TECNIS IOL ZA9003 (REF ZA90030240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 05050474529090), received between Nov 17, 2016 and Nov 12, 2025 — classified as 8 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAPTIC BROKE WHILE THE SURGEON WAS ADVANCING THE METAL PLUNGER. THE IOL WAS INSERTED INTO THE PATIENT'S EYE AND IT WAS REMOVED IN THE SAME PROCEDURE. A BACK-UP LENS WAS USED AS THE REPLACEMENT IOL. ACCOUNT INDICATED A PROLONGED SURGERY TIME DUE TO THE EVENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23536389 ↗
• MalfunctionOct 30, 2025Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23432864 ↗
• MalfunctionMay 16, 2025Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038034 ↗
• InjuryNov 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON(JNJ) INTRAOCULAR LENS (IOL) IS CAUSING THE PATIENT THE INABILITY TO DRIVE OR DO ANYTHING. PATIENT IS EXPERIENCING CLOUDY VISION AND AN EYE INFECTION WHICH SHE¿S HAD FOR THE PAST 9 MONTHS IN HER LEFT EYE. TAKING MOXIFLOXACIN AN ANTIBIOTIC. SHE WAS ALSO PRESCRIBED ERYTHROMYCIN WHICH SHE REPORTED NOT USING BECAUSE SHE DIDN¿T NEED IT. THE PATIENT WAS REFERRED TO HER DOCTOR AS JNJ IS NOT ALLOWED TO PROVIDE MEDICAL ADVICE. HER SURGEON HAS ALREADY TOLD HER THAT SHE MUST WAIT FOR THE HEALING PROCESS. THE PATIENT SAID SHE¿S HAD ONGOING ISSUES SUCH AS EYE DISCHARGE FROM HER SURGERY BACK IN (B)(6) OF 2023. SHE SAID JNJ SHOULD KNOW THAT ¿AFTER EYE SURGERY THERE ARE PROBLEMS, AND IT TAKES A WHILE TO HEAL¿ AND STATED THAT SHE KNOWS THE EYE INFECTION IS FROM THE LENS BECAUSE IT BEGAN RIGHT AFTER SURGERY. THE INFECTION WENT AWAY FOR A WHILE THEN CAME BACK IN (B)(6) 2023. CLEARED-UP AND CAME BACK AGAIN. REPORTEDLY, THE INFECTION CONTINUES TO DATE. THE PATIENT EXPLAINED SHE HAS BEEN PRESCRIBED MEDICATIONS WHICH DON¿T HELP. SHE CAN¿T DRIVE RIGHT NOW. THE PATIENT EXPLAINED THAT THE INABILITY TO DRIVE STARTED RIGHT AFTER SURGERY SINCE YOU ARE RECOVERING. SHE

  Patient problems: Blurred Vision; Eye Infections; Eye Irritation; Unspecified Eye / Vision Problem; Visual Disturbances

  MAUDE report 18223657 ↗
• MalfunctionSep 26, 2023Break; Break

  IT IS REPORTED THAT THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) HAPTIC WAS BENT UPON INSERTION, CAUSING DIFFERENT LENS TO BE IMPLANTED. LENS FROM ANOTHER MANUFACTURER WAS IMPLANTED WITHOUT PATIENT INJURY OR MEDICAL OR SURGICAL INTERVENTION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17819070 ↗
• MalfunctionJun 22, 2023Break; Difficult to Fold, Unfold or Collapse; Break; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT THE LOOP OF THE INTRAOCULAR LENS (IOL) CAME OUT OF THE CARTRIDGE WITH AN UNNATURAL BEND AND DID NOT STRETCH ONCE INSERTED INTO THE CAPSULAR BAG. ANOTHER IOL WAS INSERTED DURING THE SAME PROCEDURE. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17187727 ↗
• MalfunctionApr 5, 2023Break; Difficult to Insert; Break; Difficult to Insert

