TECNIS IOL ZXT300 (REF ZXT300U200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05050474606388), received between Jul 20, 2017 and Sep 1, 2022 — classified as 11 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 1, 2022Unstable; Unstable

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE DUE TO A MYOPIC SURPRISE AND THE IOL ROTATED 25 DEGREES. THE SURGEON PLANNED ON REPLACING IT WITH ZXT300 19.5. HOWEVER; THE REPLACEMENT LENS WAS NOT CONFIRMED. REPORTEDLY, THERE WERE NO COMPLICATIONS SUCH AS CAPSULE TEAR OR VITRECTOMY. SUTURES WERE NOT REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 15342471 ↗
• InjuryJun 18, 2021Unstable; Unstable

  IT WAS INITIALLY REPORTED THAT AN INTRAOCULAR LENS (IOL) WILL BE EXPLANTED FROM LEFT EYE DUE TO THE PATIENT UNHAPPY WITH THE RESULTS. VISION IS VERY BLURRY IN THE LEFT EYE. LENS IS WELL CENTERED, BUT PATIENT'S VISION HAS NOT IMPROVED. FURTHER INFORMATION WAS PROVIDED THAT THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER JOHNSON & JOHNSON LENS ZXR00 23.5 (DIFFERENT MODEL AND HIGHER DIOPTER). THERE WAS NO PATIENT POST-OP INJURY AND NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT OUTCOME REPORTED VISION IS STILL VERY FUZZY, PATIENT IS NOT HAPPY, AND THE LENS ROTATED AND FLIPPED AXIS. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 12026301 ↗
• InjuryJul 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT300 INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENTS RIGHT EYE. THE IOL WAS EXPLANTED AS THE PATIENT NEEDED A DIFFERENT TORIC POWER, AND REPLACED WITH A NON-JOHNSON AND JOHNSON IOL. THE PATIENT WENT FROM A MULTIFOCAL, TORIC IOL TO A NON-MULTIFOCAL IOL. THERE WAS NO ADDITIONAL INTERVENTION PERFORMED AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8849213 ↗
• InjuryJun 14, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S VISION BECAME ALTERED WHEN THE ZXT300 INTRAOCULAR LENS (IOL) BECAME DECENTERED AND THE PATIENT WANTED IT REMOVED. THE PATIENT CHOSE TO WAIT APPROXIMATELY ONE MONTH BEFORE HAVING THE LENS REMOVED. THE PHYSICIAN WHO PERFORMED THE EXPLANT WAS DIFFERENT FROM THE ONE THAT IMPLANTED THE IOL. THE PATIENT WAS DOING FINE AFTER THE EXPLANT. A VITRECTOMY WAS REQUIRED; BUT IT WAS UNKNOWN IF AN INCISION ENLARGEMENT OR SUTURES WERE REQUIRED. NO ADDITIONAL INFORMATION WAS RECEIVED. PRE-OP VISUAL ACUITY: 20/200. POST-OP VISUAL ACUITY: 20/70 WITHOUT CORRECTION.

  Patient problems: No Code Available; Visual Disturbances; Vitrectomy

  MAUDE report 8701613 ↗
• InjuryMar 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE ZXT300 +20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE ON (B)(6) 2019. REPORTEDLY, THE PATIENT EXPERIENCED GLARE AT NIGHT THAT AFFECTED HER DRIVING ABILITIES. THE INCISION WAS ENLARGED AND THE LENS WAS EXPLANTED. NO VITRECTOMY WAS PERFORMED AND NO SUTURES WERE USED. UPON FURTHER FOLLOW-UP IT WAS LEARNT THAT THE LENS WAS NOTICED DISPLACED INFERIORLY AT THE (SLIT LAMP EXAM) SLE, BUT LOOKED CENTERED IN THE OPERATING ROOM (OR). DURING SURGERY, THE IOL WAS ELEVATED, CUT AND REMOVED. A NON-JOHNSON & JOHNSON LENS WAS IMPLANTED AS A REPLACEMENT VIA OPTIC CAPTURE AND REMAINED CENTERED POST-OP. AFTER ONE WEEK THE PATIENT WAS 20/25 WITHOUT CORRECTION AND WITHOUT ANY COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8415828 ↗
• InjuryMar 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT300 20.0 DIOPTER MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO THE PATIENT EXPERIENCING NIGHT TIME VISUAL DISTURBANCES AND A MILD SPIDER WEBBING EFFECT AROUND LIGHT SOURCES POST-OPERATIVELY. VISUAL ACUITY POST-OP WAS NOTED AS -.5D SPHERE. THE PATIENT WAS ENCOURAGED TO NUERO-ADAPT BUT COULD NOT TOLERATE AND REQUESTED AN EXPLANT. THE LENS WAS EXPLANTED AND REPLACED WITH A MONOFOCAL IOL. THE PATIENT IS EXPERIENCING GOOD VISION AND MOST COMPLAINTS HAVE STOPPED. THE EXPLANTED LENS IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 8402620 ↗
• InjuryOct 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS (MODEL ZXT300, +20.0 DIOPTER) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE BECAUSE OF PATIENT EXPERIENCING DOUBLE VISION. THERE WAS NO PATIENT INJURY. REPORTEDLY A MODEL ZCT450 AND +21.0 DIOPTER WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8003004 ↗
• InjuryMar 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGERY CENTER REPORTED THAT DOCTOR INSERTED A ZXT300 20.0 DIOPTER INTRAOCULAR LENS (IOL) WHEN HE NOTICED THAT THE CAPSULAR BAG WAS WEAK AND HAD TO TAKE THE LENS OUT. IT WAS NOTED THAT THERE WAS NO PRODUCT QUALITY ISSUE. IN FOLLOW UP, IT WAS REPORTED THAT THERE WAS A CAPSULE TEAR AND A VITRECTOMY WAS PERFORMED AFTER THE LENS WAS USED. THE LENS WAS REMOVED AND A REPLACEMENT LENS FROM ANOTHER MANUFACTURER WAS USED DURING THE SAME SURGERY. THERE WAS NO INCISION ENLARGEMENT PERFORMED AND NO OTHER MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. REPORTEDLY, THERE WAS NO PATIENT POST-OP INJURY; THE PATIENT OUTCOME WHEN DISCHARGED WAS GOOD AND MET THE STANDARD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 7314986 ↗
• InjurySep 15, 2017Adverse Event Without Identified Device or Use Problem; Unintended Movement; Adverse Event Without Identified Device or Use Problem; Unintended Movement

  IT WAS REPORTED THAT A MULTIFOCAL TORIC INTRAOCULAR LENS (MODEL ZXT300, +20.0 DIOPTER) WAS EXPLANTED FROM THE LEFT EYE OF A FEMALE PATIENT. THE REASON FOR THE EXPLANT WAS NOT PROVIDED. ANOTHER TORIC LENS WAS IMPLANTED AS A REPLACEMENT, MODEL AND DIOPTER UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6870796 ↗
• InjuryAug 28, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A TECNIS SYMFONY TORIC INTRAOCULAR LENS (IOL), MODEL ZXT300 20.0 DIOPTER, WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO ''BREAKDOWN OF THE IOL''. THERE WAS NO WOUND ENLARGEMENT, COMPLICATIONS, OR SUTURES USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6826178 ↗
• InjuryJul 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT300 20.0 DIOPTER INTAOCULAR LENS (IOL) WAS EXPLANTED AND REPLACED WITH A DIFFERENT MODEL LENS FROM A MALE PATIENT''S LEFT EYE.

  Patient problems: No Code Available

  MAUDE report 6730750 ↗