TECNIS IOL ZA9003 (REF ZA90030235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 05050474529083), received between Sep 8, 2016 and Jul 9, 2025 — classified as 15 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Break” (24 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 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2025Break; Break

  IT WAS REPORTED THAT A NON-PRELOADED INTRAOCULAR LENS (IOL) HAD A BROKEN HAPTIC IDENTIFIED DURING HANDLING, PRIOR TO INSERTION AND THERE WAS NO PATIENT INVOLVEMENT. HOWEVER, UPON FURTHER FOLLOW UP, IT WAS STATED THAT THE LENS HAD A BROKEN HAPTIC WHILE INSERTING IT INTO THE EYE AND LENS WAS PARTIALLY INSERTED. THERE WAS NO INJURY CAUSED AND NO FURTHER MEDICAL INTERVENTION. THE PROCEDURE WAS COMPLETED WITH A BACKUP LENS. NO FURTHER INFORMATION IS AVAILABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22464159 ↗
• MalfunctionNov 4, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20603084 ↗
• MalfunctionOct 28, 2024Break; Break

  IT WAS REPORTED THAT THE STANDALONE 3 PIECE MONOFOCAL INTRAOCULAR LENS (IOL) WAS BROKEN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20549379 ↗
• MalfunctionSep 26, 2024Material Fragmentation; Material Fragmentation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20315339 ↗
• MalfunctionAug 21, 2024Break; Break

  IT WAS REPORTED THAT SEVERAL MONOFOCAL INTRAOCULAR LENSES (IOLS) WERE DEFECTIVE. IT WAS UNKNOWN IF THERE WAS PATIENT CONTACT OR NOT. NO OTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO THE SUSPECT IOL MODEL ZA9003/ SERIAL NUMBER (B)(6). A SEPARATE REPORT WILL BE SUBMITTED FOR THE OTHER 5 SUSPECT IOLS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20009456 ↗
• MalfunctionAug 12, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED, THAT THE HAPTIC CAME OFF THE STANDALONE MONOFOCAL INTRAOCULAR LENS (IOL). BEFORE INSERTION INTO THE PATIENT'S EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19964859 ↗
• MalfunctionDec 11, 2023Break; Break

  IT WAS REPORTED THAT THE TECNIS NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAD A BROKEN HAPTIC AND WAS REMOVED DURING THE SAME PROCEDURE . NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18302006 ↗
• MalfunctionNov 22, 2023Break; Break

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18196989 ↗
• MalfunctionNov 22, 2023Break; Break

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18196973 ↗
• InjuryApr 29, 2023Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS "DEFECTIVE". IMPLANTED BUT REMOVED. IT IS ALSO NOTED THAT THE PATIENT WAS UNABLE TO TOLERATE THE LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16841229 ↗
• MalfunctionDec 15, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) AND HAPTICS DID NOT UNFOLD CORRECTLY. THE LENS WAS IN CONTACT WITH THE PATIENT. NO FURTHER DETAILS WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15992670 ↗
• MalfunctionDec 7, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED AND REMOVED FROM PATIENT'S RIGHT EYE AS THE FRONT HAPTIC WAS BENT. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. NO OTHER INTERVENTION WAS REQUIRED. THERE WAS NO PATIENT INJURY AND THE PATIENT WAS DOING FINE POST OPERATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15936000 ↗
• MalfunctionNov 8, 2022Break; Break

  IT WAS REPORTED THAT THE LENS WAS INSERTED INTO THE PATIENT¿S LEFT EYE WHEN THE SURGEON OBSERVED A CHIP OUT OF THE EDGE OF THE LENS. THE LENS WAS REMOVED FROM THE EYE AND ANOTHER JOHNSON & JOHNSON LENS WITH THE SAME MODEL AND DIOPTER IMPLANTED. THERE WERE NO SURGICAL AND/OR MEDICAL INTERVENTIONS REQUIRED, AND NO PATIENT INJURY REPORTED. IT WAS INDICATED THAT THE PATIENT SEEMED TO BE FINE WHEN THE LEFT AND THEY WERE SCHEDULED FOR A POST-OP VISIT OF (B)(6) 2022. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15756757 ↗
• MalfunctionSep 2, 2022Break; Break

