TECNIS CL IOL Z9002 (REF Z900200170)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474530638), received between Dec 29, 2016 and Feb 3, 2022 — classified as 3 injuries, 2 malfunctions.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO PATIENT'S LEFT EYE, HOWEVER, WAS REMOVED DURING THE SAME PROCEDURE AS THE FRONT HAPTIC BROKE OFF. THE INCISION WAS ENLARGED AND ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. THE PATIENT WAS FINE POST OPERATION. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 13447314 ↗
• InjuryNov 30, 2018Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE Z9002 INTRAOCULAR LENS (IOL) WAS INSERTED AND REMOVED FROM THE PATIENT'S OPERATIVE EYE, DUE TO A MISSING HAPTIC. THE ACCOUNT COMMENTED THAT HAPTIC WAS POSSIBLY AMPUTATED DURING LOADING. AN INCISION ENLARGEMENT WAS REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACK-UP LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8119016 ↗
• MalfunctionOct 31, 2018Break; Break

  IT WAS REPORTED THAT INTRAOCULAR LENS HAD TORN OR BROKEN HAPTIC WHICH WAS IMPLANTED, REMOVED AND REPLACED IN THE SAME PROCEDURE. THERE WAS NO LENS TO RETURN FOR INVESTIGATION. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES AND NO VITRECTOMY PERFORMED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8027092 ↗
• InjuryFeb 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A Z9002, 17.0 DIOPTER INTRAOCULAR LENS (IOL) WAS FULLY INSERTED IN THE LEFT EYE (OS) OF A PATIENT AND REMOVED AS THERE WAS NOT ENOUGH CAPSULE TO SUPPORT THE LENS. IT WAS INDICATED THAT THERE WAS NO PRODUCT ISSUE. A VITRECTOMY AND INCISION ENLARGEMENT WERE REQUIRED AND FOUR (4) SUTURES WERE PLACED. THE SURGERY WAS COMPLETED SUCCESSFULLY AND AN ANTERIOR CHAMBER LENS WAS IMPLANTED. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 7264205 ↗
• InjuryDec 29, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A Z9002 INTRAOCULAR LENS (IOL) WAS REMOVED FROM PATIENT'S RIGHT EYE DUE TO ANISOMETROPIA. THE REPLACEMENT LENS IS UNKNOWN. THERE WAS NO PATIENT INJURY AND NO WOUND ENLARGEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6214750 ↗