TECNIS IOL ZA9003 (REF ZA90030165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 05050474528949), received between Aug 26, 2016 and Jul 9, 2025 — classified as 13 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (8 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.

• 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 22464131 ↗
• InjuryJun 7, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO IOL DISLOCATION. PARS PLANA VITRECTOMY (PPV), YAMANE TECHNIQUE, LIMBAL RELAXING INCISIONS (LRI) PERFORMED. THERE WAS NO INCISION ENLARGEMENT REQUIRED. EXPLANTED IOL WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL. THE PATIENT OUTCOME IS GOOD, AND NO INJURY REPORTED. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 17083298 ↗
• MalfunctionNov 17, 2022Break; Break

  IT WAS REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) WAS FULLY INSERTED, THE DOCTOR NOTICED A BROKEN HAPTIC. THE LENS WAS REMOVED AND ANOTHER JOHNSON & JOHNSON LENS BACKUP LENS WITH THE SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. THERE WERE NO MEDICAL OR SURGICAL INTERVENTIONS REPORTED. THE PATIENT WAS REPORTED TO BE DOING FINE AND NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15820490 ↗
• InjuryOct 25, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A NON-PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE DUE TO THE LENS WAS DISPLACED POST-OPERATIVELY. REGARDING HOW LONG THE ISSUE PERSISTED, THE CUSTOMER RESPONDED IT OCCURRED DURING THE TIME BETWEEN SURGERIES. AN UNPLANNED VITRECTOMY WAS PERFORMED. CUSTOMER ALSO STATED NO SUTURES WERE REQUIRED, NO INCISION ENLARGEMENT, NO PRESCRIBED MEDICATION. THEY INDICATED THAT THE DIRECTIONS FOR USE WERE FOLLOWED. THE REPLACEMENT IOL IS THE SAME MODEL LENS WITH THE SAME DIOPTER POWER.

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

  MAUDE report 15671284 ↗
• MalfunctionOct 24, 2022Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAPTIC WAS TWISTED WHILE INJECTING INTO THE PATIENT'S ANTERIOR CHAMBER. THE IOL WAS NOT FULLY INSERTED. IOL WAS REMOVED AND NEW IOL WAS USED TO COMPLETE THE SURGERY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15658878 ↗
• MalfunctionOct 10, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT THERE WERE SCRATCHES ON AN INTRAOCULAR LENS (IOL) IN THE PATIENT'S LEFT EYE. PICTURE PROVIDED SHOWED LENS IN THE EYE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15573132 ↗
• MalfunctionOct 13, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE SURGEON IS SEEING SCRATCHES/STRIATIONS ALL OVER THREE TECNIS INTRAOCULAR LENSES (IOLS). THE SURGEON IS NOT SEEING THEM IN THE MICROSCOPE, BUT HIS DOCTOR OF OSTEOPATHY (ODS) ARE SEEING THEM IN THE SLIT LAMP. THE LENSES REMAIN IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED. NOTE: THIS COMPLAINT FOLDER CAPTURES SERIAL (B)(4). THE OTHER SERIAL NUMBERS ARE BEING CAPTURED IN SEPARATE MEDWATCH REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12624383 ↗
• MalfunctionAug 19, 2021Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD A BENT/BROKEN HAPTIC. THE LENS WAS FULLY INSERTED IN THE LEFT EYE AND REPLACED DURING THE SAME PROCEDURE. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12345252 ↗
• MalfunctionJul 30, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE DOCTOR SAW A RIP IN THE INTRAOCULAR LENS (IOL) WHEN HE WENT TO INSERT THE LENS INTO THE PATIENT'S OPERATIVE EYE. THERE WAS PATIENT CONTACT AND THE PROCEDURE WAS COMPLETED USING A REPLACEMENT LENS. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12256196 ↗
• InjuryJul 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZA9003 MODEL INTRAOCULAR LENS(IOL) WAS FULLY INSERTED INTO PATIENT'S OPERATIVE EYE AND WAS REMOVED IN THE SAME PROCEDURE AND VITRECTOMY WAS DONE ON PATIENT. ADDITIONAL DETAILS RECEIVED STATES THAT THERE WAS NO INJURY TO THE PATIENT. THERE WAS NO ISSUE WITH THE LENS AND IT WAS REMOVED BECAUSE PATIENT WAS NOT COOPERATIVE AND WAS MOVING A LOT, PATIENT HAS DEMENTIA, AND DOCTOR NEEDED AN IOL THAT WAS HALF OF DIOPTER SMALLER SO IT WOULD SIT WELL IN THE EYE. PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS. NO ADDITIONAL MEDICAL/ SURGICAL INTERVENTIONS WERE PERFORMED. PATIENT WAS DOING FINE AT THE TIME OF DISCHARGE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12207121 ↗
• InjuryJun 21, 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 PATIENT'S LEFT EYE (OS) BECAUSE HE HAD BLURRY VISION. IT WAS OBSERVED DURING POST OPERATIVE EXAMINATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NON- JOHNSON AND JOHNSON LENS. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 12038092 ↗
• MalfunctionMay 26, 2021Break; Break

  THE SURGERY CENTER REPORTED DEFECTIVE INTRAOCULAR LENS (IOL). THE LENS WAS INSERTED AND REMOVED IN THE SAME PROCEDURE. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO SURGICAL INTERVENTION REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11883115 ↗
• MalfunctionMar 22, 2021Break; Failure to Fold; Use of Device Problem; Difficult to Advance; Break; Failure to Fold; Use of Device Problem; Difficult to Advance

