TECNIS IOL ZA9003 (REF ZA90030130)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474528871), received between Jun 8, 2018 and Oct 29, 2022 — classified as 4 injuries, 4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 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 LEFT EYE (OS) DUE TO THE PATIENT WAS EXPERIENCING DYSPHOTOPSIA. A NON-JOHNSON & JOHNSON LENS WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO REPORTED PATIENT INJURY AND PATIENT IS STATED TO BE FULLY RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 15695771 ↗
• InjuryMay 21, 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 FULLY INSERTED AND REMOVED IN THE SAME PROCEDURE DUE TO CAPSULE TEAR/COLLAPSE. THE CAPSULE/ZONULAR SUPPORT WAS NOT SUFFICIENT TO SUPPORT THE LENS. THE PROCEDURE WAS NOT COMPLETED USING ANOTHER IOL. THE IOL WILL NOT BE RETURNED FOR INVESTIGATION AS IT WAS DISCARDED. THE PATIENT'S POST-OPERATIVE OUTCOME WAS NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 14466758 ↗
• MalfunctionDec 1, 2021Break; Failure to Fold; Break; Failure to Fold

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WHILE BEING INSERTED INTO THE EYE WAS NOTED TO HAVE FOLDING ISSUE AND THERE WAS A BENT/KINKED HAPTIC. ONLY THE CARTRIDGE TOUCHED THE PATIENT'S EYE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12910050 ↗
• MalfunctionNov 10, 2021Break; Break

  IT WAS REPORTED THAT THE DOCTOR ENCOUNTERED AN ISSUE WITH THE INJECTOR OF A PRELOADED INTRAOCULAR LENS (IOL). THERE WAS A PROBLEM WITH LOADING AND DELIVERY OF THE LENS INTO THE PATIENT'S EYE. THE DOCTOR THEN PROCEEDED USING ANOTHER IOL, A 3-PIECE, MODEL ZA9003 LENS. THE LENS HAPTIC BROKE ONCE IT WAS INJECTED INTO THE PATIENT'S EYE. THE LENS WAS THEN REMOVED FROM THE EYE AND THE PATIENT WAS LEFT APHAKIC. THE DOCTOR INDICATED THAT THE PATIENT WILL NEED TO HAVE A 3-PIECE LENS FOR SULCUS IMPLANTATION AS A REPLACEMENT LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12785141 ↗
• MalfunctionOct 22, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE DOCTOR NOTED THE "STRIATIONS" (SCRATCHES) ALL OVER ON POSTERIOR SIDE OF THE LENS ONLY AFTER THE INTRAOCULAR LENS (IOL) HAS ALREADY BEEN IMPLANTED IN THE PATIENT. NO VISUAL ISSUES. PATIENT SO FAR IS OK. THE CUSTOMER WILL NOTIFY US IF THERE WILL BE INFORMATION OF VISUAL ISSUES LATER. EMERALDC CARTRIDGE USED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12683601 ↗
• InjurySep 28, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S RIGHT EYE DUE TO IT'S SPONTANEOUS POSTERIOR DISLOCATION IN THE EYE WHICH WAS NOTICED DURING POST-OPERATIVE VISIT. A NEW INCISION WAS MADE AND ANOTHER LENS OF SAME MODEL AND DIOPTER WAS PLACED AS THE REPLACEMENT. A VITRECTOMY WAS ALSO PERFORMED. NO FURTHER INFORMATION WAS AVAILABLE.

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

  MAUDE report 12538474 ↗
• MalfunctionOct 20, 2018Separation Problem; Separation Problem

  IT WAS REPORTED THE HAPTIC OF ZA9003 13.0 DIOPTER INTRAOCULAR LENS (IOL) WAS TORN OFF. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7988095 ↗
• InjuryJun 8, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT'S LEFT EYE HAD AN ANTERIOR AND SMALL POSTERIOR CAPSULAR TEAR, THEREFORE THE ZA9003 INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE SULCUS ON (B)(6) 2018. REPORTEDLY, THE LENS WAS EXPLANTED ON (B)(6) 2018 AS THE IOL WAS DISLOCATED VERTICALLY (ANTERIOR & POSTERIOR) WITH IRIS HEMORRHAGE. THE REPLACEMENT LENS WAS A COMPETITOR LENS. THERE WAS NO INCISION ENLARGEMENT AND NO VITRECTOMY WAS PERFORMED. THE PATIENT HAD MILD CORNEAL EDEMA WITH VISUAL ACUITY OF 20/50 ONE WEEK POST-OP. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Capsular Bag Tear; Corneal Edema; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7581573 ↗