TECNIS IOL ZXT300 (REF ZXT300U100)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474606180), received between Apr 2, 2017 and Jul 3, 2018 — classified as 2 injuries, 1 malfunction.

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

• MalfunctionJul 3, 2018Crack; Device Contamination with Chemical or Other Material; Torn Material; Crack; Device Contamination with Chemical or Other Material; Torn Material

  IT WAS REPORTED THAT THE SURGEON DID NOT THINK THAT THE INTRAOCULAR LENS (IOL) LOOKED NORMAL. REPORTEDLY, THE LENS HAD DEBRIS AND IT WAS CRACKED/TORN. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7658047 ↗
• InjuryApr 2, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT AFTER IMPLANTATION OF A ZXT300 INTRAOCULAR LENS, AT 1 WEEK POST OP, THE PATIENT WAS EXPERIENCING DYSPHOTOPSIA, STARBURSTS AND FLARE, ESPECIALLY AT DARK. AN EXAM ON THE PATIENT'S EYE SHOWED THAT THE LENS WAS APPROXIMATELY 17 DEGREES OFF AXIS, INSTEAD OF 93 IT WAS AT 110. AS A RESULT THE PHYSICIAN IS PLANNING ON REPOSITIONING THE LENS. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED. IT WAS LEARNED THAT LENS WAS IMPLANTED IN A MALE PATIENT'S RIGHT EYE. PATIENT WAS EXPERIENCING MORE GLARE, STARBURST, HALOS AND PATIENT IS VERY DISSATISFIED. THE PATIENT IS ALSO EXPERIENCING DISTORTION AND BLURRED VISION. THROUGH ADDITIONAL FOLLOW UP IT WAS LATER LEARNED THAT THE PATIENT IS DOING FINE. ON (B)(6) 2017 - OD VISUAL ACUITY (POST OP DAY 1): DISTANCE - 20/100 PH: 20/40. ON (B)(6) 2017 - OD VISUAL ACUITY: DISTANCE - 20/40. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 6452390 ↗
• InjuryApr 2, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT AFTER IMPLANTATION OF A ZXT300 INTRAOCULAR LENS, AT 1 WEEK POST OP, THE PATIENT WAS EXPERIENCING DYSPHOTOPSIA, STARBURSTS AND FLARE, ESPECIALLY AT DARK. AN EXAM ON THE PATIENT'S EYE SHOWED THAT THE LENS WAS APPROXIMATELY 17 DEGREES OFF AXIS, INSTEAD OF 93 IT WAS AT 110. AS A RESULT THE PHYSICIAN IS PLANNING ON REPOSITIONING THE LENS. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED. IT WAS LEARNED THAT LENS WAS IMPLANTED IN A MALE PATIENT'S RIGHT EYE. PATIENT WAS EXPERIENCING MORE GLARE, STARBURST, HALOS AND PATIENT IS VERY DISSATISFIED. THE PATIENT IS ALSO EXPERIENCING DISTORTION AND BLURRED VISION. THROUGH ADDITIONAL FOLLOW UP IT WAS LATER LEARNED THAT THE PATIENT IS DOING FINE. (B)(6) 2017 - OD VISUAL ACUITY (POST OP DAY 1): DISTANCE - 20/100 PH: 20/40. (B)(6) 2017 - OD VISUAL ACUITY: DISTANCE - 20/40. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 6451862 ↗