TECNIS IOL ZXT300 (REF ZXT300U235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474606456), received between Mar 20, 2017 and Sep 8, 2021 — classified as 7 injuries.

The most frequently reported specific device problem is “Unintended Movement” (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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT THE 6 MONTH UNMASKED STUDY VISIT, THE PATIENT'S VISUAL ACUITY IS UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) 20/25 OD (RIGHT EYE), 20/30 OS (LEFT EYE) AND BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) 20/20 OU (BOTH EYES) WITH THE INTRAOCULAR LENS (IOL). THE PATIENT IS VERY BOTHERED BY HALOS WHILE DRIVING AT NIGHT, EXTREMELY BOTHERED BY MULTIPLE/DOUBLE VISION WHILE DRIVING AND SEEING CLEARLY AT DISTANCE, AND EXTREMELY BOTHERED BY GLARE WHILE DRIVING AFTER DARK. THERE ARE NO PLANS FOR SURGICAL INTERVENTION. MONTH 1 ((B)(6) 2021) VISUAL ACUITY: UCDVA 20/25 OU; BCDVA 20/20 OD, 20/25 OS. PREOPERATIVE ((B)(6) 2021) VISUAL ACUITY: UCDVA 20/50 OD, 20/60 OS; BCDVA 20/25 OD, 20/30 OS. PATIENT HAD BILATERAL LENS IMPLANTS. THIS REPORT CAPTURES THE LENS IMPLANTED IN PATIENTS LEFT EYE. A SEPARATE REPORT WILL BE FILED FOR THE RIGHT EYE.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 12443828 ↗
• InjuryApr 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR WAS PLANNING TO EXPLANT A TECNIS SYMFONY TORIC INTRAOCULAR LENS (IOL), MODEL ZXT300, 23.5 DIOPTER, DUE TO THE PATIENT BEING UNHAPPY OF HALOS AND GLARE ISSUES. THE PATIENT HAS NO CONTRIBUTING MEDICAL HISTORY. IT WAS INDICATED THAT THE EXPLANT WILL BE UPCOMING WITH THE DATE OF SURGERY UNKNOWN AT THE MOMENT. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT HAD A BILATERAL LENS IMPLANT. THIS REPORT IS FOR THE PATIENT'S RIGHT EYE (OD). A SEPARATE REPORT IS BEING FILED FOR THE PATIENT'S LEFT EYE (OS).

  Patient problems: Halo; No Code Available

  MAUDE report 8517528 ↗
• InjuryMar 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS EXPERIENCING HALOS AND GLARE AFTER THE IMPLANTATION OF LENS MODEL, ZXT300 MULTIFOCAL IOL (INTRAOCULAR LENS) INTO THE RIGHT EYE. AS A RESULT, LENS WAS EXPLANTED AND REPLACED WITH NON-JOHNSON AND JOHNSON MONOFOCAL LENS. THE PATIENT'S VISUAL ACUITY PRE-OP WAS REPORTED TO BE +2.50 -2.25 X 13 POST-OP 20/25. AT EXPLANT THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES REQUIRED. PATIENT OUTCOME POST-EXCHANGE IS UNKNOWN, NOT PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8458883 ↗
• InjuryMar 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT300, 23.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED WITH AN INCISION ENLARGEMENT DUE TO UNEXPECTED POST-OP REFRACTION. IT WAS STATED THAT THE PATIENT HAS RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8446210 ↗
• InjuryMay 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT300 (23.5 DIOPTER), INTRAOCULAR LENS (IOL) WAS EXPLANTED OF A FEMALE PATIENT'S RIGHT EYE (OD) AS THE PATIENT WAS MYOPIC, HAD ASTIGMATISM AND WAS INTOLERANT (INCORRECT LENS FOR THE PATIENT). THERE WAS NO INCISION ENLARGEMENT REQUIRED AND NO SUTURE WAS USED. THE LENS WAS REPLACED WITH A MODEL ZXT375 (22.5 DIOPTER) LENS. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6586554 ↗
• InjuryApr 22, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED WITHOUT COMPLICATIONS, IN THE RIGHT EYE OF A (B)(6) MALE PATIENT. FOUR WEEKS POST OPERATION, OR APPROXIMATELY (B)(6) 2017, IT WAS NOTED THAT THE LENS WAS DISLOCATED BY ONE MILLIMETER. MANIFEST REFRACTION: -1.00 +0.75 X140. UCVA (UNCORRECTED VISUAL ACUITY): 20/60. BSCVA (BEST SPECTACLE CORRECTED VISUAL ACUITY): 20/25 -2. REPORTEDLY, THE LENS WAS REPOSITIONED IN A SECONDARY SURGICAL PROCEDURE ON (B)(6) 2017. THE LENS WAS REPORTED BEING PERFECTLY CENTERED. THE PATIENT TOLERATED THE PROCEDURE WELL, AND WAS RETURNED TO THE RECOVERY ROOM IN GOOD CONDITION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6514025 ↗
• InjuryMar 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE OF A (B)(6) YEAR-OLD FEMALE PATIENT. THE LENS WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE BECAUSE THE PATIENT WAS UNHAPPY WITH THE SIDE EFFECTS, HALOS/GLARE AND NIGHT QUALITY VISION. REPORTEDLY, THE LENS WAS CUT OUT AND REPLACED WITH ANOTHER LENS, MODEL AND DIOPTER UNKNOWN. IT WAS REPORTED THAT THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 6416472 ↗