  IT WAS REPORTED THAT AFTER FULLY INSERTING AN INTRAOCULAR LENS (IOL) INTO A PATIENT¿S RIGHT EYE, THE SURGEON NOTICED THAT THE LENS WAS RIPPLED AND DID NOT LIKE POSITION OF THE LENS. THE SURGEON USED STEINERT II LENS FOLDING FORCEPS TO REMOVE THE LENS. POSTED PROCEDURE DONE WERE INDICATED TO BE 25 GAUGE VITRECTOMY, INTRAOCULAR LENS EXCHANGE, AND ENDOLASER. A NON-JOHNSON AND JOHNSON LENS OF 23.5 DIOPTER WAS USED AS A REPLACEMENT. THE PROCEDURE COMPLETED SUCCESSFULLY WITH NO PATIENT INJURY REPORTED. NO MEDICAL INTERVENTIONS REQUIRED. THE PATIENT TOLERATED PROCEDURE WELL AND WAS TRANSPORTED TO POST ANESTHESIA CARE UNIT (PACU). ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THERE WAS NO CAPSULE TEAR, THE VITRECTOMY WAS PLANNED WHICH WAS PERFORMED DURING THIS SAME PROCEDURE. IT WAS NOTED THAT THE SURGEON'S OPERATIONAL NOTE INDICATED THAT "INSPECTION OF THE RETINA UNDER THE RESIGHT VIEWING SYSTEM REVEALED AN ALREADY PRESENT POSTERIOR VITREOUS DETACHMENT. THE ENDOLASER WAS USED FOR THE DETACHMENT." THIS WAS COMPLETED PRIOR TO LENS EXCHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Retinal Detachment

  MAUDE report 16685897 ↗
• MalfunctionJul 8, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHILE IMPLANTING THE LENS, THE SURGEON NOTICED THE LENS WAS TORN NEAR THE TRAILING HAPTIC. THE LENS WAS CUT INTO THREE PIECES AND REMOVED. A REPLACEMENT LENS SAME MODEL AND DIOPTER SIZE WAS INSERTED. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES DONE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14961192 ↗
• 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 12683417 ↗
• MalfunctionOct 20, 2021Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT THE HAPTIC OF THE INTRAOCULAR LENS (IOL) WAS BENT UPON INSERTION. THE LENS WAS PARTIALLY INSERTED INTO PATIENT'S RIGHT EYE; HOWEVER, IT WAS REMOVED FROM THE EYE. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12669490 ↗
• MalfunctionSep 20, 2021Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS REMOVED FROM THE PATIENT'S RIGHT EYE AS IT WAS OBSERVED WITH A BROKEN HAPTIC AFTER IT WAS FULLY INSERTED INTO THE EYE. PATIENT WAS REPORTEDLY DOING GREAT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12502962 ↗
• MalfunctionMar 24, 2021Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD LOADING AND THE HAPTIC WAS BENT OR BROKEN. THE LENS WAS NOT IN CONTACT, ONLY THE CARTRIDGE TIP MADE CONTACT WITH THE PATIENT'S LEFT EYE. THE PROCEDURE WAS COMPLETED USING ANOTHER LENS OF SAME MODEL. THE EVENT WAS OBSERVED WHEN INSERTING INTO THE EYE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11566342 ↗
• MalfunctionMar 22, 2021Break; Break

  IT WAS REPORTED THAT A ZA9003 MODEL INTRAOCULAR LENS(IOL) HAD BENT/BROKEN HAPTIC. LENS WAS FULLY IMPLANTED INTO THE PATIENT'S LEFT EYE AND WAS REMOVED IN THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER LENS OF SAME MODEL AND DIOPTER. NO MEDICAL/ SURGICAL INTERVENTIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY OR SUTURES WERE PERFORMED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11543880 ↗
• InjuryMar 18, 2020Break; Break

  IT WAS REPORTED THAT AFTER INSERTION OF A MODEL ZA9003 INTRAOCULAR LENS (IOL) INTO THE PATIENT'S RIGHT EYE, THE HAPTIC BROKE OFF AND THE CAPSULAR BAG TORE. THE LENS WAS NOT REPLACED AS THE PATIENT'S CAPSULAR BAG WAS NOT STABLE ENOUGH. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Capsular Bag Tear; No Code Available

