TECNIS IOL ZA9003 (REF ZA90030170)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 05050474528956), received between May 4, 2017 and Oct 15, 2025 — classified as 9 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2025Material Opacification; Adverse Event Without Identified Device or Use Problem; Material Opacification; Adverse Event Without Identified Device or Use Problem

  THE ZA9003 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OPERATIVE EYE. POST-OPERATIVELY, THE PATIENT REPORTED BLURRY VISION AND A SLIT LAMP EXAM REVEALED WHITE LACY DEPOSITS CONSISTENT WITH CALCIUM SALTS ON THE ANTERIOR IOL SURFACE; SYMPTOMS PERSISTED FOR SEVEN (07) YEARS. THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A AR40E 15.5 DIOPTER IOL. DURING THE LENS EXCHANGE PROCEDURE, THERE WAS NO INCISION ENLARGEMENT, NO SUTURES, AND NO MEDICATION WAS PRESCRIBED. THE IOL DIRECTIONS FOR USE WERE NOT FOLLOWED HOWEVER, THERE WAS NO INFORMATION RECEIVED TO CLARIFY THE ISSUE. PATIENT PROGNOSIS POST LENS EXCHANGE IS UNKNOWN. PATIENT INFORMATION CANNOT BE PROVIDED DUE TO PERSONAL DATA PRIVACY LEGISLATION/POLICY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Deposits

  MAUDE report 23295244 ↗
• MalfunctionFeb 7, 2025Break; Difficult to Fold, Unfold or Collapse; Break; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT AN MONOFOCAL INTRAOCULAR LENS (IOL) WAS OPENED NOT USED DUE TO AN UNFOLDING ISSUE. THERE WAS NO PATIENT CONTACT. THROUGH FOLLOW UP IT WAS LEARNED THAT THE HAPTIC KINKED RESULTING IN AN UNFOLDING ISSUE. THE LENS WAS FULLY INSERTED IN THE PATIENT'S LEFT EYE AND WAS SUCCESSFULLY REMOVED AND REPLACED WITH ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND 17.5 DIOPTER) DURING THE SAME PROCEDURE. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21339979 ↗
• MalfunctionFeb 2, 2024Break; Break

  IT WAS REPORTED THAT A NON PRELOADED PRODUCT WITH UNKNOWN PATIENT CONTACT WAS DEFECTIVE. ADDITIONAL INFORMATION STATED THAT LENS WAS NOT USED, HAPTIC WAS KINKED BEFORE IMPLANTATION. BOX IN COMPLAINT FORM WAS MARKED YES FOR "LENS EXPLANTED DURING SECONDARY SURGERY" THOUGH NOT CONFIRMED IN FOLLOW-UP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18632870 ↗
• MalfunctionOct 2, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE HAPTIC OF THE NON-PRELOADED INTRAOCULAR LENS (IOL) BROKE OFF. ACCOUNT INDICATED THAT THE ISSUE WAS OBSERVED WHEN THE IOL WAS PLACED IN THE PATIENT'S EYE. THE IOL WAS REMOVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17858217 ↗
• MalfunctionSep 8, 2023Break; Break

  IT WAS REPORTED THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT¿S LEFT EYE. BOTH HAPTICS BROKE. LENS WAS REMOVED AND REPLACED IN THE SAME PROCEDURE DUE TO DEFECTIVE/BROKEN HAPTICS. THE LENS WAS REPLACED WITH AN ANTERIOR CHAMBER IOL. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17716578 ↗
• MalfunctionOct 10, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO STABILIZE INTRAOCULAR LENS (IOL) HAPTICS IN THE CAPSULE, THEREFORE, THE LENS WAS REMOVED. THE PATIENT WAS INFORMED HE WILL NEED TO HAVE DIFFERENT LENS ORDERED AND SURGERY FOR LENS IMPLANTED IN 1 WEEK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15571629 ↗
• MalfunctionOct 4, 2022Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD FAULTY HAPTIC AFTER THE LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15541397 ↗
• MalfunctionNov 24, 2021Break; Failure to Fold; Scratched Material; Break; Failure to Fold; Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FOLDED INCORRECTLY AND THE BAD FOLD WAS OBSERVED AFTER THE INSERTION OF THE LENS INTO PATIENT'S LEFT EYE. THE LENS WAS REMOVED FROM THE EYE AND REPLACED WITH ANOTHER LENS OF SAME MODEL AND DIOPTER. ADDITIONAL INFORMATION RECEIVED DESCRIBED THE EVENT AS BAD FOLD, THE FRONT HAPTIC BEING BENT, TRAILING HAPTIC BEING KINKED, AND LENS WAS SCRATCHED. HOWEVER THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12872788 ↗
• MalfunctionNov 23, 2021Break; Failure to Fold; Scratched Material; Break; Failure to Fold; Scratched Material

