TECNIS IOL ZA9003 (REF ZA90030205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 05050474529021), received between Oct 7, 2016 and Jun 9, 2025 — classified as 39 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Break” (33 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 86 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THE LENS WAS PARTIALLY DELIVERED IN THE PATIENT'S LEFT EYE AND THEN REMOVED. REMOVAL AND REPLACEMENT HAPPENED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER). AN INCISION ENLARGEMENT AND A VITRECTOMY WERE REQUIRED; HOWEVER, A SUTURE WAS NOT REQUIRED. THERE WAS NO OTHER MEDICAL OR SURGICAL INTERVENTION. THE PATIENT IS DOING FINE POST-OPERATIVELY. THROUGH FOLLOW UP, IT WAS CLARIFIED THAT THE SURGEON STATED THE LENS LOADED CORRECTLY, BUT THE SURGEON COULD NOT FULLY ADVANCE IT INTO THE PATIENT'S EYE. THE LENS WAS PARTIALLY INSERTED AND THE SURGEON STARTED TO MANIPULATE THE LENS WITH THE CHOPPER AND IT SOMEHOW INTERFERED WITH THE LEADING HAPTIC. AT THIS POINT, THE PATIENT'S EYE BECAME UNSTABLE REQUIRING AN INCISION ENLARGEMENT AND AN UNPLANNED VITRECTOMY WAS PERFORMED. THE LENS IS NOT AVAILABLE AS IT WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear

  MAUDE report 22172551 ↗
• MalfunctionDec 13, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20928336 ↗
• MalfunctionAug 28, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE NON PRELOADED INTRAOCULAR LENS (IOL) WOULD NOT SIT CORRECTLY. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT THE EVENT OCCURRED DURING SURGERY. THE LENS WAS INSERTED AND REMOVED IN THE SAME PROCEDURE. THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL/ SURGICAL INTERVENTION REQUIRED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20089410 ↗
• MalfunctionJul 23, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THERE WAS DEFECT AND MARK ON LENS WHEN IT WAS IMPLANTED INTO PATIENT'S EYE. THERE WAS INSERTION OF LENS INTO THE PATIENT'S EYE AND IT WAS THEN REMOVED WHEN THE SURGEON NOTICED THE SCRATCHES. REPLACEMENT LENS WAS USED. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19811449 ↗
• InjuryNov 29, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE NON PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) LENS WAS NOT SITTING RIGHT. DOCTOR WAS ABLE TO REMOVE THE INSERTED IOL. A DIFFERENT LENS OF THE SAME MODEL WAS USED WITHOUT ANY ISSUES DURING SAME PROCEDURE. THE PATIENT'S POST-PROCEDURE STATUS IS GOOD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18233943 ↗
• MalfunctionAug 10, 2023Break; Break

  IT WAS REPORTED THAT THE MONOFOCAL NON PRELOADED INTRAOCULAR LENS HAPTIC WAS BENT. THERE WAS NO PATIENT INJURY. SURGEON IMPLANTED LENS FROM ANOTHER MANUFACTURER. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17500548 ↗
• MalfunctionAug 10, 2023Break; Break

  IT WAS REPORTED THAT THE MONOFOCAL NON PRELOADED INTRAOCULAR LENS HAPTIC WAS BENT. THERE WAS NO PATIENT INJURY. SURGEON IMPLANTED LENS FROM ANOTHER MANUFACTURER. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17500532 ↗
• InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING THE SURGERY, THERE WAS SO MUCH ZONULAR LOSS IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE), THE CAPSULAR TENSION RING DID NOT HOLD. BOTH THE CAPSULAR TENSION RING (CTR) AND THE INTRAOCULAR LENS (IOL) HAD TO BE REMOVED; A REPLACEMENT IOL WAS NOT IMPLANTED. A VITRECTOMY WAS PERFORMED AND 10-0 SUTURE WAS PLACED, HOWEVER, THERE WAS NO PATIENT INJURY. IT WAS NOT CONFIRMED IF ZONULAR LOSS WAS DUE TO A PATIENT ANATOMY ISSUE OR IF IT WAS DUE TO A PRODUCT QUALITY ISSUE. PATIENT WILL RETURN AT LATER DATE FOR IOL PLACEMENT WHEN SURGEON DEEMS NECESSARY AND WHEN THE PATIENT HAS HEALED FROM SUTURE PLACEMENT. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS GOOD. THE REMOVED IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Zonular Dehiscence

