TECNIS IOL ZXT300 (REF ZXT300U120)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474606227), received between May 18, 2017 and Oct 25, 2019 — classified as 5 injuries.

The most frequently reported specific device problem is “Unintended Movement” (3 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.

• InjuryOct 25, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZXT300 INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2019, WITH A PLACEMENT AT AXIS 76. ON AN UNSCHEDULED POST OP VISIT, (B)(6) 2019, THE LENS HAD ROTATED 18 DEGREES TO AN AXIS OF 94. PATIENT COMPLAINED OF IFFY (BLURRY) VISION AND SLIGHT DOUBLE VISION WITH ROAD SIGNS. IOL REPOSITIONING WAS DONE ON (B)(6) 2019 WITH PLACEMENT AT 80 AXIS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9242403 ↗
• InjurySep 30, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZXT300 12.0 DIOPTER LENS WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE DUE TO THE LENS ROTATING 38 DEGREES. THE LENS WAS REPLACED WITH THE SAME MODEL, A ZXT300 BUT DIOPTER 13.0. THERE WERE NO COMPLICATIONS. REPORTEDLY, THE PATIENT IS DOING FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9137869 ↗
• InjuryJul 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT300 +12.0 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE ON (B)(6) 2018. REPORTEDLY, THIS LENS WILL BE EXPLANTED IN THE FUTURE. THE REASON FOR THE PLANNED EXPLANT WAS NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7654184 ↗
• InjuryMar 28, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A TECNIS SYMFONY INTRAOCULAR LENS (MODEL ZXT300, +12.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S OPERATIVE EYE IN SECONDARY PROCEDURE BECAUSE PATIENT WAS EXPERIENCING INTOLERABLE RINGS. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT 1 DAY POST OP , THE PATIENT WAS NOTING GLARE AND HALOS. IN ORDER TO CORRECT THE PATIENT'S VISION TO 20/20, A SPECTACLE PRESCRIPTION OF +.37-1.75 X 40 WAS REQUIRED. THE DOCTOR COMMENTED THAT THE SYMFONY LENS HAD MOVED APPROXIMATELY 20 DEGREES FROM POSITION AT THE END OF SURGERY. ALSO, THIS WAS A MYOPIC OUTCOME AS DOCTOR WAS AIMING FOR PLANO. DOCTOR WAITED FOR FULL HEALING AND DESPITE SPECTACLE CORRECTION, THE PATIENT¿S SYMPTOMS OF INTENSE HALOS PERSISTED AND EXPLANT WAS PERFORMED. THE LENS WAS REPLACED WITH A NON-J&J LENS. NO INCISION ENLARGEMENT, AND NO PATIENT INJURY WAS REPORTED. PATIENT WAS IN STABLE CONDITION WHEN DISCHARGED. NO FURTHER INFORMATION REPORTED.

  Patient problems: Halo; No Code Available

  MAUDE report 7380077 ↗
• InjuryMay 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT300 12.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A FEMALE PATIENT'S RIGHT EYE DUE TO OVER CORRECTION OF THE PATIENT'S ASTIGMATISM. THE LENS WAS REPLACED WITH A MODEL ZXT150 11.5 DIOPTER IOL. THROUGH FOLLOW-UP IT WAS LEARNED THAT THE PATIENT IS IMPROVING FROM DAY ONE POST-OP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6574546 ↗