TECNIS IOL ZA9003 (REF ZA90030115)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05050474528840), received between Nov 7, 2016 and Dec 5, 2025 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE CUSTOMER THAT A PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL), MODEL ZA9003, WAS FULLY IMPLANTED IN THE PATIENT¿S LEFT EYE. DURING FOLLOW-UP CONSULTATION, THE PATIENT EXPERIENCED VISUAL DISTURBANCES, AND THE LENS WAS FOUND TO BE SUBLUXED OR DISLOCATED. IT IS UNKNOWN IF THE ISSUE IMPACTED PATIENT'S DAILY ACTIVITIES. A SECONDARY SURGICAL PROCEDURE WAS PERFORMED TO EXPLANT THE ORIGINAL LENS AND REPLACE IT WITH AN AR40E LENS (+10.5 DIOPTER). AN UNPLANNED VITRECTOMY WAS REQUIRED; HOWEVER, THERE WERE NO REPORTS OF INCISION ENLARGEMENT OR UNPLANNED SUTURES. THE PATIENT HAS FULLY RECOVERED. THE DIRECTIONS FOR USE WERE FOLLOWED. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 23731905 ↗
• InjuryNov 7, 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 FROM THE PATIENT'S RIGHT EYE DUE TO SUBJECTIVE VISUAL DISTURBANCES. PATIENT REPORTS FLASHES EFFECT OF LIGHT, VARIOUS ANGLES OF DARK, EYE ACHES WHICH WERE FIRST OBSERVED DURING POST-OPERATIVE EXAMINATION. INCISION WAS ENLARGED. PATIENT HAS FULLY RECOVERED. EXPLANTED IOL WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Pain; Flashers; Visual Disturbances

  MAUDE report 15749601 ↗
• MalfunctionFeb 14, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT'S OPERATIVE EYE, HOWEVER, IT WAS REMOVED DURING THE SAME PROCEDURE AS THE LENS WAS SCRATCHED. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT IOL. THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTION WAS REQUIRED. THE PATIENT WAS DOING GOOD POST OPERATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13529348 ↗
• MalfunctionJun 8, 2021Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF THE INTRAOCULAR LENS (IOL) BROKE. THE LENS WAS FULLY INSERTED INTO PATIENT'S LEFT EYE AND WAS REMOVED AND REPLACED WITH ANOTHER LENS OF SAME MODEL AND DIOPTER (B)(4) DURING THE SAME PROCEDURE. HOWEVER, THERE WAS NO PATIENT INJURY AND NO INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11963235 ↗
• InjuryApr 14, 2021Adverse 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 PATIENT'S LEFT EYE FOR UNKNOWN REASON. ANOTHER LENS OF DIFFERENT MODEL WAS USED AS REPLACEMENT. THERE WAS NO CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 11665210 ↗
• MalfunctionDec 12, 2019Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZA9003 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S EYE. REASON FOR EXPLANT IS UNKNOWN/NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9463610 ↗
• InjuryJul 26, 2019Positioning Failure; Positioning Failure

  DURING A CATARACT PROCEDURE, THE CAPSULAR BAG TORE, RESULTING IN A VITRECTOMY PROCEDURE. A ZA9003 THREE-PIECE INTRAOCULAR LENS (IOL) WAS PLACED AFTER THE VITRECTOMY PROCEDURE, HOWEVER, ONCE INSERTED, THE 3 PIECE IOL WOULD NOT SIT CORRECTLY. AN INCISION ENLARGEMENT WAS REQUIRED TO REMOVE THE SUSPECTED IOL AND REPLACE WITH ANOTHER IOL. IT WAS REPORTED THE PATIENT OUTCOME IS WELL.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 8833835 ↗
• MalfunctionNov 20, 2017Bent; Bent

  IT WAS REPORTED THAT THE TRAILING HAPTIC OF A ZA9003 11.5 DIOPTER INTRAOCULAR LENS (IOL) WAS NOTICED CRIMPED UPON INSERTION INTO THE PATIENT'S OPERATIVE EYE. THEREFORE, THE LENS WAS REMOVED AND ANOTHER LENS WAS INSERTED WITHOUT INCIDENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7047541 ↗
• MalfunctionOct 3, 2017Scratched Material; Scratched Material

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS NOTICED SCRATCHED UPON REMOVING IT FROM THE LENS CASE. NO PATIENT CONTACT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6911742 ↗
• InjuryMar 1, 2017Adverse 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 AS THE PATIENT COULD NOT TOLERATE THE LENS. THE PHYSICIAN WAS TARGETING -1.00 WITH A 11.50 IOL, HOWEVER GOT +4.12. THERE WAS NO INCISION ENLARGEMENT OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY REQUIRED. THE LENS WAS REPLACED WITH THE SAME MODEL LENS WITH A DIFFERENT DIOPTER SIZE (19.5).

  Patient problems: No Code Available

  MAUDE report 6370927 ↗
• InjuryNov 7, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZA9003 11.5 DIOPTER INTRAOCULAR LENS WAS EXPLANTED DUE TO PATIENT BEING MORE HYPEROPIC THEN DESIRED. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY POST-OP. THE LENS WAS REPLACED A SAME MODEL LENS OF A 13.0 DIOPTER.

  Patient problems: No Code Available

  MAUDE report 6084702 ↗