TECNIS CL IOL Z9002 (REF Z900200160)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474530614), received between Jul 17, 2017 and Sep 30, 2019 — classified as 2 injuries.

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

• InjurySep 30, 2019Adverse Event Without Identified Device or Use Problem; Inaccurate Information; Adverse Event Without Identified Device or Use Problem; Inaccurate Information

  IT WAS REPORTED THAT THE INTRAOCULAR LENS WAS EXPLANTED FROM THE PATIENTS OPERATIVE EYE DUE TO RESIDUAL REFRACTIVE ERROR. THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS OF THE SAME MODEL. THERE WAS NO ADDITIONAL INTERVENTION REQUIRED AND THE PATIENT WAS DOING GOOD POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Code Available

  MAUDE report 9134170 ↗
• InjuryJul 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A Z9002 16.0 DIOPTER INTRAOUCLAR LENS WAS EXPLANTED FROM A FEMALE PATIENT'S RIGHT EYE DUE TO MYOPIC OUTCOME. THERE WAS NO ISSUE WITH THE LENS, THE PHYSICIAN ATTRIBUTES THE EVENT TO PATIENT ISSUES. THE LENS WAS REPLACED WITH THE SAME MODEL LENS WITH A LOWER DIOPTER SIZE (13.5). THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES REQUIRED. THERE WAS NO PATIENT POST-OP INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6720381 ↗