TECNIS IOL ZXT300 (REF ZXT300U140)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474606265), received between Feb 10, 2017 and Dec 11, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Scratched Material” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZXT300 14.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OCULAR DEXTER (RIGHT EYE) IN A SECONDARY SURGICAL PROCEDURE DUE TO POOR VISION. A DIFFERENT LENS, MODEL DIU300 OF 14.0 DIOPTER WAS USED AS THE REPLACEMENT. THERE WERE NO COMPLICATIONS, SUCH AS CAPSULAR TEAR, INCISION ENLARGEMENT, SUTURE(S) AND/OR VITRECTOMY REPORTED. PATIENT OUTCOME POST-LENS EXCHANGE WAS GOOD, AND NO SERIOUS INJURY REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 15956434 ↗
• InjuryFeb 3, 2020Adverse 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 OPERATIVE EYE DUE TO A MISSED REFRACTION. THE LENS WAS DISCARDED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT LOWER DIOPTER. THERE WERE NO FURTHER INTERVENTION DURING SURGERY. THE PATIENT IS DOING WELL POST-OPERATIVELY. THE EXPLANTED LENS IS NOT AVAILABLE FOR RETURN AS THE FRAGMENTS WERE DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9663004 ↗
• InjuryOct 9, 2018Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE TECNIS SYMFONY TORIC INTRAOCULAR LENS (MODEL ZCT300 +14.0 DIOPTER) WAS REMOVED AND REPLACED FROM THE PATIENT¿S RIGHT EYE DUE TO A SCRATCH NOTICED ON THE LENS DURING IMPLANTATION. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT DURING THE REMOVAL PROCESS A MINIMAL INCISION ENLARGEMENT WAS PERFORMED AND ONE SUTURE WAS USED. A BACK-UP LENS (SAME MODE AND DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE SUTURE WAS REMOVED ON POST-OP DAY ONE. THE PATIENT WAS REPORTED DOING FINE WHEN DISCHARGED. THE ACCOUNT COMMENTED THAT THE SAMPLE IS NOT AVAILABLE FOR INSPECTION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7947052 ↗
• InjurySep 23, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (MODEL ZXT300, +14.0 DIOPTER) WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE FROM THE LEFT EYE OF A FEMALE PATIENT BECAUSE THE LENS WAS OBSERVED ROTATED POST IMPLANTATION. REPORTEDLY, ANOTHER LENS (MODEL ZXT225, +13.5 DIOPTER) WAS IMPLANTED AS A REPLACEMENT WITHOUT INCIDENTS. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE LENS HAD ROTATED ABOUT 20 DEGREES POST IMPLANTATION. THE SURGEON DECIDED TO PERFORM A LENS EXCHANGE INSTEAD OF A LENS ROTATION. NO SPECIFIC PATIENT ISSUES WERE REPORTED. NO INCISION ENLARGEMENT, NO VITRECTOMY WAS PERFORMED AND NO SUTURES WERE USED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6889115 ↗
• InjuryFeb 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ZXT300 14.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A FEMALE PATIENT'S LEFT EYE DUE TO A MYOPIC AND RESIDUAL ASTIGMATISM. THE LENS WAS REPLACED WITH A THE SAME MODEL LENS OF A LOWER DIOPTER (13.0). THERE WAS NO INCISION ENLARGEMENT OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Code Available

  MAUDE report 6321194 ↗