TECNIS IOL ZA9003 (REF ZA90030160)Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 05050474528932), received between May 25, 2017 and Jan 10, 2025 — classified as 16 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 30 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NON-PRELOADED MONOFOCAL LENS WAS EXPLANTED DUE TO VISUAL DISTURBANCES TWO MONTHS AFTER IMPLANTATION. THE LENS WAS REMOVED AND REPLACED DURING A SECONDARY SURGICAL PROCEDURE WITH A NON-JOHNSON & JOHNSON (J&J) INTRAOCULAR LENS (IOL). THE PATIENT FULLY RECOVERED, AND THERE WERE NO UNPLANNED INCISIONS, SUTURES, OR VITRECTOMY INVOLVED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 21127818 ↗
• MalfunctionDec 27, 2023Break; Break

  IT WAS REPORTED THAT THE NON PRELOADED MONOFOCAL INTRAOCULAR LENS WAS PARTIALLY INSERTED, REMOVED AND REPLACED IN THE SAME PROCEDURE DUE TO SPLIT IN THE HAPTIC. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER LENS OF SAME MODEL. THERE WAS NO PATIENT INJURY. NO OTHER MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED. PATIENT¿S OUTCOME WAS FINE. BASED ON THE ADDITIONAL INFORMATION RECEIVED THE HAPTIC WAS SPLIT LENGTHWISE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18399818 ↗
• MalfunctionDec 10, 2023Break; Break

  IT WAS INITIALLY REPORTED THAT THE MONOFOCAL INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED AND IT WAS DISCOVERED THAT THE HAPTIC WAS BENT. IT WAS INDICATED THAT THE HAPTIC WAS BENT PRIOR TO INSERTION, AND WHEN THEY LOADED THE LENS. WHEN THE IOL WAS INSERTED IT WAS NOTICED THAT IT HAD A BENT HAPTIC SO THE DOCTOR STOPPED THE INSERTION OF THE LENS. NO USE ERROR WAS INDICATED. THE CUSTOMER CONTACT PERSON INDICATED THAT THE CARTRIDGE DEFINITELY CAME IN CONTACT WITH THE EYE AND POSSIBLY THE HAPTIC TOO WHICH THEY DOCTOR MUST HAVE NOTED THE DAMAGE, BUT THE CONTACT WAS NOT SURE IF THE LENS/HAPTIC HAD PATIENT CONTACT OR NOT. ANOTHER LENS OF THE SAME MODEL AND DIOPTER WAS USED AS A REPLACEMENT. THERE WAS NO CAPSULE TEAR, NO SURGICAL OR MEDICAL INTERVENTIONS REQUIRED. THE PATIENT OUTCOME WAS FINE, AND NO INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18298381 ↗
• MalfunctionSep 7, 2023Material Fragmentation; Use of Device Problem; Material Fragmentation; Use of Device Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS NOT IMPLANTED. THE DOCTOR THINKS HE COULD HAVE MESSED IT UP TRYING TO LOAD, BUT THERE WAS NO LOADING HAPTIC WHEN THE DOCTOR WENT TO INSERT THE LENS; THEREFORE, THEY GOT A NEW LENS. IT IS UNKNOWN IF THERE WAS PATIENT CONTACT WITH THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17706188 ↗
• InjuryAug 11, 2023Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE) WHEN THE HAPTIC BENT. THE SAME PROCEDURE WAS COMPLETED USING BACK-UP ZA9003 16.0 DIOPTER IOL. THE INCISION WAS ENLARGED PRIOR TO INSERTION OF LENS, SUTURE(S) WERE REQUIRED, AND AN ANTERIOR VITRECTOMY WAS PERFORMED HOWEVER, THERE WAS NO SERIOUS PATIENT INJURY. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS NORMAL. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 17515981 ↗
• MalfunctionJul 13, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) BROKE DURING THE OPERATION AND BECAME UNSTERILE. ACCOUNT HAS INDICATED THAT PRESUMABLY THE LENS BROKE DURING PREPARATION. AFTER IMPLANTATION OF THE LENS, THE SURGEON NOTICED THAT ONE HAPTIC WAS TORN OFF. THEREFORE, THE IOL WAS EXPLANTED AND REPLACED WITH ANOTHER LENS OF THE SAME MODEL. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17322338 ↗
• InjuryMay 26, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO FAILED IOL. IT WAS REPLACED WITH THE SAME MODEL AND DIOPTER SIZE IOL. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. NO PATIENT INJURY. A DIFFERENT DOCTOR IMPLANTED THE IOL FROM THE DOCTOR WHO EXPLANTED IT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 17008426 ↗
• 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 LEFT EYE, THE PATIENT WAS RE-EXAMINED, AND THE VISUAL ACUITY WAS 0.12, AND THERE WAS CORNEAL EDEMA. THE IOL POSITION WAS POSITIVE, AND THE INTRAOCULAR PRESSURE WAS 6.1 MMHG. THE PATIENT WAS GIVEN LEVOFLOXACIN EYE DROPS 0.02ML AND TOBRAMYCIN AND DEXAMETHASONE EYE DROPS 0.02ML. THE NEXT DAY, VISUAL ACUITY OF 0.25 WAS NOTED IN THE LEFT EYE WITH CORNEAL EDEMA. ACCOUNT PROVIDED THAT THE CONDITION IS GETTING BETTER. THE PATIENT WAS ASKED TO CONTINUE THE SAME MEDICATION AS BEFORE, AND SWITCHED TO 6 TIMES/DAY AT 3 TIMES. THE PATIENT IS BEING MONITORED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Corneal Edema; Inflammation