  MAUDE report 17455502 ↗
• MalfunctionJul 21, 2023Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAS THE HAPTIC KINKED IN CARTRIDGE WHEN LOADING AND NOTICED UPON INSERTION. THE IOL WAS PARTIALLY DELIVERED IN PATIENT'S RIGHT EYE. INCISION WAS ENLARGED PRIOR TO LENS INSERTION, ANTERIOR VITRECTOMY WAS PERFORMED. UNKNOWN IF THERE WAS PATIENT POST-OP INJURY OR NOT. SURGERY WAS SUCCESSFULLY COMPLETED USING THE BACK-UP LENS WITH THE SAME MODEL IOL AND SAME DIOPTER POWER SIZE IOL. THE SUSPECT PRODUCT WAS DISCARDED ON SITE DAY OF SURGERY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17372465 ↗
• MalfunctionJul 19, 2023Difficult to Fold, Unfold or Collapse; Material Fragmentation; Mechanical Jam; Difficult to Fold, Unfold or Collapse; Material Fragmentation; Mechanical Jam

  IT WAS REPORTED THAT THE LEADING HAPTIC OF THE INTRAOCULAR LENS (IOL) WAS STUCK IN THE CARTRIDGE AND WAS FOUND FOLDED AFTER INSERTION. WHILE MANIPULATING THE IOL, THE HAPTIC WAS DETACHED FROM THE IOL OPTIC AND REMOVED FROM THE PATIENT'S EYE. THERE WAS NO DELAY IN TREATMENT OR OTHER INTERVENTIONS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17352976 ↗
• InjuryJul 11, 2023Adverse 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 THE RIGHT EYE IN A SECONDARY PROCEDURE DUE TO HALOS AROUND LIGHTS THAT WAS WORSE AT NIGHT. THE ISSUE WAS IDENTIFIED DURING A POST-OPERATIVE EXAM. A NON-JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIFFERENT DIOPTER OF + 20.0). NO INCISION ENLARGEMENT OR VITRECTOMY WAS REQUIRED. THERE WAS NO DELAY IN PROCEDURE. DIRECTIONS FOR USE WERE FOLLOWED. THE PATIENT IS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo

  MAUDE report 17302750 ↗
• MalfunctionJul 4, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE DUE TO MISSING/DETACHED HAPTIC. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17253634 ↗
• MalfunctionJul 3, 2023Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE DUE TO BENT/BROKEN/KINKED HAPTIC. THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17245223 ↗
• MalfunctionJun 9, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE, THE SURFACE WAS FOUND TO BE CREASED. THE IOL WAS REMOVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17101842 ↗
• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON DAY 1 POST INTRAOCULAR LENS (IOL) IMPLANTATION INTO THEIR RIGHT EYE, THE PATIENT WAS RE-EXAMINED, AND THE VISUAL ACUITY WAS 0.6, AND THERE WAS CORNEAL EDEMA. THE IOL POSITION WAS POSITIVE, AND THE INTRAOCULAR PRESSURE WAS 10.8 MMHG. THE PATIENT WAS GIVEN TOBRAMYCIN DEXAMETHASONE EYE DROPS 0.02 ML TO BE APPLIED ONCE AN HOUR IN THE RIGHT EYE. THE NEXT DAY, VISUAL ACUITY OF 0.6 WAS NOTED IN THE RIGHT EYE WITH MILD CORNEAL DETUMESCENCE. THE PATIENT WAS INSTRUCTED TO CONTINUE USING TOBRAMYCIN AND DEXAMETHASONE OPHTHALMIC SOLUTION 0.02ML IVGTT 6 TIMES/DAY IN THE RIGHT EYE. THE PATIENT IS BEING MONITORED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Corneal Edema

