AFTER NOTICING THE LENS WAS BROKEN. THE PATIENT REQUIRED A VITRECTOMY, INCISION ENLARGEMENT, AND SUTURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 15415575 ↗
• InjuryAug 23, 2022Difficult to Fold, Unfold or Collapse; Failure to Fold; Difficult to Fold, Unfold or Collapse; Failure to Fold

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) FOLDED INTO THE CARTRIDGE INCORRECTLY AND WOULD NOT UNFOLD ONCE INSERTED INTO THE PATIENT'S LEFT EYE. THE INCISION WAS ENLARGED AS DOCTOR WAS UNABLE TO CUT THE IOL TO REMOVE IT. SUTURES WERE PLACED. ANOTHER LENS OF THE SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT IOL. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 15278829 ↗
• InjuryJul 21, 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 THE PATIENT COULD NOT SEE DISTANCE CLEARLY AND DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. OTHER DISORDERS OF THE EYE FOLLOWING CATARACT SURGERY LED TO EXPLANTING THE LENS. PRE-OPERATIVE VISION WAS 20/50 AND POST-OP VISION WAS 20/80. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THE PATIENT'S POST-OPERATIVE OUTCOME WAS NOT AVAILABLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Insufficient Information

  MAUDE report 15080710 ↗
• MalfunctionJul 20, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAS SCRATCHES ON POSTERIOR SURFACE OF IOL IN THE PATIENT'S LEFT EYE. NO OTHER INFORMATION WAS PROVIDED. THROUGH FOLLOW-UP, IT WAS CONFIRMED THE LENS REMAINS IMPLANTED AT THIS TIME AND SURGEON IS CONTINUING TO OBSERVED THE PATIENT. THE PATIENT HAS NOT COMPLAINED OF ANY VISUAL ISSUES. THE SCRATCHES WERE OBSERVED AT THE 6 MONTH VISIT. .NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15069001 ↗
• InjuryJun 13, 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 FULLY INSERTED INTO PATIENT'S LEFT EYE, HOWEVER, THE IOL WAS REMOVED DURING THE SAME PROCEDURE AS THE CAPSULE OPENED. THE IMPLANT WAS CUT IN HALF AND REMOVED AND REPLACED WITH ANOTHER COMPETITOR ANTERIOR CHAMBER LENS. A VITRECTOMY WAS PERFORMED. THE PATIENT'S POST-OPERATIVE STATUS WAS REPORTED AS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 14675962 ↗
• MalfunctionJun 2, 2022Break; Break

  IT WAS REPORTED THAT THE DAMAGED HAPTIC OF AN INTRAOCULAR LENS (IOL) WAS NOTED AFTER THE LENS WAS INSERTED INTO THE PATIENT'S LEFT EYE. THE IOL WAS REMOVED DURING THE SAME PROCEDURE AND ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT IOL. THERE WAS A DELAY IN THE PROCEDURE, HOWEVER, THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTION WAS REQUIRED. THERE WAS NO ISSUE AFTER PLACING THE REPLACEMENT LENS AND THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14581671 ↗
• MalfunctionMay 4, 2022Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAPTIC ARM WAS BENT AND THE DOCTOR WAS UNABLE TO INSERT THE IMPLANT FULLY INTO THE PATIENT'S OCULAR SINISTER (LEFT EYE). THERE WAS PATIENT CONTACT. NO MEDICAL OR SURGICAL INTERVENTIONS WERE NECESSARY. NO PATIENT INJURY OCCURRED. PATIENT IS REPORTEDLY DOING FINE ALTHOUGH NO LENS WAS IMPLANTED. THE IOL IS NOT AVAILABLE FOR EVALUATION AS IT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14274983 ↗