  IT WAS REPORTED THAT A ZA9003 MODEL INTRAOCULAR LENS (IOL) WAS FOLDED INCORRECTLY AND AFTER INSERTION OF THE LENS INTO THE PATIENT'S LEFT EYE, IT WAS NOTICED TO BE A BAD FOLD WHICH THE FRONT HAPTIC WAS BENT, THE TRAILING HAPTIC WAS KINKED AND THE LENS WAS SCRATCHED. THE IOL WAS REMOVED FROM THE EYE AND ANOTHER LENS OF THE SAME MODEL, BUT A DIFFERENT DIOPTER (23.0 D) WAS USED AS THE REPLACEMENT. THERE WAS NO PATIENT INJURY REPORTED AND NO OTHER INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12858826 ↗
• InjurySep 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EYE DID NOT SUPPORT A ZA9003 MODEL INTRAOCULAR LENS(IOL). LENS WAS UNSTABLE WITHIN THE EYE AND WAS REMOVED AND REPLACED IN THE SAME PROCEDURE USING AN ANTERIOR CHAMBER (AC) LENS. INCISION WAS ENLARGED AND ALSO SUTURES WERE DONE. VITRECTOMY WAS PERFORMED BEFORE THE LENS WAS PLACED IN THE PATIENT'S OPERATIVE EYE. THER WAS NO INJURY TO THE PATIENT REPORTED. NO FURTHER INFORMATION AVAILABLE.

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

  MAUDE report 12451885 ↗
• MalfunctionJul 6, 2021Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) TRAILING HAPTIC CAUGHT AND BROKE. THE LENS WAS INSERTED AND REMOVED DURING THE SAME-PROCEDURE. THE INCISION WAS NOT ENLARGED. THERE WAS NO INDICATION OF PATIENT INJURY OR THAT ANY MEDICAL OR SURGICAL INTERVENTION WERE REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12125323 ↗
• MalfunctionJun 10, 2021Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD KINKED HAPTIC. THE LENS WAS INSERTED INTO PATIENT'S LEFT EYE, HOWEVER, WAS REMOVED AND REPLACED WITH BACK-UP IOL. THE EVENT WAS OBSERVED AFTER INSERTION INTO THE EYE. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11980370 ↗
• MalfunctionApr 28, 2021Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD BENT/ BROKEN HAPTIC AND THE DOCTOR WAS UNSATISFIED WITH THE LENS AFTER INSERTION INTO PATIENT'S RIGHT EYE. THE LENS WAS TAKEN OUT. THE EVENT WAS OBSERVED AFTER INSERTION. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11737394 ↗
• MalfunctionApr 12, 2021Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS NOTICED TO HAVE THE HAPTIC RIPPED AFTER IT WAS INSERTED INTO THE EYE. THE IOL WAS TAKEN OUT AND A NEW IOL WAS PUT IN. THERE WAS NO VITRECTOMY OR SUTURES DONE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11648700 ↗
• MalfunctionMar 4, 2021Break; Break

  IT WAS REPORTED THAT A TECNIS INTRAOCULAR LENS (IOL) BACK HAPTIC KINKED UPON INSERTION. THE LENS HAD TO BE CUT OUT AND REPLACED WITH A BACKUP LENS DURING THE SAME PROCEDURE. THERE IS NO ADDITIONAL SURGICAL INTERVENTION PERFORMED AND NO INJURY REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11415528 ↗
• MalfunctionFeb 10, 2021Break; Break

  IT WAS REPORTED THAT A ZA9003 INTRAOCULAR LENS (IOL) WAS FULLY INSERTED IN THE RIGHT EYE (OD). THERE WAS A BROKEN HAPTIC. THE LENS WAS REMOVED AND REPLACED. THE PROCESS WAS COMPLETED SUCCESSFULLY WITH ANOTHER ZA9003 LENS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11308069 ↗
• InjuryJan 8, 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 LEFT EYE DUE TO VISUAL DISTURBANCE. IT WAS STATED THAT THE INCISION WAS ENLARGED. THE IOL WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL, LOWER DIOPTER SIZE (16.5). IT WAS NOTED THAT THERE IS NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 11137506 ↗
• InjuryMay 2, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE DUE TO ANTERIOR DISLOCATION OF THE LENS. THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8571894 ↗
• MalfunctionMar 1, 2019Break; Break