  MAUDE report 16748242 ↗
• InjurySep 29, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FOR AN UNSPECIFIED REASON. THE LENS WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE REASON THE LENS WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE WAS DUE TO LENS DISLOCATION. A NEW LENS WAS IMPLANTED, HOWEVER, THE REPLACEMENT LENS INFORMATION WAS NOT AVAILABLE. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY. THE PATIENT OUTCOME WAS UNAVAILABLE. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 15507189 ↗
• MalfunctionSep 12, 2022Break; Break

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS PARTIALLY INSERTED AND REMOVED FROM THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) DUE TO BENT HAPTIC. IT WAS CONFIRMED THE LENS WAS NOT STUCK IN THE CARTRIDGE. THERE WAS NO MEDICAL INTERVENTION, NO SURGICAL INTERVENTION, AND NO PATIENT INJURY. A NON-JOHNSON & JOHNSON IOL WAS USED TO COMPLETE THE PROCEDURE. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS DOING FINE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15407412 ↗
• InjurySep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REQUIRED AN EXPLANT OF THE INTRAOCULAR LENS (IOL) DUE TO REFRACTIVE SURPRISE. ACCOUNT INDICATED THAT NO VITRECTOMY WAS REQUIRED AND NO MEDICATION WAS PRESCRIBED. THE PATIENT IS STATED TO BE FULLY RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 15381166 ↗
• InjuryAug 11, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD TO BE REMOVED FROM A PATIENT'S LEFT EYE AS THE HAPTIC KINKED. THERE WAS NO PATIENT INJURY AND ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. TWO SUTURES WERE PLACED AND THE PATIENT IS DOING FINE POST-OPERATION. THE ORIGINAL LENS WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15215068 ↗
• InjuryAug 2, 2022Adverse 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, REASON FOR EXPLANT NOT PROVIDED. SCLERAL FIXATION WAS PERFORMED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 15153934 ↗
• MalfunctionJul 13, 2022Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15008306 ↗
• InjuryApr 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF HAVING BLURRY VISION AND CANNOT SEE OUT OF THE EYE. THE INTRAOCULAR LENS (IOL) WAS ORIGINALLY IMPLANTED IN THE PATIENT'S OPERATIVE EYE IN (B)(6) 2009. UPON EXAMINATION, THE IOL WAS FOUND TO BE DISLOCATED. THE SURGEON EXPLANTED THE LENS ON (B)(6) 2022 AND STEROID/ANTIBIOTIC WAS PRESCRIBED POST SURGERY. THE PATIENT HAS REPORTEDLY FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 14121081 ↗
• MalfunctionJan 27, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE HAPTIC OF THE INTRAOCULAR LENS (IOL) BROKE OFF. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13372969 ↗
• MalfunctionOct 20, 2021Break; Break

