TECNIS IOL ZA9003 (REF ZA90030215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 05050474529045), received between Sep 13, 2016 and Jul 10, 2026 — classified as 43 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Break” (37 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 25 most recent of 92 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN ISSUE OCCURRED DURING IMPLANTATION OF A STANDALONE INTRAOCULAR LENS (IOL), WHICH COULD NOT BE IMPLANTED DURING THE PROCEDURE. ADDITIONAL INFORMATION CLARIFIED THAT A CAPSULAR RUPTURE OCCURRED DURING IMPLANTATION. THE IOL WAS FULLY INSERTED INTO THE EYE; HOWEVER, IT BECAME UNSTABLE AND IT WAS REMOVED. AN ANTERIOR VITRECTOMY WAS REQUIRED, AND THE PATIENT WAS LEFT APHAKIC. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 25786683 ↗
• InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NON-PRELOADED MONOFOCAL INTRAOCULAR LENS WAS EXPLANTED FROM THE PATIENT'S EYE DURING SECONDARY SURGERY FOR AN UNSPECIFIED REASON. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 22709216 ↗
• MalfunctionJul 16, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS WAS PLACED AND REMOVED DURING THE SAME PROCEDURE AS THE LENS WOULDN¿T CENTER. LENS WAS FULLY INSERTED AND THE ISSUE HAPPENED AFTER IMPLANTATION. NO INCISION ENLARGEMENT. VITRECTOMY AND SUTURES WERE NOT REQUIRED. THERE WAS NO DELAY IN PROCEDURE. THE PATIENT WAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22521841 ↗
• MalfunctionMay 15, 2025Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22032573 ↗
• MalfunctionJan 27, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT AN MONOFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT RIGHT EYE DURING A SECONDARY SURGICAL PROCEDURE DUE TO BREAKDOWN (MECHANICAL) ISSUE OF THE IOL. THERE WERE NO UNPLANNED (VITRECTOMY, INCISION ENLARGEMENT OR SUTURES) REQUIRED. THE REPLACEMENT LENS WAS A NON-JOHNSON & JOHNSON LENS OF +21.25 DIOPTER. THE PATIENT OUTCOME WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21249127 ↗
• MalfunctionNov 11, 2024Break; Break

  IT WAS REPORTED THAT THE STANDALONE 3 PIECE MONOFOCAL INTRAOCULAR LENS (IOL) WAS BROKEN. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20658948 ↗
• MalfunctionNov 11, 2024Break; Break

  IT WAS REPORTED THAT THE STANDALONE 3 PIECE MONOFOCAL INTRAOCULAR LENS (IOL) WAS BROKEN. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20658505 ↗
• MalfunctionJul 3, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AN MONOFOCAL INTRAOCULAR LENS (IOL) WAS FULLY INSERTED AND REMOVED DURING THE SAME PROCEDURE DUE TO ONE OF THE HAPTICS BROKE OFF THE LENS. AN INCISION ENLARGEMENT AND SUTURES WERE REQUIRED, HOWEVER, A VITRECTOMY WAS NOT REQUIRED. THERE WAS NO DELAY IN PROCEDURE. NO MEDICATION WAS PRESCRIBED. DAILY ACTIVITIES WAS NOT SIGNIFICANTLY AFFECTED. THE PATIENT HAS FULLY RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 19672100 ↗
• MalfunctionJun 24, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A MONOFOCAL INTRAOCULAR LENS (IOL) HAD DIFFICULTY DEPLOYING, IT WAS AN UNFOLDING ISSUE. THE SURGEON REMOVED THE IOL FROM PATIENT'S OPERATIVE EYE AND REPLACED WITH A SECOND LENS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19601439 ↗
• MalfunctionJun 4, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT THE STANDALONE INTRAOCULAR LENS (IOL) WAS BENT. NO FURTHER DETAILS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19464471 ↗
• MalfunctionJun 4, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT THE STANDALONE INTRAOCULAR LENS (IOL) HAD A BENT HAPTIC. NO FURTHER DETAILS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19464460 ↗
• InjuryMar 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED. AND REMOVED, DURING THE SAME PROCEDURE, DUE TO A NEED FOR A VITRECTOMY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 18891567 ↗
• MalfunctionNov 28, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THE ZA9003 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) BUT DUE TO POOR CAPSULE SUPPORT THE IOL WOULD NOT STAY IN PATIENT'S EYE. THE IOL WAS REMOVED FROM THE PATIENT'S EYE AND THE PATIENT LEFT WITH NO LENS IN PLACE. THERE WAS NO PATIENT INJURY AND NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. PATIENT STATUS POST-PROCEDURE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 18221262 ↗
• MalfunctionOct 6, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT¿S EYE AND WAS REMOVED DURING THE SAME PROCEDURE DUE TO THE HAPTIC BROKE OFF. THE REPLACEMENT IOL WAS ANOTHER JNJ LENS WITH THE SAME MODEL. THERE WAS NO PATIENT ISSUES AND THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. PATIENT STATUS POST-PROCEDURE WAS REPORTED AS FINE. THE SUSPECT IOL IS AVAILABLE FOR RETURN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17887102 ↗
• MalfunctionSep 1, 2023Break; Failure to Fold; Break; Failure to Fold

  IT WAS REPORTED THAT THE TECNIS NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WOULD NOT FOLD AND HAPTIC WAS BROKE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17672385 ↗
• InjuryAug 25, 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 LEFT EYE DUE TO REFRACTIVE SURPRISE. THE INCISION WAS ENLARGED, BUT NO ADDITIONAL INTERVENTIONS INDICATED. THE PATIENT HAS FULLY RECOVERED AND NO INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 17627593 ↗
• MalfunctionAug 11, 2023Break; Break

