TECNIS IOL ZXT300 (REF ZXT300U205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474606395), received between Nov 1, 2016 and Jul 25, 2019 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED ZXT300 20.5 DIOPTER INTRAOCULAR LENS (IOL) MODEL WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2019. THE IMPLANTED IOL ROTATED DUE TO AN UNSPECIFIED PATIENT ISSUE AND WAS REPOSITIONED ON (B)(6) 2019. IT WAS REPORTED NO SURGICAL/MEDICAL INTERVENTION WAS REQUIRED. THE LENS REMAINS IMPLANTED IN THE PATIENT¿S EYE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 8825754 ↗
• InjuryFeb 28, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZXT300, 20.5 DIOPTER STUDY INTRAOCULAR LENS (IOL) ROTATED FROM 90 DEGREES TO 68 DEGREES AFTER ALMOST A MONTH. IOL REPOSITIONING SURGERY THEN WAS SCHEDULED FOR (B)(6) 2019. THROUGH FOLLOW-UP IT WAS LEARNT THAT THE SUBJECT COMPLAINED OF BLURRY VISION IN THE LEFT EYE AT THEIR FOLLOW UP APPOINTMENT BUT DID NOT MENTION THAT SYMPTOMS SIGNIFICANTLY INTERFERE WITH REGULAR ACTIVITIES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8380813 ↗
• InjuryAug 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXPLANT OF A TECNIS SYMFONY TORIC INTRAOCULAR LENS (IOL), MODEL ZXT300 20.5 DIOPTERS, ON (B)(6) 2017 IN THE RIGHT EYE DUE TO REFRACTIVE ERROR / IOL COMPLICATION. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES, OR POST-OPERATIVE INJURIES. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6806007 ↗
• InjuryNov 1, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT HE HAS A POST-OP SURPRISE WITH ONE OF HIS SYMFONY TORIC LENS. PATIENT RECEIVED 20.5 DIOPTER ZXT300 INTRAOCULAR LENS (IOL) USING ORA (OCULAR RESPONSE ANALYZER), AND NOW PATIENT IS +1.50 HYPEROPIC WITH -1.50CYL AND A VISUAL ACUITY 20/50 AT DISTANCE. LENS MAY HAVE ROTATED A BIT POST-OP CAUSING RESIDUAL ASTIGMATISM BUT MORE CONCERNING TO THE DOCTOR IS THE HYPEROPIA. FROM THE PHYSICIAN'S CALCULATION, 20.5 ZXT300 SHOULD HAVE GOTTEN THE PATIENT -0.11 DIOPTER. PATIENT WAS SCHEDULED FOR A RE-OP HOWEVER THROUGH FOLLOW UP THE PHYSICIAN INDICATED THAT THE DEVICE WILL NOT BE RETURNED AND THAT AN IOL EXCHANGE MIGHT NOT BE NECESSARY.

  Patient problems: No Code Available

  MAUDE report 6068592 ↗