TECNIS IOL ZXT150 (REF ZXT150U145)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05050474605091), received between Jun 9, 2017 and Sep 28, 2020 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT'S VISION IN THE LEFT EYE IS NOT SHARP LIKE THERE IS A FILM OR A CLOUD OVER THE LENS. THE PATIENT ALSO SEES HALOS AND SPARKLES THAT INTERFERE WITH NIGHT DRIVING. THE OPHTHALMOLOGIST PROVIDED EYE DROPS AND TO GIVE IT FIVE WEEKS. THE PATIENT'S VISION DID NOT IMPROVE, AND SHE IS HAVING TO WEAR GLASSES FOR BOTH DISTANT AND NEAR VISION. THE PATIENT'S EYE TESTS AND EYE HEALTH ARE FINE. THROUGH FOLLOW-UP, THE PATIENT SAW HER SURGEON ON (B)(6) 2020 AND HAD LASER TREATMENT PERFORMED TO GET THE FILM OFF HER EYE. THE PATIENT COMPLAINED THAT SHE STILL CANNOT SEE CLEAR, AND THE LASER DID NOT HELP AT ALL. THE PATIENT WAS SENT TO GET PRESCRIPTION GLASSES WHICH HELP, HOWEVER, PATIENT COMPLAINS CANNOT SEE CLOSE WITHOUT THE GLASSES. THE OPTOMETRIST STATED THE PATIENTS EYE LOOKS FINE AND PRESSURE IS FINE. AT THIS TIME, THE LENS REMAINS IMPLANTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 10597520 ↗
• InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZXT150 14.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2019. THE LENS WAS EXPLANTED (B)(6) 2019 DUE TO COMPLAINTS OF BLURRY/FUZZY VISUAL ACUITY (VA). THERE WERE NO SERIOUS PATIENT INJURIES OR COMPLICATIONS REPORTED AT EXPLANT. ONE-DAY POST-OP RESULTS WERE REPORTED AS 20/40 J10. ZXT150 LENS WAS REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION CRYSTALLINE LENS. THE ZXT150 LENS IS NOT BEING RETURNED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8952578 ↗
• InjuryAug 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZXT150 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO RESIDUAL REFRACTIVE ERROR. AT EXPLANT THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES REQUIRED. THE LENS WAS REPLACED WITH A NON-JOHNSON AND JOHNSON LENS. THE PATIENT WAS STATED TO BE FINE POST-OP, AND THE EXPLANTED LENS WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8886371 ↗
• InjuryJun 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO THE PATIENT EXPERIENCING DYSPHOTOPSIA THE TYPE WAS NOT PROVIDED. REPORTEDLY, THE DYSPHOTOPSIA SIGNIFICANTLY INTERFERED WITH THE PATIENT'S DAILY ACTIVITIES. THERE WAS NO INCISION ENLARGEMENT AND THERE WAS NO REPORT OF ANY PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Blurred Vision; Halo; No Code Available; Visual Disturbances

  MAUDE report 8665127 ↗
• InjuryFeb 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZXT15 14.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S LEFT EYE (OS) ON (B)(6) 2018. PATIENT REPORTED EXPERIENCING HALOS AND THE LENS WAS EXPLANTED ON (B)(6) 2019. IT WAS REPORTED THE LENS WAS REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION AND THE ZXT150 IOL WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Halo; No Code Available

  MAUDE report 8368809 ↗
• InjuryJan 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED. THE REASON FOR EXPLANT WAS DUE TO HALOS AND PATIENT HAD DIFFICULTY DRIVING AT NIGHT. SYMPTOMS BEGAN ONE MONTH POST-OP. THE REPLACEMENT LENS WAS A MONOFOCAL LENS, A MODEL ZA9003. PATIENT DOING WELL AT ONE WEEK POST OP. VISUAL ACUITY WAS 20/20. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8262847 ↗
• InjuryNov 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZXT150, 14.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2018 DUE TO PATIENT COMPLAINT OF BLURRINESS AT ALL DISTANCES SINCE (B)(6) 2018, PHACO OS SURGERY. MANIFEST REFRACTION WAS REPORTED AS -0.75 +0.75X120=2/25- ON (B)(6) 2018. THERE WAS NO OTHER MEDICAL INTERVENTION REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8076497 ↗
• InjuryAug 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS (MODEL ZXT150, +14.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S OPERATIVE EYE BECAUSE PATIENT WAS UNHAPPY WITH GLARES AND HALOS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 7779686 ↗
• InjuryOct 25, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZCT150 14.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 BECAUSE THE PATIENT DID NOT GET ENOUGH NEAR VISION. THERE WAS NO INCISION ENLARGEMENT PERFORMED. THE LENS WAS REPLACED WITH THE SAME MODEL, BUT DIFFERENT DIOPTER OF 14.0. REPORTEDLY, THE PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6975443 ↗
• MalfunctionJul 21, 2017Torn Material; Torn Material

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT''S EYE AND IT WAS REMOVED, DURING THE SAME SURGICAL PROCEDURE, BECAUSE IT WAS TORN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6730881 ↗
• InjuryJun 9, 2017Adverse 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 RIGHT EYE OF A (B)(6) MALE PATIENT, BECAUSE THE PATIENT WAS NOT HAPPY WITH THEIR VISION. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE PATIENT HAD EXCELLENT DISTANCE VISION AND GOOD NEAR VISION. HOWEVER HE WAS EXPERIENCING HALOS AND GLARE DURING THE DAY AND AT NIGHT TIME. REPORTEDLY, THE SYMPTOMS DID NOT IMPROVE WITH A TRIAL OF PILOCARPINE 1% DROPS. THE PATIENT WAS REPORTED AS STILL RECOVERING FROM THE LENS EXCHANGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 6629970 ↗