TECNIS IOL ZXT300 (REF ZXT300U135)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474606258), received between Sep 25, 2017 and Jan 26, 2021 — classified as 3 injuries.

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. How this data works · Data updated Oct 13, 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.

• InjuryJan 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT HE HAD SURGERY ON BOTH EYES LAST YEAR. THE LEFT EYE (OS) A ZXT300 WAS IMPLANTED ON (B)(6) 2020 AND THE RIGHT EYE (OD) WAS IMPLANTED ON (B)(6) 2020. HE INDICATED HE ORIGINALLY HAD DRY EYE. WHEN THE PROCEDURES OCCURRED, HE WAS CURED OF HIS DRY EYE. HOWEVER, HE IS CURRENTLY SUFFERING VERY PAINFUL HEADACHES, FEELS LIKE HIS EYES ARE GOING TO EXPLODE, AND HAS DOUBLE VISION. HE IS HAVING PROBLEMS WITH BALANCE AND WALKING. THIS HAS CAUSED HIM TO FALL SEVERAL TIMES DUE TO HIS DOUBLE VISION AND MUST WEAR A CANE TO PREVENT FALLS. AND HE IS HAVING PROBLEMS READING TO UPDATE HIS LICENSING. HIS DOCTOR HAS MENTIONED THAT HIS DRIVING MIGHT BE AFFECTED, DUE TO HIS BAD VISION. HE IS (B)(6) YEARS OLD BUT CURRENTLY EMPLOYED AND IN NEED OF HIS VISION TO IMPROVE TO KEEP DRIVING. HIS ALLERGIST INDICATED HE MIGHT BE ALLERGIC TO THE LENSES. HE HAS SEEN FOUR DIFFERENT DOCTORS AND THEIR OPINIONS HAVE BEEN THAT HE MUST HAVE THE LENSES EXPLANTED HOWEVER THEY HAVE ALSO MENTIONED THAT IT IS A HIGH-RISK PROCEDURE. DOCTOR IS EXPECTING TO EXCHANGE LENSES BECAUSE HE WAS TOLD HIS EYES WERE REJECTING THE LENS. THE EXCHANGE IS SCHEDULED TO REPLACE IT WITH MONO-FOCAL LENSES. ADDITIONA

  Patient problems: Discomfort; Eye Pain; Headache; Hypersensitivity/Allergic reaction; Visual Impairment

  MAUDE report 11230807 ↗
• InjurySep 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT'S OPERATIVE EYE. POST OP VISUAL ACUITY WITH THIS, A REPLACEMENT LENS, WAS 20/100 WITH EDEMA. THE SURGEON STATED THE PATIENT HAS NOT HEALED YET AND WANTED TO WAIT ONE MORE MONTH. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Corneal Edema; No Code Available

  MAUDE report 9085043 ↗
• InjurySep 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (MODEL ZXT300, +13.5 DIOPTER) WAS ATTEMPTED TO BE IMPLANTED IN A PATIENT'S EYE. THERE WAS PATIENT CONTACT BUT THE LENS WAS NOT IMPLANTED. REPORTEDLY, A VITRECTOMY WAS PERFORMED AND A ZMA00 LENS (+13.0 DIOPTER) WAS IMPLANTED INSTEAD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Vitrectomy

  MAUDE report 6889451 ↗