  MAUDE report 9846200 ↗
• MalfunctionOct 2, 2019Contamination; Contamination

  IT WAS REPORTED THAT AFTER THE ZA9003 INTRAOCULAR LENS (IOL) WAS IMPLANTED, THERE WERE WHITE SUBSTANCE OBSERVED ON THE EDGE OF THE LENS. IT WAS INDICATED THAT PART OF THE WHITE SUBSTANCE WAS REMOVED; HOWEVER, THE DOCTOR DID NOT COLLECT IT TO BE RETURNED FOR EVALUATION. THE DOCTOR WAS ABLE TO COMPLETE THE SURGERY, AND NO PATIENT INJURY OR POST-OP ISSUE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9148205 ↗
• InjurySep 5, 2019Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS IMPLANTED AND REMOVED DURING SAME-DAY PROCEDURE AS THE LENS WOULD NOT HOLD IN THE PATIENT'S SULCUS. THERE WAS NO REPLACEMENT LENS AT THAT TIME. THE PATIENT REQUIRED AN INCISION ENLARGEMENT, SUTURES, AND A VITRECTOMY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 8964422 ↗
• MalfunctionJan 9, 2019Break; Break

  IT WAS REPORTED THAT ONE OF THE HAPTICS OF THE ZA9003 TECNIS MONOFOCAL IOL (INTRAOCULAR LENS) WAS OBSERVED TO BE BROKEN WHEN REMOVING THE LENS FROM THE PACKAGING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8230714 ↗
• InjuryDec 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZA9003 24.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO THE PATIENT BEING UNABLE TO TOLERATE MYOPIA AND ENDED UP -1.75. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY PERFORMED, AND NO SUTURE(S) USED. THE REPLACEMENT LENS WAS THE SAME MODEL. REPORTEDLY, THE PATIENT OUTCOME WAS GOOD AND THERE WAS STILL SOME GLARE AT NIGHT, BUT MUCH IMPROVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8183334 ↗
• MalfunctionAug 30, 2018Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF A ZA9003 24.0 DIOPTER LENS WAS KINKED/BROKEN. IT IS UNKNOWN WHEN THIS EVENT OCCURRED AND IF THERE WAS PATIENT CONTACT OR NOT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7831981 ↗
• InjuryJul 26, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (MODEL ZA9003 +24.0 DIOPTER) WAS IMPLANTED INTO THE LEFT EYE (OS) OF THE PATIENT ON (B)(6) 2011. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO LENS DISLOCATION. REPORTEDLY, THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7723118 ↗
• InjuryDec 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZA9003 24.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017, BECAUSE THE PATIENT EXPERIENCED A REFRACTIVE ERROR WITH ASTIGMATISM. THERE WAS NO INCISION ENLARGEMENT, SUTURES OR PATIENT INJURY. THE REPLACEMENT LENS WAS A DIFFERENT MODEL (TORIC IOL). REPORTEDLY, THE GOAL WAS TO GET THE PATIENT BETWEEN -1.0 AND PLANO; HOWEVER, RESULTS WERE -1.12 WITH 1.0 OF ASTIGMATISM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7119309 ↗
• MalfunctionMay 25, 2017Torn Material; Torn Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS STUCK AND TORE DURING INSERTION. THE IOL WAS REMOVED AND REPLACED WITH ANOTHER ONE. THERE WAS A DELAY OF ABOUT 5-10 MINUTES. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6591587 ↗
• InjuryApr 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INCISION HAD TO BE ENLARGED ON THE LEFT EYE (OS) OF A MALE PATIENT IN ORDER TO REMOVE THE IMPLANTED INTRAOCULAR LENS (IOL), MODEL ZA9003 WITHIN THE SAME SURGICAL PROCEDURE. IT WAS REPORTED THAT THE POSTERIOR CAPSULE BAG TORE; HOWEVER, IT WAS CONFIRMED THAT THE CAPSULE TEAR WAS DUE TO PATIENT ANATOMY ISSUE AND IT WAS NOT RELATED TO THE LENS OR ANY OF THE AMO PRODUCTS. THE DOCTOR CLAIMED THAT THERE WAS NO CAPSULAR SUPPORT HENCE, HE HAD TO DO INCISION ENLARGEMENT TO REMOVE THE LENS AND VITRECTOMY WAS ALSO PERFORMED. IT WAS INDICATED THAT THERE WAS NO REPLACEMENT LENS USED AND THAT THE PATIENT WENT HOME APHAKIC. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; No Code Available; Vitrectomy

  MAUDE report 6491429 ↗
• InjuryNov 17, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZA9003 24.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO PATIENT'S ANATOMY NOT WORKING WITH THE LENS. THE LENS WAS CUT OUT AND REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6108405 ↗