  IT WAS REPORTED THAT A ZA9003 MONOFOCAL INTRAOCULAR LENS WAS DAMAGED WHILE INSERTING IN THE EYE. REPORTEDLY THERE WAS NO PATIENT INJURY AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8384169 ↗
• InjuryJan 24, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A ZA9003 17.0 DIOPTER INTRAOCULAR LENS (IOL) WAS INSERTED AND REMOVED DURING THE SAME SURGICAL PROCEDURE BECAUSE THE LENS HAD A BENT HAPTIC - TORE THE PATIENT'S CAPSULAR BAG. THERE WAS NO INCISION ENLARGEMENT AND NO SUTURES USED, BUT AN ANTERIOR VITRECTOMY WAS REQUIRED. THE LENS WAS CUT OUT OF THE EYE AND A NEW LENS WAS IMPLANTED. IT WAS INDICATED THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 8276740 ↗
• InjuryFeb 16, 2018Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF A ZA9003 17.0 DIOPTER INTRAOCULAR LENS (IOL) WAS NOTICED BROKEN AFTER THE LENS WAS IMPLANTED. THEREFORE, IT WAS REMOVED AND REPLACED DURING THE SAME SURGICAL PROCEDURE. AN INCISION ENLARGEMENT WAS MADE AND SUTURES WERE USED. THERE WAS NO PATIENT INJURY. REPORTEDLY, THE REPLACEMENT LENS WAS THE SAME MODEL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7279088 ↗
• InjuryJul 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED HAVING INTRAOCULAR LENS (IOL) ZA9003 IMPLANTED IN HER RIGHT EYE ON (B)(6) 2012. POST SURGERY PATIENT CLAIMED THE LENS DID NOT CORRECT HER VISION, DID NOT GAVE ANY MID- OR NEAR RANGE VISION AND THAT THE IOL WAS A SILICON BASED AND SHE HAD AN ALLERGY TO SILICON-BASED PRODUCTS. THE IOL WAS EXPLANTED AND A MONOFOCAL IOL MADE BY RAYNER (MANUFACTURER) WAS IMPLANTED (2ND LENS). THE 2ND LENS ROTATED, TILTED AND FINALLY FELL OUT OF BAG SO IT HAD TO BE REMOVED AND A 3RD LENS WAS IMPLANTED. THE 3RD LENS REMAINS IMPLANTED HOWEVER, IT ALSO REQUIRED INTERVENTION TO KEEP IN PLACE AND WAS REPORTED UNDER MEDWATCH NUMBER 9614546-2017-00542. THIS REPORT IS FOR THE 1ST IOL THAT WAS EXPLANTED.

  Patient problems: No Code Available; Reaction

  MAUDE report 6699775 ↗
• InjuryMay 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CATARACT PATIENT UNDERWENT INTRAOCULAR LENS (IOL) IMPLANTATIONS IN (B)(6) 2015 IN BOTH EYES. POST IMPLANT(S) THE PATIENT COMPLAINED OF MONO-OCULAR VERTICAL DOUBLE IMAGES/GHOST IMAGES WITH BOTH EYES. CONTACT LENSES WITH ASTIGMATISM CORRECTION WERE USED TO TRY TO RESOLVE THE ISSUE. DURING FOLLOW UP THE ACCOUNT REPORTED THERE IS NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA) EQUAL TO OR ABOVE 2 LINES OR INDUCED ASTIGMATISM OF 2 OR MORE DIOPTERS. THEY ALSO REPORTED THERE HAS BEEN NO SECONDARY SURGICAL OPERATION BEING PERFORMED OR THAT THE ASTIGMATISM HAD INCREASED IN SEVERITY. THEY INDICATED THAT THE SYMPTOMS ARE SIGNIFICANTLY INTERFERING WITH ACTIVITIES OF DAILY LIVING DESPITE THE USE OF SPECTACLES. FINALLY THE ACCOUNT MENTIONED THAT THE ASTIGMATISM IS NOT RELATED TO THE SURGICAL PROCEDURE. BOTH LENSES REMAIN IMPLANTED. SINCE BOTH EYES WERE AFFECTED THIS REPORT IS FOR THE OTHER IOL FOR ONE OF THE EYES. A SEPARATE REPORT IS BEING SUBMITTED FOR THE ONE IOL FOR THE OTHER EYE.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6543109 ↗
• InjuryMay 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CATARACT PATIENT UNDERWENT INTRAOCULAR LENS (IOL) IMPLANTATIONS IN (B)(6) 2015 IN BOTH EYES. POST IMPLANT(S) THE PATIENT COMPLAINED OF MONO-OCULAR VERTICAL DOUBLE IMAGES/GHOST IMAGES WITH BOTH EYES. CONTACT LENSES WITH ASTIGMATISM CORRECTION WERE USED TO TRY TO RESOLVE THE ISSUE. DURING FOLLOW UP THE ACCOUNT REPORTED THERE IS NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA) EQUAL TO OR ABOVE 2 LINES OR INDUCED ASTIGMATISM OF 2 OR MORE DIOPTERS. THEY ALSO REPORTED THERE HAS BEEN NO SECONDARY SURGICAL OPERATION BEING PERFORMED OR THAT THE ASTIGMATISM HAD INCREASED IN SEVERITY. THEY INDICATED THAT THE SYMPTOMS ARE SIGNIFICANTLY INTERFERING WITH ACTIVITIES OF DAILY LIVING DESPITE THE USE OF SPECTACLES. FINALLY THE ACCOUNT MENTIONED THAT THE ASTIGMATISM IS NOT RELATED TO THE SURGICAL PROCEDURE. BOTH LENSES REMAIN IMPLANTED. SINCE BOTH EYES WERE AFFECTED THIS REPORT IS FOR ONE OF THE IOL¿S FOR ONE OF THE EYES. A SEPARATE REPORT IS BEING SUBMITTED FOR THE OTHER IOL FOR THE OTHER EYE.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6543108 ↗