TECNIS CL IOL Z9002 (REF Z900200270)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474530836), received between Mar 31, 2017 and Oct 1, 2020 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Optical Discoloration” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 1, 2020Adverse 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 DUE TO UNEXPECTED POST-OP REFRACTION/MYOPIA. THERE WAS NO INCISION ENLARGEMENT. IT WAS STATED THAT THE PATIENT HAS RECOVERED. NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10611366 ↗
• InjuryDec 6, 2018Optical Discoloration; Optical Discoloration

  IT WAS REPORTED THAT A Z9002 INTRAOCULAR LENS (IOL), 27.0 DIOPTER, THE DOCTOR NOTICED THAT DURING POST EXAMINATION 60 DAYS AFTER SURGERY HAD BECOME DARK. IT WAS STATED THAT THE INITIAL POST-SURGICAL VISUAL ACUITY (VA) 10/10. PATIENT COMPLAINING OF BLURRED VISION APPROXIMATELY 4 MONTHS POST-SURGICAL; HOWEVER, THE VA WAS 10/10. THE SUSPECT LENS WAS EXPLANTED. THERE WAS NO INCISION ENLARGED. REPLACEMENT LENS WAS A NON-JJSV IOL. THE PATIENT IS DOING FINE POST-OP WITH PERFECT VISION.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8136673 ↗
• InjuryOct 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A Z9002 27.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017, DUE TO MYOPIA. THERE WAS NO INCISION ENLARGEMENT OR PATIENT INJURY. THE LENS WAS REPLACED WITH THE SAME MODEL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6970345 ↗
• MalfunctionMar 31, 2017Scratched Material; Scratched Material

  IT WAS REPORTED THAT THERE WAS A PARACENTRAL METALLIC MARK IN THE OPTIC OF AN INTRAOCULAR LENS (IOL). REPORTEDLY, THE LENS WAS IMPLANTED AND NO FURTHER ACTION WAS TAKEN. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6451771 ↗