  MAUDE report 16748261 ↗
• MalfunctionMar 20, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS CRACKED /TORN. IT WAS A NON PRELOADED IOL BUT INFORMATION PROVIDED CANNOT CONFIRM IF WITH PATIENT CONTACT OR NOT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16576950 ↗
• MalfunctionMar 16, 2023Break; Break

  IT WAS REPORTED THAT THE HAPTICS OF THE NON-PRELOADED INTRAOCULAR LENS (IOL) WERE CLOSE TO THE LENS AND NOT ¿SPREAD¿ OUT. THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16560499 ↗
• MalfunctionFeb 23, 2023Break; Break

  IT WAS REPORTED THAT THE ZA9003 LENS LEAD HAPTIC WAS BENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16433302 ↗
• InjuryFeb 20, 2023Adverse 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 OPERATIVE EYE. PATIENT HAS DECREASED VISION AND THEIR EYES ARE WORKING TOO HARD. THE PATIENT HAS DOUBLE VISION AND PAIN SINCE SURGERY. FIRST IDENTIFIED IN POST-OPERATIVE (OP) VISIT. SYMPTOMS PERSISTED FOR 5 MONTHS. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND 19.5 DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THE PATIENT FULLY RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort; Eye Pain; Visual Impairment

  MAUDE report 16402066 ↗
• MalfunctionFeb 16, 2023Contamination; Contamination

  IT WAS REPORTED THAT ONCE THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED, IT WAS NOTICED THAT DEBRIS WAS STUCK ON THE LENS. THE SURGICAL TECH DID NOT SEE THE ISSUE UNTIL IT WAS INSERTED IN THE EYE AND UNDER THE MICROSCOPE. IT APPEARED THAT "SOMETHING WAS STUCK TO OR ON THE LENS". THE LENS WAS THEN REMOVED AND REPLACED IN THE SAME PROCEDURE. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED SUCCESSFULLY AS REPLACEMENT (SAME MODEL AND DIOPTER). NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED AND THERE WAS NO PATIENT INJURY. THE PATIENT IS DOING WELL POST-OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16387096 ↗
• MalfunctionFeb 14, 2023Break; Break

  IT WAS REPORTED THE ZA9003 INTRAOCULAR LENS (IOL) TRAILING HAPTIC BROKE AND THERE WAS PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16373130 ↗
• MalfunctionJan 31, 2023Break; Break

  RECEIVE REPORT OF A TRAILING HAPTIC THAT WAS BENT. IT WAS NOTICED DURING IMPLANTATION. THE CUSTOMER EXPLAINED THAT THE IOL COMES SO CLOSE TO THE EYE THAT THEY REPORT IT AS HAVING CONTACT JUST TO BE SAFE. THERE WERE NO COMPLICATIONS SUCH AS CAPSULE TEAR, VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. THE PROCEDURE WAS COMPLETED WITH A BACKUP LENS. AT THE TIME OF THIS REPORT THEY INDICATED IT¿S UNKNOWN IF IT¿S THE SAME MODEL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16275344 ↗
• InjuryJan 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE J&J IOL (INTRAOCULAR LENS) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO THEM EXPERIENCING DYSPHOTOPSIA. IT WAS UNKNOWN IF THEIR DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES REQUIRED. REPORTEDLY, AFTER THE EXPLANT THE PATIENT FULLY RECOVERED. NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 16200781 ↗
• MalfunctionDec 13, 2022Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED IN PATIENT'S RIGHT EYE, PINCHED TRAILING HAPTIC. NO REPORT OF OTHER ADVERSE EVENTS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15973910 ↗
• MalfunctionNov 30, 2022Break; Break

  REPORT OF INTRAOCULAR LENS (IOL) WHEN INSERTING PARTIALLY INSERTED, HAPTIC WAS BENT, USED BACK-UP IOL TO COMPLETE. THERE WAS NO PATIENT INJURY, PATIENT DOING FINE. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15891600 ↗