TECNIS IOL ZXT300 (REF ZXT300U160)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474606302), received between Dec 5, 2017 and Aug 5, 2021 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Product Quality Problem” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2021Adverse 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 RIGHT EYE DUE TO POWER MISS. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. SURGERY WAS COMPLETED USING THE SAME MODEL, BUT DIFFERENT DIOPTER (16.5 D) REPLACEMENT LENS. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 12285126 ↗
• InjuryFeb 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS SYMFONY INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT (OD) EYE DUE TO INTOLERABLE BLURRING AND GLARE. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION PERFORMED. THE REPLACEMENT LENS IS A NON-JOHNSON AND JOHNSON LENS. THE CUSTOMER ALSO INDICATED THAT THE LENS HAD BEEN THROWN OUT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 11305851 ↗
• MalfunctionMay 20, 2020Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THERE WERE ANTERIOR DEPOSITS ON LENS OBSERVED WHILE INSERTING LENS INTO THE PATIENT'S RIGHT EYE. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS OF THE SAME MODEL AND DIOPTER IN THE SAME SURGICAL PROCEDURE. THERE WAS NO INCISION ENLARGEMENT REQUIRED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10077584 ↗
• InjuryMay 17, 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. THERE WAS NO INDICATION OF INCISION ENLARGEMENT OR ANY OTHER REQUIRED SURGICAL INTERVENTION. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL, BUT HIGHER DIOPTER) WAS IMPLANTED AS THE REPLACEMENT LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 10064132 ↗
• InjuryFeb 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A MODEL ZXT300 16.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2019. THE LENS WAS EXPLANTED ON (B)(6) 2020 DUE TO COMPLAINT OF ASTHENOPIA, AND REPLACED WITH SAME MODEL BUT LOWER DIOPTER, 15.0. IT WAS REPORTED THERE WERE NO COMPLICATIONS DUE TO THE IOL EXCHANGE, NO SUTURES, AND NO VITRECTOMY WERE REQUIRED. THE EXPLANTED LENS IS NOT RETURNING FOR EVALUATION. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 9674138 ↗
• InjuryAug 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A CAPSULAR BAG BROKE FROM THE PATIENT¿S OPERATIVE EYE. IT WAS REPORTED THAT A ZXT300 INTRAOCULAR LENS (IOL) WAS IMPLANTED & AS THE TEMPORAL HAPTIC WAS BEING PLACED IN THE CAPSULAR BAG IT WAS NOTED THAT THE NASAL HAPTIC WAS FALLING BACK INTO THE VITREOUS CAVITY & THERE WAS VITREOUS PRESENTING AT THE INCISION. THERE WAS INCISION ENLARGEMENT, A VITRECTOMY WAS PERFORMED, & A SUTURE WAS USED, BUT NO PATIENT POST-OP INJURY. THE SURGERY CENTER USED A BACKUP ( BAULSH & LOMB) LENS TO PLACED IN THE OPERATIVE EYE.

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

  MAUDE report 8863899 ↗
• InjuryJan 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ZXT300 16.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S RIGHT EYE ON (B)(6) 2017. ONE DAY POST OP THE DOCTOR NOTES LOTS OF INFLAMMATION. THE SURGEON CONSULTED WITH THE RETINA SPECIALIST, AND THEY BOTH AGREED THAT THIS WAS A CASE OF TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THE PATIENT WAS REPORTED AS HAVING A LARGER PUPIL AND EXPERIENCING GLARE SYMPTOMS. IN ADDITION, THERE WERE SEVERAL FLOATERS IN THE RIGHT EYE (OD), MAYBE (OU) BOTH EYES, BIG IN SIZE, AND BLURRY VISION. THE CONDITION¿S SEVERITY WAS NOTED AS SEVERE. DISTANCE VISION SC (WITHOUT CORRECTION): 20/200 WITH INCREASED STEROID USE. SECOND DAY POST OP SINCE THE AFFECTED AREA DECREASED AND THE PATIENTS VISION BECAME WORSE. NO EYE PAIN WAS EXPERIENCED BY THE PATIENT. DISTANCE VISION SC 20/200. NEAR VISION OD SC 20/200-1. FOURTH DAY POST OP PATIENT REPORTED VISION WAS A BIT BETTER, WITH NO PAIN, TEARING, OR ITCHING. THERE WAS SOME BURNING WHEN APPLYING EYE DROPS. DISTANCE VISION SC 20/200. NEAR VISION OD 20/200-1. TWO-WEEK POST-OP THE PATIENT¿S VISION WAS STABLE. THE CONDITION'S SEVERITY WAS MODERATE. THE PATIENT WAS EXPERIENCING NO EYE PAIN. DISTANCE VISION SC 20/60-1 AND NEAR VISION OD S

  Patient problems: Blurred Vision; Inflammation; Vitreous Floaters

  MAUDE report 7202586 ↗
• InjuryDec 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT300 16.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017, BECAUSE THE PATIENT EXPERIENCED BLURRY VISION AND HAD DIFFICULTY SEEING STREET SIGNS. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED. THE LENS WAS REPLACED WITH A ZXT150 16.0 DIOPTER IOL. REPORTEDLY, THERE WAS NO PATIENT INJURY POST-OPERATIVELY AND THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available; Visual Impairment

  MAUDE report 7085536 ↗