  IT WAS REPORTED THAT TECNIS INTRAOCULAR LENS (IOL) WAS DEFECTIVE. HAPTIC WAS TORN UPON INSERTION OF LENS IN THE PATIENTS RIGHT EYE. UPON REALIZATION LENS WAS IMMEDIATELY REMOVED. NEW LENS WAS INSERTED SUCCESSFULLY. LENS WAS PARTIALLY INSERTED AND REMOVED DURING THE SAME PROCEDURE. THERE WAS NO UNPLANNED INCISION ENLARGEMENT, SUTURES, AND/OR VITRECTOMY NEEDED. THERE WAS 10 MINUTES DELAY IN PROCEDURE. DIRECTIONS FOR USE WERE FOLLOWED. ADDITIONAL INFORMATION RECEIVED STATED THAT SAME MODEL BACKUP LENS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO USE ERROR. NO PATIENT INJURY OR MEDICAL/SURGICAL INTERVENTION REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17515840 ↗
• InjuryJul 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) DISLOCATED POST IMPLANTATION. THE IOL WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE. AN UNPLANNED VITRECTOMY WAS REQUIRED. THE REPLACEMENT LENS IS THE SAME MODEL BUT A DIFFERENT DIOPTER, MODEL ZA9003 22.5 DIOPTER. REPORTEDLY, THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 17356500 ↗
• MalfunctionJun 19, 2023Break; Break

  IT WAS REPORTED THAT ZA9003 INTRAOCULAR LENS HAPTIC WAS BENT AND HAD PATIENT CONTACT. THE PATIENT WAS FINE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17159617 ↗
• MalfunctionJun 14, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON(JNJ) INTRAOCULAR LENS (IOL) MODEL ZCB00 A ONE-PIECE LENS WAS ON THE FIELD AND DID NOT HAVE PATIENT CONTACT. IT DID NOT COME NEAR THE PATIENT AND THERE WAS NOTHING WRONG WITH THE IOL. DOCTOR CONVERTED TO VITRECTOMY DURING PHACO AND SWITCHED TO ANOTHER LENS. THE PHACO MACHINE IS JNJ EQUIPMENT. IT¿S UNKNOWN IF THE CONVERSION TO VITRECTOMY WAS DUE TO EQUIPMENT MALFUNCTION OR USE ERROR. THE SECOND IOL THE DOCTOR USED IS MODEL ZA9003 21.5 DIOPTER WHICH IS A THREE-PIECE LENS. AFTER INSERTING THE LENS INTO THE PATIENT¿S RIGHT EYE, THE DOCTOR NOTICED IT WAS MISSING ONE HAPTIC. THE IOL WAS CUT OUT AND REPLACED WITH ANOTHER JNJ LENS OF THE SAME MODEL AND DIOPTER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17122946 ↗
• InjuryApr 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ZA9003 INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENTS RIGHT EYE. THE PATIENT WAS BLURRY SINCE THE ORIGINAL SURGERY. PATIENT ALSO HAD REFRACTIVE SURPRISE, HALOS AND VISUAL DISTURBANCE. THE LENS WAS EXPLANTED IN THE SECONDARY SURGERY AND REPLACED WITH COMPETITOR LENS. DIRECTIONS FOR USE WERE FOLLOWED. NO INCISION ENLARGEMENT OR SUTURES OR VITRECTOMY. SYMPTOMS PERSISTED FOR 5 MONTHS. PATIENT WAS FULLY RECOVERED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances; Visual Impairment

  MAUDE report 16753449 ↗
• InjuryMar 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IOL (INTRAOCULAR LENS) WAS EXPLANTED. THE REASON FOR THE EXPLANT WAS NOT INDICATED. THE EXPLANTED IOL WAS DISCARDED. FOLLOW-UP WAS DONE BUT NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 16517631 ↗
• InjuryFeb 23, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE IOL (INTRAOCULAR LENS) WAS FULLY INSERTED INTO THE PATIENT¿S RIGHT EYE. THE HAPTIC RIPPED OFF DURING INSERTION. THE IOL WAS CUT INTO PIECES TO REMOVE IT AND WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED. IT WAS ALSO REPORTED THAT THE PATIENT¿S CAPSULE TORE. THE DOCTOR ATTEMPTED TO IMPLANT ZA9003 21.0 DIOPTER HOWEVER, WAS UNABLE TO USE THAT AS WELL. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED WITH IOL MODEL ZCB00 21.5 DIOPTER. THE PATIENT¿S DAILY ACTIVITIES WERE NOT AFFECTED BY THIS EVENT, AND HAVE FULLY RECOVERED.

  Patient problems: Capsular Bag Tear

  MAUDE report 16433509 ↗
• InjuryFeb 15, 2023Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD A DEFECT AND THERE WAS PATIENT CONTACT. THE IOL WAS CUT OUT OF THE PATIENT'S OPERATIVE EYE. THERE WERE NO FURTHER COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16383727 ↗
• InjuryJan 31, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DISLOCATED AND THE LENS WAS EXPLANTED FROM THE LEFT EYE IN A SECONDARY SURGERY. A VITRECTOMY WAS REQUIRED. NO SUTURES WERE REQUIRED AND NO MEDICATION WAS PRESCRIBED. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (SAME MODEL, DIFFERENT DIOPTER OF 21.5). THE PATIENT IS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 16275386 ↗