TECNIS IOL ZXT300 (REF ZXT300U170)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474606326), received between Dec 26, 2017 and Jul 18, 2022 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO WAS GIVEN AN INTRAOCULAR LENS (IOL) IN HIS LEFT EYE, RESULTED WITH A LESS THAN SATISFACTORY RESULT. PATIENT STATED THAT HIS VISION NEVER IMPROVED, IN FACT, HE FELT WORSE. THEREFORE, AN IOL EXCHANGE WAS DONE AND A STANDARD LENS (NON JNJ LENS) WAS IMPLANTED INSTEAD, WITH SUTURES REQUIRED. IT WAS STATED THAT THE PATIENT WAS DOING A LOT BETTER POST-EXPLANT. THE EXPLANTED IOL WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort

  MAUDE report 15046902 ↗
• InjuryJan 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A MODEL ZXT300 17.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2019. THE LENS WAS SUBSEQUENTLY EXPLANTED DUE TO PATIENT COMPLAINT OF HALOS. PATIENT OUTCOME WAS REPORTED AS OKAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 9651272 ↗
• InjurySep 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A STUDY PATIENT COMPLAINED OF VERY BOTHERSOME HALOS AND MODERATELY BOTHERSOME STARBURSTS CAUSING DIFFICULTY WITH DRIVING POST OPERATIVELY. BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA): 20/20 OD (RIGHT EYE) BEST CORRECTED DISTANCE VISUAL ACUITY 20/10 OS (LEFT EYE). THERE ARE NO PLANS FOR ADDITIONAL TREATMENT. THERE WAS NO REPORTED PATIENT COMPLICATIONS AND/OR RELATED INJURY. NO FURTHER INFORMATION PROVIDED. PATIENT HAD BILATERAL LENS IMPLANTS. THIS REPORT IS FOR THE LEFT EYE. A SECOND REPORT WILL BE SUBMITTED FOR THE RIGHT EYE.

  Patient problems: Halo; No Code Available

  MAUDE report 9096422 ↗
• InjuryApr 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT300 17.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. POST-OPERATIVELY, THE PATIENT COMPLAINED OF INTOLERABLE, OVERWHELMING, AND DEBILITATING GLARE, INCLUDING HALOS, CONCENTRIC CIRCLES, AND STARBURSTS. THE PATIENT WAS UNSURE OF WHEN THE ONSET OF THESE SYMPTOMS STARTED; HOWEVER, STATED IT WAS A FEW WEEKS AFTER IMPLANT. REPORTEDLY, THE LENS IS PLANNED TO BE EXPLANTED AND EXCHANGED ON (B)(6) 2018. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENSES IMPLANTED. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE PATIENT'S RIGHT EYE. A SEPARATE REPORT WILL BE FILED FOR THE LEFT EYE.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 7463276 ↗
• InjuryDec 26, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZXT300 17.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE (OS) ON (B)(6) 2017 USING A CAPSULAR TENSION RING (CTR). ONCE THE LENS WAS IN THE CAPSULAR BAG, THE DOCTOR STARTED MOVING THE LENS AROUND AND THE IOL ENDED UP POPPING OUT OF THE CAPSULAR BAG AND CAUSED IT TO TEAR. THE DOCTOR TRIED PERFORMING A REVERSE OPTIC CAPTURE, BUT HE IOL DIDN'T STAY WELL-CENTERED AND HE COULDN'T SUTURE IT INTO GOOD POSITION EITHER. POST-OPERATIVELY, BECAUSE THE LENS DIDN'T STAY CENTERED, THE DOCTOR ATTEMPTED A LENS REPOSITIONING PROCEDURE ON (B)(6) 2017, BUT WAS UNABLE TO KEEP THE LENS CENTERED. ALSO, A PARS PLANA VITRECTOMY WAS PERFORMED AFTER THE LENS REPOSITIONING. THE LENS WAS LATER EXPLANTED ON (B)(6) 2017 AND THE REPLACEMENT LENS WAS A NON-AMO LENS. THERE WAS NO PATIENT INJURY POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; No Code Available; Vitrectomy

  MAUDE report 7145939 ↗