  IT WAS REPORTED THAT A ZA9003 MODEL INTRAOCULAR LENS(IOL) HAD LOADING ISSUES AND LEAD HAPTIC WAS FOLDED IN/ BENT . THE LENS WAS PARTIALLY INSERTED INTO THE PATIENT'S LEFT EYE AND WAS REMOVED IN THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS OF SAME MODEL AND DIOPTER. THIS EVENT WAS OBSERVED WHILE INSERTING THE LENS INTO PATIENT'S EYE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11544386 ↗
• MalfunctionJan 20, 2021Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD DEFECT AT THE EDGE OF THE OPTIC. THERE WAS PATIENT CONTACT WITH LENS THAT IT WAS PARTIALLY INSERTED. THERE WAS NO INJURY AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED USING ANOTHER LENS OF SAME MODEL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11206185 ↗
• InjurySep 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS OPENED BUT NOT USED. THERE WAS PATIENT CONTACT WITH THE IOL AND THAT AN UNPLANNED VITRECTOMY WAS PERFORMED. IT WAS STATED THAT A DIFFERENT IOL WAS USED INSTEAD. THE SUSPECT PRODUCT WAS DISCARDED. NO OTHER INFORMATION WAS RECEIVED.

  Patient problems: Vitrectomy

  MAUDE report 10533215 ↗
• InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHILE INSERTING LENS INTO THE PATIENT'S LEFT EYE THERE WAS CAPSULAR TEAR. REPORTEDLY VITRECTOMY AND SUTURES WERE REQUIRED. PACKAGING WAS SEALED WHEN CUSTOMER RECEIVED LENS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER MANUFACTURER¿S LENS. PATIENT IS DOING WELL. NO FURTHER INFORMATION PROVIDED.

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

  MAUDE report 9846329 ↗
• InjuryJul 24, 2019Failure to Eject; Failure to Eject

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WOULD NOT COME OUT OF THE CARTRIDGE. THERE WAS PATIENT CONTACT. REPORTEDLY, SUTURES AND A VITRECTOMY WERE REQUIRED. THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Vitrectomy

  MAUDE report 8820179 ↗
• InjuryJul 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD BLURRY VISION SINCE DAY OF SURGERY. THEREFORE, EXPLANTED THE LENS AND EXCHANGED FOR A DIFFERENT MODEL BUT SAME DIOPTER LENS. THE EXPLANTED LENS WAS DISCARDED. REPORTEDLY, A VITRECTOMY WAS PERFORMED. THERE WAS NO PATIENT INJURY REPORTED. POST-EXCHANGE THE PATIENT STATES VISION IS IMPROVED AND MUCH CLEARER. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Blurred Vision; No Code Available; Vitrectomy

  MAUDE report 8769792 ↗
• InjuryMay 1, 2019Adverse 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/EXCHANGE DUE TO THE PATIENT BEING UNABLE TO TOLERATE. THE GOAL WAS PLANO, BUT THE RESULT WAS +4.5. THE REPLACEMENT LENS USED WAS THE SAME MODEL, DIOPTER SIZE NOT PROVIDED. THERE WAS AN INCISION ENLARGEMENT, BUT NO SUTURES WERE USED, AND THERE WAS THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8567675 ↗
• InjuryNov 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR NOTICED A LITTLE BIT OF BLOOD IN THE PATIENT'S OPERATIVE EYE, AND THEN WHEN A ZA9003 +16.5 DIOPTER INTRAOCULAR LENS WAS BEING IMPLANTED, THE DOCTOR ENCOUNTERED MORE BLOOD. THEREFORE, THE LENS WAS REMOVED, AN ANTERIOR VITRECTOMY WAS PERFORMED AND SUTURES WERE USED. THE PATIENT WENT HOME APHAKIC AND WILL BE REFERRED TO A RETINA SPECIALIST. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 8027776 ↗
• MalfunctionAug 28, 2018Scratched Material; Scratched Material

  IT WAS REPORTED THAT ZA900 INTRAOCULAR LENS (IOL) ''SPOILED'' OR MARKED IN A MANNER THAT WAS NOT IMPLANTABLE. THE ALLEGED ISSUE WAS NOTICED DURING HANDLING, BUT PRIOR TO INSERTION INTO THE EYE. IOL IS NOT USED AS THERE WAS NO PATIENT INVOLVEMENT AND/OR INJURY REPORTED. PRODUCT WILL BE RETURNED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7822964 ↗
• InjuryDec 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZA9003 16.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE LEFT EYE (OS) 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 LENS IMPLANTS. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE PATIENT'S LEFT EYE. A SEPARATE REPORT WILL BE FILED FOR THE RIGHT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 7111582 ↗
• MalfunctionNov 6, 2017Break; Break

  IT WAS REPORTED THAT THE HAPTIC BROKE OFF OF A ZA9003 16.5 DIOPTER INTRAOCULAR LENS (IOL) DURING THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT AND THE LENS HAD CONTACT WITH THE PATIENT'S EYE. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7004005 ↗
• InjuryAug 1, 2017Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING IMPLANTATION OF A ZA9003 16.5 DIOPTER INTRAOCULAR LENS (IOL) THE PHYSICIAN EXPERIENCED LOADING ISSUES. THE PHYSICIAN WAS UNABLE TO LOAD THE IOL ON DEPLOYMENT. INCISION ENLARGEMENT AND VITRECTOMY WERE REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 6758359 ↗
• InjuryAug 26, 2016Adverse 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 DUE TO MYOPIA. THERE WAS NO POST OP PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 5905688 ↗