TECNIS IOL ZA9003 (REF ZA90030140)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 05050474528895), received between Nov 28, 2017 and Dec 27, 2023 — classified as 6 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (9 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2023Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF THE NON PRELOADED MONOFOCAL LENS WAS BENT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18399107 ↗
• MalfunctionNov 27, 2023Break; Break

  IT WAS REPORTED THAT THE DOCTOR INSERTED THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) AND WHEN HE WAS TRYING TO PUT THE LENS IN THE CENTER OF THE PATIENT¿S RIGHT EYE, IT BROKE. SAME THING HAPPENED TO THE SECOND IOL OF THE SAME MODEL THAT WAS OPENED. IT WAS CONFIRMED THAT THE LENSES WERE NOT BROKEN WHEN THEY WERE OPENED AND THAT THE DOCTOR INDICATED WHEN HE USED THEM, THEY BROKE. IN BOTH CASES, IT IS UNKNOWN WHICH PART OF THE LENS (OPTIC OR HAPTICS) WAS BROKEN AS THE DOCTOR DID NOT SPECIFY. THE TWO LENSES WERE INSERTED AND REMOVED, BUT THE ORDER OF INSERTION AS TO WHICH LENS/SERIAL NUMBER INSERTED FIRST AND WHICH SECOND IS UNKNOWN. A THIRD JOHNSON & JOHNSON LENS OF 13.5 DIOPTER WAS FINALLY IMPLANTED IN THE PATIENT¿S EYE, BUT THE MODEL WAS NOT PROVIDED. NO INTERVENTIONS REQUIRED AND NO PATIENT INJURY REPORTED. THE REPORTER THINKS THE PATIENT WAS FINE AS THE DOCTOR DID NOT MENTION ANY COMPLICATIONS. BOTH LENSES WERE DISCARDED AFTER THE CASE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT PERTAINS TO THE LENS WITH SN (B)(6). A SEPARATE REPORT WILL BE SUBMITTED FOR THE EVENT WITH THE OTHER LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18212042 ↗
• MalfunctionNov 27, 2023Break; Break

  IT WAS REPORTED THAT THE DOCTOR INSERTED THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) AND WHEN HE WAS TRYING TO PUT THE LENS IN THE CENTER OF THE PATIENT¿S RIGHT EYE, IT BROKE. SAME THING HAPPENED TO THE SECOND IOL OF THE SAME MODEL THAT WAS OPENED. IT WAS CONFIRMED THAT THE LENSES WERE NOT BROKEN WHEN THEY WERE OPENED AND THAT THE DOCTOR INDICATED WHEN HE USED THEM, THEY BROKE. IN BOTH CASES, IT IS UNKNOWN WHICH PART OF THE LENS (OPTIC OR HAPTICS) WAS BROKEN AS THE DOCTOR DID NOT SPECIFY. THE TWO LENSES WERE INSERTED AND REMOVED, BUT THE ORDER OF INSERTION AS TO WHICH LENS/SERIAL NUMBER INSERTED FIRST AND WHICH SECOND IS UNKNOWN. A THIRD JOHNSON & JOHNSON LENS OF 13.5 DIOPTER WAS FINALLY IMPLANTED IN THE PATIENT¿S EYE, BUT THE MODEL WAS NOT PROVIDED. NO INTERVENTIONS REQUIRED AND NO PATIENT INJURY REPORTED. THE REPORTER THINKS THE PATIENT WAS FINE AS THE DOCTOR DID NOT MENTION ANY COMPLICATIONS. BOTH LENSES WERE DISCARDED AFTER THE CASE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT PERTAINS TO THE LENS WITH SN (B)(6). A SEPARATE REPORT WILL BE SUBMITTED FOR THE EVENT WITH THE OTHER LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18212013 ↗
• MalfunctionAug 8, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHEN IMPLANTING THE INTRAOCULAR LENS (IOL), THE TRAILING HAPTIC BROKE JUST BEFORE ENTERING THE PATIENT'S OPERATIVE EYE. ACCOUNT INDICATED THAT THE HAPTIC WAS SHOWING WHILST ADVANCING AND WHEN THE SURGEON ADVANCED THE LAST HAPTIC OUT, IT BROKE. THEREFORE, THE IOL WAS NOT IMPLANTED FULLY. THE LENS WAS REMOVED AND THERE WERE NO COMPLICATIONS REPORTED. THE PATIENT HAS FULLY RECOVERED AND WAS REPORTEDLY DOING FINE. THROUGH FOLLOW UP WE CONFIRMED THAT THE HAPTIC WAS COMPLETELY DETACHED AND NO SURGICAL INVENTIONS WERE REQUIRED. THE MATERIAL WAS DISCARDED AFTERWARDS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17484826 ↗
• MalfunctionJun 30, 2023Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO THE IOL BEING DAMAGED. IT WAS ALSO NOTED THAT THERE WAS A LOADING ERROR. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17242680 ↗
• InjuryOct 20, 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) FROM THEIR LEFT EYE. ANOTHER JOHNSON AND JOHNSON LENS (MODEL ZA9003, +12.5 DIOPTER) WAS PLACED AS THE REPLACEMENT IOL. NO VITRECTOMY OR SUTURES WERE REQUIRED. THE PATIENT IS STATED TO BE FULLY RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Discomfort; Eye Injury