  IT WAS REPORTED THAT THE REAR HAPTIC OF THE INTRAOCULAR LENS (IOL) LOOKED OVER CURLED IN THE PACKAGE. REMOVED THE IOL FROM THE PACKAGE AND REPLACED IN PACKAGE, AND THE HAPTIC SPRUNG BACK INTO PLACE. THE IOL WAS LOADED AND INSERTED INTO THE PATIENT'S LEFT EYE. UNDER THE MICROSCOPE IT WAS NOTICED THAT THE LENS HAD A DEFECT NEXT TO THE TRAILING HAPTIC. THE LENS WAS REMOVED AND REPLACED. THERE WAS NO INCISION ENLARGEMENT REQUIRED AND THERE WERE NO ADVERSE EFFECTS ON THE PATIENT. THE SURGEON HAD TO CHANGE TECHNIQUE. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE LENS HAD A "DIVOT" LOCATED ON THE OPTIC OF THE LENS THAT DID NOT LOOK RIGHT. THE ISSUE WAS NOT NOTICED UNTIL THE LENS WAS FULLY INSERTED AND THE LENS WAS LOOKED AT UNDER A MICROSCOPE. THE IOL WAS FULLY INSERTED AND REMOVED AND REPLACED WITHIN THE SAME PROCEDURE. ANOTHER JOHNSON & JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (SAME MODEL, SAME DIOPTER). THE CHANGE OF TECHNIQUE WAS CONFIRMED TO BE THAT THE SURGEON HAD TO CUT THE LENS IN HALF AND REMOVE IT, WHICH WOULD NORMALLY NOT BE REQUIRED IF THERE WAS NO ISSUE. NO SUTURES, VITRECTOMY, OR ANY OTHER MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED. THE PATIENT HAS NO ISSUES POST-OPERATIVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15349680 ↗
• InjuryApr 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 A PATIENT'S LEFT (OS) EYE DUE TO REFRACTIVE SURPRISE, MYOPIA. THE PATIENT'S DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. THE PATIENT WAS PRESCRIBED MEDICATION (PMN), DETAILS WERE NOT PROVIDED. THE REPLACEMENT LENS MODEL IS UNKNOWN/NOT PROVIDED. THERE WAS NO DELAY REPORTED. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 14037865 ↗
• MalfunctionMar 4, 2022Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13676489 ↗
• InjuryOct 18, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT A ZA9003 MODEL INTRAOCULAR LENS(IOL) WAS INSERTED AND REMOVED IN THE SAME PROCEDURE AS LENS WOULD NOT SIT WELL IN PATIENT'S RIGHT EYE. SUTURES AND VITRECTOMY WAS DONE. PROCEDURE WAS COMPLETED SUCCESSFULLY USING A COMPETITOR'S LENS. PATIENT IS DOING FINE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 12648396 ↗
• MalfunctionJun 29, 2021Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT A ZA9003 MODEL INTRAOCULAR LENS(IOL) HAD BENT HAPTIC AND CUSTOMER SAID THEY ALSO HAVE ISSUES LOADING THE LENS. THERE WAS PATIENT CONTACT. THE EVENT WAS OBSERVED WHILE INSERTING THE LENS INTO THE PATIENT'S RIGHT EYE. ADDITIONAL DETAILS RECEIVED STATES THAT EXTENT OF PATIENT CONTACT IS UNKNOWN AND THAT THERE WAS NO INJURY AND NO MEDICAL/SURGICAL INTERVENTIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY OR SUTURES WERE PERFORMED. PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12089619 ↗
• InjuryJun 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 PATIENT'S LEFT EYE DUE TO REFRACTIVE SURPRISE. ANOTHER LENS OF SAME MODEL BUT DIFFERENT DIOPTER (22.0 D) WAS PLACED AS THE REPLACEMENT LENS. THE REPORTED ISSUE WAS OBSERVED DURING POST-OP EXAMINATION. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 12014166 ↗
• MalfunctionMay 18, 2021Material Opacification; Material Opacification

  IT WAS REPORTED THAT AFTER A ROUTINE APPOINTMENT, THE DOCTOR OBSERVED THE ZA9003 MODEL INTRAOCULAR LENS(IOL) IS OPAQUE AND THE DOCTOR IS THINKING ABOUT EXPLANTING THE IOL. THE EVENT WAS OBSERVED AFTER IMPLANTATION OF THE LENS. DAILY ACTIVITIES OF THE PATIENT ARE SIGNIFICANTLY AFFECTED AND THE PATIENT IS TEMPORARILY IMPAIRED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 11846000 ↗
• MalfunctionMay 13, 2021Break; Device Contaminated During Manufacture or Shipping; Break; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED, HOWEVER, THERE WAS DEBRIS ON THE LENS WHICH APPEARED TO BE AN EXTRA HAPTIC ON THE OPTIC MATERIAL OBSERVED AFTER INSERTION OF THE LENS. THE HAPTIC IS SHAPED, BUT CLEAR IN COLOR. THE SURGEON WAS ABLE TO REMOVE WITH FORCEPS. THE EXTRA MATERIAL AND DEBRIS HAVE BEEN DISCARDED. AT THIS TIME THE LENS REMAINS IMPLANTED. THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11816355 ↗
• MalfunctionApr 12, 2021Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) ONCE IT WAS IN THE EYE, THE HAPTIC BENT. THE IOL WAS THEN REMOVED AND REPLACED. THERE WAS NO VITRECTOMY AND NO SUTURES. IT WAS ALSO STATED THAT THERE WAS DELAY IN PROCEDURE BUT FOLLOW-UP CONFIRMED THAT THE PROCEDURE JUST TOOK LONGER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11648592 ↗
• InjuryFeb 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE LENS WAS IMPLANTED IN THE PATIENT'S OCULAR SINISTER (LEFT EYE) . THE LENS WAS EXPLANTED DUE TO COMPLAINTS OF REFRACTIVE SURPRISE. THE LENS WAS REPLACED WITH A DIFFERENT MODEL LENS WITH A DIFFERENT DIOPTER SIZE. THERE WAS NO MEDICAL INTERVENTION AND PATIENT OUTCOME INFORMATION WAS NOT PROVIDED. THERE IS NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 11335807 ↗
• MalfunctionFeb 2, 2021Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD BENT HAPTIC. IT WAS UNSURE IF THEY WERE BENT UPON OPENING OR AFTER BEING LOADED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11270290 ↗
• MalfunctionJan 22, 2021Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) DURING INSERTION, THE TRAILING HAPTIC BENT. IT WAS LEARNED THAT THERE WAS NO ADVERSE REACTIONS TO REPORT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11213304 ↗