TECNIS IOL ZA9003 (REF ZA90030255)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05050474529120), received between Nov 7, 2016 and May 25, 2023 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (4 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.

• InjuryMay 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 RIGHT EYE DUE TO MYOPIC REFRACTIVE SURPRISE. SUSPECT IOL WAS REPLACED WITH A DIB00, 24.5 DIOPTER POWER SIZE IOL. THERE NO OTHER SURGICAL OR MEDICAL INTERVENTIONS REQUIRED. THE PATIENT FULLY RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 17008237 ↗
• InjuryMay 11, 2022Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT THE SURGEON HAD PLANNED ON USING A PRELOADED INTRAOCULAR LENS (IOL), MODEL PCB00, AS IT IS THEIR STANDARD PRACTICE. HOWEVER, HALFWAY THROUGH PHACOEMULSIFICATION, A SMALL CAPSULE TEAR WAS OBSERVED. ACCOUNT'S BRIEF DESCRIPTION OF THE EVENT PROVIDED THAT THE SURGEON REQUESTED A 3-PIECE LENS (SUSPECT IOL, MODEL: ZA9003, 25.5 DIOPTER POWER) AND IMPLANTED IT IN THE SULCUS. THE SURGEON DID NOT NOTICE THAT THE HAPTIC WAS BENT UNTIL THE LENS HAD BEEN DEPLOYED INSIDE THE CAPSULE AND DECIDED TO REPLACE THE LENS. ACCOUNT BELIEVES THAT THE BENT HAPTIC WAS A HANDLING/LOADING PROBLEM. IT WAS INDICATED THAT THE INCISION WAS ENLARGED WITH A A 5.2 BLADE TO PULL THE REMAINDER OF THE PARTIALLY CUT LENS OUT OF THE PATIENT'S LEFT EYE AS IT WAS DIFFICULT TO REMOVE THE LENS. BY THE TIME THE IOL WAS COMPLETELY REMOVED, THE CAPSULE HAD DETERIORATED FURTHER AND COULD NO LONGER SUPPORT ANOTHER SULCUS LENS. THEREFORE, A COMPETITOR ANTERIOR CHAMBER LENS (23.5 DIOPTER POWER) WAS IMPLANTED AND SUTURING WAS REQUIRED TO CLOSE THE INCISION. THE CASE WAS ABOUT AN HOUR LONG, TRIPLE THE SURGEON'S USUAL TIME. IT WAS PROVIDED THAT 20 MG OF TRIAMCINOLONE WAS ADMINISTERED DUE TO THE EXCESSIVE MANIPULAT

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

  MAUDE report 14365940 ↗
• MalfunctionOct 22, 2021Break; Inaccurate Delivery; Break; Inaccurate Delivery

  IT WAS REPORTED THAT A ZA9003 MODEL INTRAOCULAR LENS(IOL) HAD HAPTIC BENT UPON INSERTION INTO THE PATIENT'S LEFT EYE. THE LENS WAS PARTIALLY INSERTED AND REMOVED IN THE SAME PROCEDURE. NO MEDICAL/ SURGICAL INTERVENTIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY OR SUTURES WERE NOT DONE. THERE WAS NO DELAY IN PROCEDURE REPORTED. THE ISSUE DID NOT SIGNIFICANTLY AFFECT PATIENT'S DAILY ACTIVITIES AND THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12678352 ↗
• InjuryApr 6, 2021Break; Break

  IT WAS REPORTED THAT LENS WAS IMPLANTED AND HAD TO BE CUT OUT BECAUSE OF DAMAGED HAPTIC. INCISION WAS ENLARGED IN ORDER TO REMOVE IT AND REPLACE. NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION AVAILABLE.

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

  MAUDE report 11620674 ↗
• InjuryApr 6, 2021Break; Break

  IT WAS REPORTED THAT LENS WAS IMPLANTED AND HAD TO BE CUT OUT BECAUSE OF DAMAGED HAPTIC. INCISION WAS ENLARGED IN ORDER TO REMOVE IT AND REPLACE. NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION AVAILABLE.

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

  MAUDE report 11620583 ↗
• InjuryOct 5, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHEN THE SURGEON IMPLANTED THE SUSPECT LENS INTO THE PATIENT¿S EYE, IT HAD CAPSULE TEAR. THEN THE INTRAOCULAR LENS (IOL) FLOATED INTO THE BACK OF THE EYE AND WAS NOT ABLE TO BE RETRIEVED. ALCON ANTERIOR LENS WAS PLACED ON TOP. IT WAS STATED THAT THE PATIENT IS BEING SEEN BY A RETINA SPECIALIST. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 10632110 ↗
• InjuryApr 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZA9003 25.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018 AND WAS LATER EXPLANTED ON (B)(6) 2019. PLANO WAS NOT ACHIEVED, GOAL -2.0, BUT GOT -5.0 POST-OPERATIVELY. PATIENT COULD NOT TOLERATE MYOPIA/ANISOMETROPIA. LASIK WAS PERFORMED AND ORA (OCULAR RESPONSE ANALYZER) VERIFICATION WAS COMPLETED. A SAME MODEL LENS WAS USED FOR THE REPLACEMENT AND THE INCISION WAS ENLARGED. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8563270 ↗
• InjuryJan 17, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZA9003 INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENTS EYE. REPORTEDLY, THE LENS WAS THE WRONG POWER AND WAS EXPLANTED. THE RIGHT LENS WAS IMPLANTED. NO ADDITIONAL INTERVENTION WAS PERFORMED.

  Patient problems: No Code Available

  MAUDE report 8258710 ↗
• InjurySep 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZA9003 25.5 DIOPTER INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT'S OPERATIVE EYE BUT THEN IT WAS REMOVED AND REPLACED WITH A ZA9003 25.0 DIOPTER DURING THE SAME SURGICAL PROCEDURE. REPORTEDLY, A VITRECTOMY WAS PERFORMED AND NO ISSUES FOR THE PATIENT WERE REPORTED. THE ACCOUNT COMMENTED THAT THE LENS IS NOT AVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vitrectomy

  MAUDE report 7867971 ↗
• InjuryJan 18, 2017Bent; Bent

  IT WAS REPORTED THAT DURING IMPLANTATION OF A ZA9003 INTRAOCULAR LENS (IOL), THE TRAILING HAPTIC WAS OBSERVED TO BE BENT AS THE LENS WAS BEING INSERTED. THE LENS WAS CUT IN HALF AND REMOVED. THE PHYSICIAN NOTED THAT THE CAPSULE BAG BROKE AND A NON-AMO DEVICE WAS USED AS A LENS REPLACEMENT. THROUGH FOLLOW UP THE CUSTOMER INDICATED THAT THERE WAS NO RECORD OF INCISION ENLARGEMENT FOR THIS EVENT. THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 6260861 ↗
• MalfunctionNov 7, 2016Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE DR. REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THE DEFECT WAS NOTICED PRIOR TO LOADING THE IOL INTO THE CARTRIDGE. THE DR. WAS ABLE TO USE ANOTHER IOL OF THE SAME MODEL AND DIOPTER. THE PATIENT'S OUTCOME IS SATISFACTORY. AMO RECEIVED INFORMATION FROM THE CUSTOMER CLARIFYING THAT HE BELIEVES THERE WAS BLACK DEBRIS ON THE IOL. THE LENS OR CARTRIDGE DID NOT TOUCH THE EYE. NO INJURY TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Patient Involvement

  MAUDE report 6082057 ↗