  MAUDE report 15642242 ↗
• InjuryJul 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD TO BE REMOVED FROM PATIENT'S OPERATIVE EYE, AS IT WAS UNABLE TO LEAVE IMPLANTED DUE TO PATIENT HISTORY. ADDITIONAL INFORMATION RECEIVED REVEALED THAT THE LENS WAS ACTUALLY EXPLANTED IN A SECONDARY PROCEDURE AND NO REPLACEMENT LENS WAS USED. IT WAS INDICATED THAT THERE WAS NO PRODUCT QUALITY ISSUE WITH THE ORIGINAL LENS AND THAT THERE WAS NO USE ERROR THAT LED TO THE EVENT. THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTION WAS REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 15061461 ↗
• InjuryMar 29, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS DISLOCATED POST IMPLANTATION IN THE LEFT EYE. THROUGH FOLLOW-UP, THE CUSTOMER CLARIFIED THAT THE ACTUAL CAUSE OF SUBLUXATION WAS PSEUDOEXFOLIATION WITH ZONULAR LOSS. THE LENS MOVED ON ITS OWN SPONTANEOUSLY. THE SURGEON EXPLANTED THE LENS DURING SECONDARY SURGERY AND REPLACED WITH ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) WITH SCLERAL FIXATION. 1 DAY POST-OPERATIVE (OP) EXAM SHOWED BLURRED VISUAL ACUITY (VA) DUE TO CIRCULATING HYPHEMA. VISION ACUITY PRE-OP IS 20/30, POST OP IS UNKNOWN. THERE IS NO TRAUMA TO THE EYE. THE PATIENT RECEIVED PRESCRIPTIVE MEDICATION; HOWEVER, DETAILS NOT PROVIDED. THE PATIENT CURRENT STATUS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. A SEPARATE REPORT IS BEING SUBMITTED FOR THE REPLACEMENT LENS REPORTED EVENT.

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

  MAUDE report 13944760 ↗
• InjuryJan 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE DUE TO DISLOCATION OF THE IOL. PATIENT PRESENTED WITH ONSET OF BLURRY VISION. A PARS PLANA VITRECTOMY, GONIOTOMY YAMANE INTRASCLERAL HAPTIC FIXATION OF THE IOL, AND LIMBAL RELAXATION INCISIONS WERE PERFORMED. A NON-JOHNSON & JOHNSON LENS, 14.0 DIOPTER WAS USED AS A REPLACEMENT. PATIENT'S OUTCOME WAS GOOD, AND NO INJURY WAS REPORTED. IT WAS INDICATED THAT THE LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 13198454 ↗
• MalfunctionDec 9, 2021Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD THE HAPTIC VISIBLY BROKEN. WAS SEEN AFTER/DURING IOL INSERTION. NOTED THEN TO HAVE PATIENT CONTACT WITH THE IOL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12973277 ↗
• MalfunctionSep 9, 2021Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT A TECNIS INTRAOCULAR LENS (IOL) HAPTIC WAS BENT/BROKEN WHILE INSERTING INTO THE PATIENT'S RIGHT (OD) EYE. THE LENS WAS REMOVED AND THE PATIENT HAS RECOVERED. THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12449384 ↗
• InjuryJul 30, 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 THE PATIENT EXPERIENCING VISUAL DISTURBANCES. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. SURGERY WAS COMPLETED WITH A NON-JOHNSON & JOHNSON REPLACEMENT LENS. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 12251511 ↗
• MalfunctionJul 6, 2021Break; Break

  FULLY INSERTED LENS WAS REMOVED AND REPLACED IN THE SAME PROCEDURE DUE TO THE TRAILING HAPTIC BEING BENT. UNABLE TO ROTATE POSITION LENS WITH BENT HAPTIC. PHYSICIAN PUT IN NEW (SAME MODEL) LENS AND CUT DAMAGED LENS OUT. REMOVED LENS IN 2 PIECES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12125380 ↗
• MalfunctionJan 3, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TRAILING HAPTIC OF A ZA9003 14.0 DIOPTER INTRAOCULAR LENS (IOL) WAS BENT. THE LENS WAS INSERTED AND REMOVED FROM THE EYE DURING THE SAME PROCEDURE. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS THE SAME MODEL AND DIOPTER. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. THE ACCOUNT COMMENTED THAT THEY BELIEVE THE EVENT OCCURRED DUE TO A USER/TECHNICIAN ERROR. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8212234 ↗
• MalfunctionOct 18, 2018Break; Break

  IT WAS REPORTED THAT TECNIS MONOFOCAL INTRAOCULAR LENS (MODEL ZA9003 +14.0 DIOPTER) HAD DEFECTIVE HAPTIC. THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7982563 ↗
• MalfunctionJun 26, 2018Break; Crack; Break; Crack

  IT WAS REPORTED THAT BROKEN HAPTICS AND CRACKED INTRAOCULAR LENS (MODEL ZA9003) WERE NOTICED WHEN THE LENS WAS ABOUT TO BE REMOVED FROM THE PACKAGE. NO PATIENT CONTACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7637308 ↗
• InjuryNov 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE INCISION HAD TO BE ENLARGED AND THE LENS HAD TO BE REMOVED FROM THE EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7066001 ↗