TECNIS CL IOL Z9002 (REF Z900200255)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474530805), received between Nov 17, 2016 and Aug 9, 2021 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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.

• MalfunctionAug 9, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A FULLY INSERTED INTRAOCULAR LENS (IOL) MODEL Z9002 WAS REMOVED AND REPLACED IN THE SAME PROCEDURE DUE TO LENS BEING TORN. THE REPLACEMENT LENS WAS ANOTHER JOHNSON AND JOHNSON IOL OF THE SAME MODEL AS WELL AS DIOPTER. ACCOUNT PROVIDED THAT PATIENT HAS RECOVERED. THE PRODUCT IS BEING RETURNED FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12298291 ↗
• InjuryMar 12, 2020Adverse 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 IMPLANTED IN THE PATIENT'S EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO RESIDUAL REFRACTIVE ERROR. THE REPLACEMENT LENS IS A NON-JOHNSON AND JOHNSON LENS. THERE WAS NO COMPLICATIONS, INJURY, OR ADDITIONAL SURGICAL INTERVENTION PERFORMED. THE CUSTOMER ALSO INDICATED THAT THE LENS WAS DISCARDED. REPORTEDLY, PATIENT IS DOING FINE POST-EXCHANGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9827433 ↗
• InjuryFeb 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL Z9002 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S OPERATIVE EYE IN A SECONDARY SURGICAL PROCEDURE ON THE SAME DAY AS INDICATED IN THE SOURCE DOCUMENT BECAUSE WRONG LENS WAS USED. CURRENT PATIENT STATUS IS PATIENT HAS RECOVERED AND OUTCOME DOES NOT INTERFERE WITH ACTIVITIES OF DAILY LIFE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 9770975 ↗
• InjuryMar 14, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A Z9002 25.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE IT WAS A MISS POWERED LENS. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 22.5. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7339750 ↗
• MalfunctionNov 17, 2016Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT RESIDUE WAS NOTICED ON AN INTRAOCULAR LENS (IOL) AFTER INSERTION INTO THE PATIENT'S EYE AND THE LENS WAS REMOVED. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THERE WAS A FILM ON TOP OF THE LENS NOTICED UPON IMPLANTATION. THE LENS WAS REMOVED AND REPLACED WITH A BACKUP LENS. NO INCISION ENLARGEMENT, NO SUTURE AND NO VITRECTOMY WAS PERFORMED. THE PATIENT WAS REPORTED BEING FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6111180 ↗