TECNIS IOL ZA9003 (REF ZA90030175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 05050474528963), received between Oct 29, 2017 and May 29, 2025 — classified as 11 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SURGEON REMOVED THE INTRAOCULAR LENS (IOL) FROM THE PATIENTS LEFT EYE AFTER NOTICING THAT IT WAS NOT CENTERED. THE SURGEON TRIED SEVERAL TIMES TO CENTER THE LENS BUT WAS NOT POSSIBLE SO DECIDED TO EXPLANT THE LENS. THE BACK UP LENS WAS INSERTED SUCCESSFULLY. THROUGH ADDITIONAL FOLLOW UP, IT WAS LEARNT THAT THE PATIENT WAS APHAKIC CAME FOR ANTERIOR VITRECTOMY AND SECONDARY IOL IMPLANTATION WITH EMERALD CARTRIDGE. THE SURGEON NOTICED THAT THE IOL WAS CENTERED POORLY AND DECIDED TO CUT THE LENS IN HALF AND REMOVED IT. THE BACK UP IOL WAS IMPLANTED AND CENTERED SUCCESSFULLY. THERE WAS NO PATIENT INJURY. PATIENT IS DOING WELL POSTOP DAY 1 AND POSTOP DAY 11. VISION HAS IMPROVED AND STABLE AND A LITTLE SORENESS. THE PRODUCT IS NOT BEING RETURNED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Pain

  MAUDE report 22109181 ↗
• InjuryMar 18, 2025Adverse 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 DUE TO THE PATIENT EXPERIENCING GLARE AND BEING UNABLE TO ADJUST TO NEAR VISION. IT WAS REMOVED AND REPLACED DURING A SECONDARY SURGICAL PROCEDURE WITH A NON-J&J LENS. THERE WAS NO INJURY AND NO INTERVENTION WAS REQUIRED. THE PATIENT IS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 21638692 ↗
• MalfunctionAug 22, 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 20035269 ↗
• InjuryAug 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED DUE TO COMPLAINTS OF DISPLACED IOL. THERE WAS NO INFORMATION PROVIDED REGARDING PATIENT VISUAL ISSUES. THE EXPLANTED IOL WAS REPLACED WITH ANOTHER JOHNSON & JOHNSON LENS, SAME MODEL IOL WITH A DIFFERENT DIOPTER SIZE, ZA9003 18.5 IOL. PLANNED VITRECTOMY AND INCISION ENLARGEMENT WERE PERFORMED HOWEVER, NO SUTURE(S) WERE REQUIRED. PATIENT OUTCOME POST-LENS EXCHANGE WAS REPORTED AS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 17547208 ↗
• MalfunctionApr 25, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) HAPTIC DETACHED AFTER DEPLOYMENT OF THE LENS INTO THE LEFT EYE. THE ISSUE WAS NOTICED AFTER INSERTION. THE LENS WAS FULLY INSERTED AND WAS THEN REMOVED AND REPLACED IN THE SAME PROCEDURE. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (SAME MODEL AND DIOPTER). THE PATIENT HAS RECOVERED. THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WAS ACTIVITIES OF DAILY LIFE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16812492 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ZA9003 INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT'S OCULAR DEXTER (RIGHT EYE). THE IOL WAS REMOVED DUE TO AN INCREASE IN AQUEOUS PRESSURE AND PUSHED FORWARD AND DID NOT ALLOW FOR ORIGINAL LENS TO BE PLACED IN THE CORRECT POSITION IN THE BAG. SINCE LENS WAS NOT IN A GOOD POSITION IT NEEDED TO BE REMOVED AND WAS REPLACED WITH A SULCUS LENS, DIOPTER SIZE UNKNOWN. IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 16561041 ↗
• MalfunctionFeb 14, 2023Failure to Fold; Material Split, Cut or Torn; Failure to Fold; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS FULLY INSERTED BUT WAS REMOVED DURING THE SAME PROCEDURE BECAUSE THERE WAS IOL TORN, FOLDING ISSUE. THEN IOL WAS REPLACED AND PROCEDURE WAS SUCCESSFULLY COMPLETED WITH BACK-UP IOL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16376630 ↗
• MalfunctionJan 12, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE RIGHT EYE AND THE TRAILING HAPTIC CAME OFF. THE EVENT WAS OBSERVED AFTER INSERTION OF THE IOL. THE IOL WAS REMOVED AND REPLACED WITH ANOTHER JOHNSON AND JOHNSON IOL (SAME MODEL, SAME DIOPTER). THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED AND NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16143428 ↗
• MalfunctionNov 2, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) SNAPPED IN HALF WHEN TRYING TO LOAD AND THERE WAS CONTACT WITH THE PATIENT'S OPERATIVE EYE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15716578 ↗
• MalfunctionOct 13, 2022Break; Difficult to Insert; Break; Difficult to Insert

