TECNIS CL IOL Z9002 (REF Z900200275)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474530843), received between Sep 22, 2017 and Feb 24, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS INDICATED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT¿S RIGHT EYE DUE TO COMPLICATION WITH THE LENS. A NON-JOHNSON AND JOHNSON SULCUS LENS OF A DIFFERENT DIOPTER (28.0 D) WAS USED AS THE REPLACEMENT. A VITRECTOMY WAS PERFORMED, AND SUTURE WAS USED. IT WAS INDICATED THAT THE PATIENT IS HEALING WELL. ADDITIONALLY, IT WAS EXPLAINED THAT AT THE TIME OF CATARACT SURGERY IN 2021, THE PATIENT DID NOT HAVE A GOOD EYE HEALTH TO START WITH. THAT THIS WAS A COMPLEX CATARACT SURGERY WHICH LYSIS OF SYNECHIA WAS REPORTED ON (B)(6) 2021, THERE WAS DISCONTINUOUS CAPSULE AND THE PATIENT HAD BLURRY VISION. BUT THE ACCOUNT WAS NOT SURE IF THIS INFORMATION PERTAINED TO PATIENT'S ISSUES PRIOR TO CATARACT SURGERY OF AFTER THE LENS WAS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Capsular Bag Tear

  MAUDE report 16439982 ↗
• MalfunctionJun 2, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN Z9002 INTRAOCULAR LENS (IOL) IN THE LEFT EYE (OS) WAS FULLY INSERTED AND REMOVED DURING THE SAME PROCEDURE AS THE LENS WAS TORN WHILE INSERTING INTO THE EYE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND DIOPTER) AS A REPLACEMENT. THERE WERE NO SURGICAL INTERVENTION REQUIRED, NO VITRECTOMY, SUTURES OR INCISION ENLARGEMENT. THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11925802 ↗
• InjurySep 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A VITRECTOMY WAS PERFORMED AND THEN AN INTRAOCULAR LENS WAS IMPLANTED. AFTER THE INSERTION OF A Z9002 27.5 DIOPTER INTRAOCULAR LENS (IOL) INTO THE SULCUS OF THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017, A CAPSULAR TEAR OCCURRED CAUSING THE LENS TO FALL BACK INTO THE EYE. IT WAS THEN REMOVED AND REPLACED WITH A BACK UP LENS. THERE WAS NO REPORTED INCISION ENLARGEMENT OR SUTURES USED. THE PATIENT HAS RECOVERED AND THE OUTCOME DOES NOT INTERFERE WITH ACTIVITIES OF DAILY LIFE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 6889044 ↗