TECNIS IOL ZA9003 (REF ZA90030280)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474529175), received between Sep 19, 2017 and Oct 31, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ZA9003 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED DUE TO COMPLAINTS OF DYSPHOTOPSIA. THE EXPLANTED IOL WAS REPLACED WITH SAME MODEL IOL WITH A DIFFERENT DIOPTER SIZE, ZA9003 24.0 DIOPTER IOL. THERE WAS NO INCISION ENLARGEMENT AND NO VITRECTOMY. IT IS UNKNOWN IF THE PATIENT IS UNABLE TO ACCOMPLISH DAILY TASKS THAT HE/SHE WAS ABLE TO DO BEFORE SURGERY. IT IS ALSO UNKNOWN IF FURTHER MEDICAL CARE WAS NEEDED OR IF PRESCRIPTION MEDICINE WAS GIVEN (BEYOND THE SCOPE OF USUAL TREATMENT). PATIENT OUTCOME POST-LENS EXCHANGE WAS REPORTED AS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 18036512 ↗
• InjuryMar 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT RIGHT EYE CATARACT EXTRACTION DURING WHICH AN INTRAOCULAR LENS (IOL) WAS IMPLANTED. RE-EXAMINATION ON SURGERY DAY SHOWED VISUAL ACUITY OF 0.5 IN THE RIGHT EYE, MILD CONJUNCTIVAL CONGESTION, MILD CORNEAL EDEMA. ON (B)(6) 2023, THE PATIENT COMPLAINED OF PAIN AND DISCOMFORT. THE VISUAL ACUITY OF THE RIGHT EYE WAS 0.3, CONJUNCTIVAL CONGESTION, CORNEAL EDEMA, INFLAMMATORY EXUDATION IN THE ANTERIOR CHAMBER, LARGE INFLAMMATORY EXUDATION ON THE LENS SURFACE, AND NO SIGNIFICANT ABNORMALITY IN THE FUNDUS AFTER MYDRIASIS. INTRAOCULAR PRESSURE WAS 9.0 MMHG. THE FOLLOWING HAS BEEN PRESCRIBED: PREDNISOLONE ACETATE EYE DROPS 5 ML/VIAL 0.02 ML WAS APPLIED TO THE RIGHT EYE ONCE A HOUR, LEVOFLOXACIN EYE DROPS 0.02 ML WAS APPLIED TO THE RIGHT EYE ONCE A HOUR, TOBRAMYCIN DEXAMETHASONE EYE OINTMENT WAS APPLIED TO THE RIGHT EYE ONCE A NIGHT, ATROPINE SULFATE EYE GEL WAS APPLIED TO THE RIGHT EYE 3 TIMES A DAY, SODIUM CHLORIDE INJECTION 250 ML, DEXAMETHASONE SODIUM SQUAMOUS SOLUTION INJECTION 2 ML AND CEFTAZIDIME FOR INJECTION 3 G WERE INTRAVENOUSLY INFUSED ONCE A DAY FOR TREATMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Corneal Edema; Eye Pain; Inflammation

  MAUDE report 16464451 ↗
• InjuryDec 14, 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 REFRACTIVE SURPRISE WITH GLARE AND WEBBING. SUTURES PERFORMED. IT WAS INDICATED THAT THE PATIENT¿S DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. IOL WAS REPLACED WITH THE SAME MODEL WITH DIFFERENT DIOPTER POWER SIZE IOL. NO OTHER INTERVENTIONS OR DELAY REPORTED. THE PATIENT FULLY RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances; Visual Impairment; Vitreous Floaters

  MAUDE report 15981503 ↗
• InjuryJul 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON IMPLANTED THE INTRAOCULAR LENS (IOL) ZA9003 WHICH STAYED IN PLACE UNTIL THE SURGEON WAS SUTURING THE WOUND WHEN THE LENS DISAPPEARED INTO THE VITREOUS. THIS IS BECAUSE THE SURGEON IMPLANTED THE LENS INTO THE SULCUS. SALES REP HAD ADVISED THAT PLACING THE J&J 3-PIECE LENSES IN THE SULCUS WAS OFF LABEL USE. IOL WAS EXPLANTED DURING SECONDARY SURGERY ON (B)(6) 2021 WITH VITRECTOMY AND SUTURE PERFORMED. PRODUCT NOT AVAILABLE FOR RETURN. IT WAS STATED THAT THE PATIENT WILL DO WELL ONCE HER EYE SETTLES. NO FURTHER INFORMATION AVAILABLE.

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

  MAUDE report 12185959 ↗
• InjuryJan 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZA9003 28.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO A RESIDUAL REFRACTIVE ERROR. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS A NON-JOHNSON AND JOHNSON LENS. REPORTEDLY, THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8295185 ↗
• InjurySep 19, 2017Break; Break

  IT WAS REPORTED THAT A ZA9003 28.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO A BROKEN HAPTIC. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6878089 ↗