TECNIS IOL ZXT300 (REF ZXT300U175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474606333), received between Jan 12, 2017 and Sep 12, 2022 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (2 reports).

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.

• InjurySep 12, 2022Adverse 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 RIGHT EYE DUE TO PATIENT HAD DYSPHOTOPSIAS THAT WERE NOT MORE EXTREME THAN NORMAL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 15407520 ↗
• MalfunctionOct 24, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) ROTATED 10 DEGREES, THEREFORE, THE LENS WAS REPOSITIONED IN A SECONDARY PROCEDURE. THROUGH FOLLOW UP, IT WAS LEARNED THAT THERE WAS NO PATIENT INJURY. THE PATIENT IS DOING MUCH BETTER POST REPOSITION AND IS HAPPY NOW. NO ADDITIONAL INFORMATION WAS PROVIDED. PATIENT HAD BILATERAL LENS IMPLANTS. THIS REPORT CAPTURES THE LENS IMPLANTED IN PATIENTS RIGHT EYE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9234121 ↗
• MalfunctionOct 24, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) ROTATED 10 DEGREES, THEREFORE, THE LENS WAS REPOSITIONED IN A SECONDARY PROCEDURE. THROUGH FOLLOW UP, IT WAS LEARNED THAT THERE WAS NO PATIENT INJURY. THE PATIENT IS DOING MUCH BETTER POST REPOSITION AND IS HAPPY NOW. NO ADDITIONAL INFORMATION WAS PROVIDED. PATIENT HAD BILATERAL LENS IMPLANTS. THIS REPORT CAPTURES THE LENS IMPLANTED IN PATIENTS LEFT EYE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9233969 ↗
• InjuryJul 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXT300, +17.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE BECAUSE OF PATIENT EXPERIENCING RESIDUAL ASTIGMATISM. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT LENS WITH MODEL ZXT225 +17.5 DIOPTER WAS USED AS REPLACEMENT FOR THE PATIENT. GLUE WAS USED DURING THE PROCEDURE AND THERE WAS NO PATIENT INJURY. PATIENT WAS DOING GOOD AT DISCHARGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7672024 ↗
• MalfunctionJan 12, 2017Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD A SCRATCH AND WAS REMOVED FROM THE EYE. ANOTHER IOL OF THE SAME MODEL AND DIOPTER WAS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6248432 ↗