  IT WAS REPORTED UPON INSERTION OF THE INTRAOCULAR LENS (IOL) INTO THE PATIENT'S LEFT EYE THE DOCTOR NOTICED THE HAPTIC WAS BENT AND WAS UNABLE TO CENTER THE IOL. THE IOL WAS EXPLANTED DURING THE SAME PROCEDURE AND REPLACED SUCCESSFULLY WITH BACK-UP LENS WITH THE SAME MODEL AND DIOPTER SIZE. THERE WAS NO MEDICAL INTERVENTION, NO PROCEDURE DELAY, NO INCISION ENLARGEMENT, NO SUTURES REQUIRED, AND NO VITRECTOMY. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15601981 ↗
• MalfunctionJun 7, 2022Break; Difficult to Insert; Break; Difficult to Insert

  IT WAS REPORTED THAT AS THE INTRAOCULAR LENS (IOL) WAS UNFOLDING IN PATIENT'S OPERATIVE EYE, JUST AFTER IMPLANTATION, IT WAS NOTED THAT THE TRAILING HAPTIC WAS BENT CAUSING THE LENS NOT TO CENTER IN THE EYE. THE LENS WAS CUT IN HALF AND REMOVED. ANOTHER LENS WAS IMPLANTED WITHOUT ISSUES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14613773 ↗
• InjuryMar 3, 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 AND REMOVED AND REPLACED IN THE SAME PROCEDURE DUE TO CAPSULAR BAG TEAR IN THE LEFT EYE. IT WAS NOTED THAT IT WAS ZERO FAULT OF THE LENS. THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 13664679 ↗
• 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 12685101 ↗
• MalfunctionAug 23, 2021Break; Break

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT'S OCULAR DEXTER (RIGHT EYE) AND REMOVED DURING THE SAME PROCEDURE DUE TO A BENT/BROKEN HAPTIC. THE PROCEDURE WAS COMPLETED USING ANOTHER IOL WITH THE SAME MODEL AND DIOPTER SIZE. PROCEDURE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE AND IT WAS REPORTED THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12356867 ↗
• InjuryApr 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZA9003 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE LEFT EYE DUE TO DYSPHOTOPSIA OBSERVED DURING POST OPERATIVE EXAMINATION.. THERE WAS NO VITRECTOMY, SUTURES OR INCISION ENLARGEMENT DURING THE PROCEDURE. THE CARTRIDGE USED WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 11648254 ↗
• MalfunctionMar 31, 2021Break; Break

  IT WAS REPORTED THAT A TECNIS INTRAOCULAR LENS (IOL) WAS FULLY INSERTED AND THE SURGEON NOTICED THE HAPTIC WAS BENT. THE LENS WAS REMOVED AND REPLACED WITH A BACKUP LENS, SERIAL NUMBER (B)(4). REPORTEDLY, THE PATIENT IS DOING FINE POST-OP. THE CUSTOMER ALSO INDICATED THAT THE LENS WAS DISCARDED AND NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11596424 ↗
• InjuryMar 23, 2021Adverse 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 VISUAL DISTURBANCE. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND HIGHER DIOPTER, 21.0) WAS IMPLANTED AS A REPLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Visual Disturbances

  MAUDE report 11558616 ↗
• InjuryJan 21, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  THE SURGERY CENTER REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S RIGHT EYE AS THE PATIENT WAS UNHAPPY WITH THE MONOFOCAL LENS. THERE WERE NO INCISION ENLARGEMENT OR SUTURES REQUIRED AND NO VITRECTOMY WAS PERFORMED. A NON-JOHNSON & JOHNSON LENS OF THE SAME DIOPTER WAS USED AS REPLACEMENT LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11210464 ↗
• InjuryJan 19, 2021Adverse 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 RIGHT EYE DUE TO REFRACTIVE SURPRISE ISSUE. THERE WAS NO VITRECTOMY PERFORMED, NO INCISION ENLARGEMENT AND/OR NO SUTURES REQUIRED. A REPLACEMENT LENS OF THE SAME MODEL BUT DIFFERENT DIOPTER (20.0) WAS USED. NO FURTHER INFORMATION WAS PROVIDE.

