TECNIS CL IOL Z9002 (REF Z900200145)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474530584), received between Jul 7, 2017 and Jan 23, 2019 — classified as 2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2019Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF A Z9002 14.5 DIOPTER INTRAOCULAR LENS (IOL) BROKE INSIDE THE PATIENT'S OPERATIVE EYE DURING IMPLANTATION. THEREFORE, THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS, SAME MODEL AND DIOPTER. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY WAS PERFORMED, NO SUTURES WERE USED AND NO PATIENT INJURY OCCURRED. THE PATIENT WAS REPORTED DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8270122 ↗
• MalfunctionOct 15, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A MODEL Z9002 INTRAOCULAR LENS HAD DEBRIS ON IT. THIS WAS OBSERVED DURING HANDLING, BUT PRIOR TO INSERTION. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7968118 ↗
• InjuryMay 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A Z9002 14.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018, DUE TO THE LENS DISLOCATING AFTER SCLERAL FIXATION. THERE WAS NO INCISION ENLARGEMENT AND THE PATIENT RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7478435 ↗
• InjuryJul 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT A Z9002 14.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S EYE AS THE PHYSICIAN BELIEVED THAT THE LENS WAS MISLABELED WITH INCORRECT POWER. THE PATIENT MEASURED +6 POST-OP. THE 14.5 DIOPTER LENS WAS REPLACED ANOTHER Z9002 IOL OF A HIGHER DIOPTER (15.0). THE PATIENT WAS REPORTED TO BE DOING BETTER. AS A RESULT OF FOLLOW-UP IT WAS LEARNED THAT THE PHYSICIAN NOW BELIEVES THAT THE IMPLANT WAS CORRECTLY LABELED AS THE PATIENT ENDED UP A +6 AGAIN WITH THE IOL EXCHANGE OF ROUGHLY THE SAME POWER. PER THE PHYSICIAN, THE PATIENT IS GETTING ANOTHER OPINION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6692161 ↗