  IT WAS REPORTED THE DOCTOR HAD PLANNED TO SUTURE IN THE INTRAOCULAR LENS (IOL), WHILE TRYING TO MANEUVER THE HAPTICS EXACTLY WHERE HE NEEDED IT, A HAPTIC BROKE. DOCTOR REMOVED THE LENS AND HAPTIC FROM THE PATIENT'S OCULAR DEXTER (RIGHT EYE) AND DECIDED TO PLACE A NON-JOHNSON & JOHNSON SURGICAL VISION ANTERIOR LENS BECAUSE HE DID NOT WANT TO CHANCE AN INJURY BY PLACING ANOTHER 3-PIECE LENS. THE PATIENT DID WELL WITH THE SURGERY AND NO COMPLICATIONS WERE REPORTED. THE SURGERY WENT AS PLANNED THEREAFTER AND THE PATIENT IS DOING WELL. THE LENS WAS DISCARDED AND IS NOT BEING RETURNED. ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING NO PATIENT INJURY. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THE IOL WAS FULLY INSERTED WHEN THE HAPTIC BROKE, BUT THE DOCTOR WAS ABLE TO REMOVE ALL THE PIECES. THERE WAS NO UNPLANNED INCISION ENLARGEMENT. SINCE IT WAS A RETINA CASE, THEY WERE ALREADY DOING A VITRECTOMY, BUT DIDN¿T HAVE TO DO ANYTHING EXTRA DUE TO THE BROKEN HAPTIC. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12666677 ↗
• MalfunctionJul 9, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AFTER IMPLANTATION OF THE INTRAOCULAR LENS (IOL), THE SURGEON NOTICED THAT THE LENS HAPTIC WAS DETACHED. HE HAD TO REMOVE THE LENS AND IMPLANT A NEW ONE. NO PATIENT INJURY WAS REPORTED. THE MATERIAL IS NOT AVAILABLE FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12147590 ↗
• InjuryJun 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED REPORT INDICATING THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE BECAUSE THE IOL WAS INCOMPATIBLE AS THE PATIENT EXPERIENCED BLURRY VISION. AT EXPLANT THE INCISION WAS ENLARGED AND THE REPLACEMENT LENS WAS A NON-JOHNSON & JOHNSON IOL. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS FINE POST-EXCHANGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 11971380 ↗
• InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT RIGHT EYE DUE TO PATIENT DESIRED DIFFERENT REFRACTIVE OUTCOME. THERE WAS NO ADDITIONAL SURGICAL/MEDICAL INTERVENTION REQUIRED. THE LENS WAS REPLACED BY TFAT00 16.5 DIOPTER LENS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 11009061 ↗
• InjuryNov 3, 2020Break; Break

  IT WAS REPORTED THAT THE HAPTIC WAS BROKEN. THE ISSUE WAS OBSERVED AFTER THE LENS WAS FULLY IMPLANTED AND WAS THEN REMOVED AND REPLACED. THERE WAS NO DELAY IN THE PROCEDURE AND NO MEDICATION WAS PRESCRIBED. THROUGH FOLLOW-UP IT WAS LEARNED THAT THE INCISION WAS ENLARGED FROM 2.2 TO 2.8. PATIENT OUTCOME WAS GOOD AFTER REPLACEMENT WITH ANOTHER LENS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10782569 ↗
• 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 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 9846388 ↗
• InjuryJul 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZA9003 16.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) AND REMOVED AS THE PATIENT¿S EYE WAS UNSTABLE. IT WAS REPORTED THERE WAS A VITRECTOMY, INCISION ENLARGEMENT WAS REQUIRED, OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE, AND THE PATIENT HAS RECOVERED. ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER ACCOUNT REQUESTING ADDITIONAL INFORMATION HOWEVER, TO DATE NO RESPONSE HAS BEEN RECEIVED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 8816331 ↗
• MalfunctionMar 26, 2019Break; Break

  A PRODUCT BOX WAS RECEIVED WITH A NOTE THAT SAID ZA9003 INTRAOCULAR LENS (IOL) HAPTIC WAS BROKEN. IT WAS LEARNT THAT THE ACTUALLY LENS WAS NOT RETURNED ONLY THE PACKAGING WAS RECEIVED. DESPITE SEVERAL FOLLOW-UPS, NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 8454084 ↗
• MalfunctionNov 8, 2018Break; Break

  IT WAS REPORTED THAT WHEN INSERTING THE INTRAOCULAR LENS (IOL) ZA9003 INTO THE PATIENT'S OPERATIVE EYE, THE LENS HAD A BENT HAPTIC. NO MEDICAL INTERVENTION WAS REQUIRED. A REPLACEMENT LENS OF THE SAME MODEL AND DIOPTER WAS USED. ADDITIONAL INFORMATION RECEIVED STATED THAT THERE WAS NO PATIENT INJURY AND THE PATIENT WAS DOING FINE POST-OP. THE COMPLAINT IOL WAS DISCARDED BY THE CUSTOMER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8050136 ↗