  Patient problems: Visual Impairment

  MAUDE report 11199001 ↗
• InjuryAug 30, 2019Break; Break

  IT WAS REPORTED THAT A ZA9003 INTRAOCULAR LENS (IOL) WHEN BEING INSERTED INTO THE EYE, HAD BROKEN HAPTIC. THE LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. THE INCISION WAS ENLARGED AND SUTURES WERE PLACED. THE PATIENT HAS RECOVERED POST-OP. THE PRODUCT WILL NOT BE RETURNED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8951829 ↗
• MalfunctionFeb 1, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A ZA9003 17.5 DIOPTER INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED WITHIN THE INITIAL PROCEDURE WHEN THE SURGEON NOTICED THE LENS HAPTIC BENT UPON INSERTION. THERE WAS NO SURGICAL INTERVENTION REQUIRED. REPORTEDLY, THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8296066 ↗
• InjuryJan 3, 2019Contamination; Contamination

  IT WAS REPORTED THAT A ZA9003, 17.5 DIOPTER INTRAOCULAR LENS (IOL), WAS REMOVED AND REPLACED DURING THE INITIAL SURGERY. WHEN THE LENS WAS BEING INSERTED THE SURGEON NOTICED LENS WAS HAZY OR TRANSLUCENT. FURTHER INFORMATION WAS PROVIDED AND STATED THERE WAS A FILM ON THE LENS. THE LENS WAS IMMEDIATELY REMOVED AND REPLACED WITH ANOTHER LENS, SAME MODEL AND SIZE. THE INCISION WAS SLIGHTLY ENLARGED AND THE PATIENT IS FINE. THERE WAS NO OTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8215671 ↗
• MalfunctionDec 28, 2017Material Discolored; Material Opacification; Device Contamination with Chemical or Other Material; Material Discolored; Material Opacification; Device Contamination with Chemical or Other Material

  IT WAS INITIALLY REPORTED THAT A MODEL ZA9003 LENS WAS INSERTED AND REMOVED FROM THE EYE. IN FURTHER COMMUNICATION, IT WAS LEARNED THAT FOLLOWING UNEVENTFUL REMOVAL OF A CATARACT, A MODEL ZA9003 17.5 DIOPTER LENS WAS INSERTED INTO THE EYE. ONCE THE LENS WAS WELL-SEATED AND CENTERED, IT WAS NOTED THAT A FLAW, OR BLEMISH WAS PRESENT IN THE LENS. THIS APPEARED TO BE SOME TYPE OF STAIN, OR CLOUDY FILM EMBEDDED IN THE LENS. SINCE IT WAS DIRECTLY IN THE VISUAL FIELD, THE LENS WAS REMOVED AND REPLACED. THE LENS WAS DIVIDED AND REMOVED THROUGH THE INCISION, AND ANOTHER ZA9003 17.5 DIOPTER LENS WAS IMPLANTED. NO WIDENING OF THE INCISION OR SUTURE WAS NECESSARY TO CLOSE THE WOUND. THERE WERE NO PROBLEMS OR ISSUES NOTED ON THE NEXT DAY¿S POST-OP VISIT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7153473 ↗
• InjuryDec 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZA9003 17.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE RIGHT EYE (OD) ON (B)(6) 2017. THE PATIENT COMPLAINS OF SEEING THE COLOR BLUE AND IT BEING IMPOSSIBLE TO FUNCTION AS AN ARTIST. AT A FOLLOW UP VISIT ON (B)(6) 2017, THE PATIENT'S VISUAL ACUITY WAS 20/20 IN BOTH EYES. AS OF THE MOST CURRENT FOLLOW UP VISIT ON (B)(\6) 2017, THE PATIENT IS STILL DECIDING WHETHER OR NOT TO EXCHANGE THE LENS. THE PATIENT'S NEXT FOLLOW UP VISIT IS MID (B)(6) 2017. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENSES IMPLANTED. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE PATIENT'S RIGHT EYE. A SEPARATE REPORT WILL BE FILED FOR THE LEFT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 7111567 ↗
• MalfunctionOct 29, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS A FOREIGN BODY ON THE INSERTER OR ON THE INTRAOCULAR LENS (IOL). THERE WAS NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS. NOTE: THIS MDR IS BEING SUBMITTED FOR THE IOL. A SEPARATE MDR WILL BE SUBMITTED FOR THE INSERTER.

  Patient problems: No Patient Involvement

  MAUDE report 6986232 ↗