TECNIS IOL ZXT150 (REF ZXT150U115)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474605039), received between Jan 9, 2018 and Sep 21, 2021 — classified as 7 injuries.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE AS THE LENS WAS MISPOWERED. THE PATIENT HAD SLIGHT BLURRINESS. ANOTHER LENS OF SAME MODEL BUT OF DIFFERENT DIOPTER WAS IMPLANTED. THERE WAS NO PATIENT INJURY REPORTED AND NO OTHER INTERVENTION WAS REQUIRED. THE PATIENT WAS REPORTEDLY DOING FINE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 12510944 ↗
• InjuryAug 20, 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 LEFT EYE DUE TO PATIENT COMPLAINING OF DYSPHOTOPSIA. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. ANOTHER JOHNSON & JOHNSON LENS (DIU225 DIFFERENT MODEL AND SAME DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Visual Disturbances

  MAUDE report 12351430 ↗
• InjuryJun 25, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A POST-OPERATIVE EXAMINATION, THERE WAS A MECHANICAL COMPLICATION WITH AN INTRAOCULAR LENS (IOL) IMPLANTED INTO THE PATIENT LEFT EYE. THE PATIENT'S PRE- AND POST-OP VISUAL ACUITY WAS REPORTED AS 20/25 FOR THE LEFT EYE. AN EXPLANT OF THE INTRAOCULAR LENS IS PLANNED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 8729917 ↗
• InjuryOct 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 11.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO THE PATIENT EXPERIENCING HALOS AT NIGHT WHILE DRIVING, GLARE, AND POOR QUALITY OF VISION OVERALL. THERE WAS AN INCISION ENLARGEMENT MADE AND 1 SUTURE USED, BUT NO VITRECTOMY WAS PERFORMED. THE REPLACEMENT LENS WAS A NON-JOHNSON AND JOHNSON LENS. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Impairment

  MAUDE report 8025982 ↗
• InjuryJul 31, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE ZXT150 +11.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. REPORTEDLY, THE LENS WAS REPOSITIONED ON (B)(6) 2017. THE PATIENT VISITED THE DOCTOR ON (B)(6) 2017, AND COMPLAINED OF PSEUDOPHAKIA OU (BOTH EYES). THE PATIENT IS FRUSTRATED THAT HE CANNOT READ, WHICH IS AFFECTING HIS WORK. HE BOUGHT +1.25 OTC (OVER-THE-COUNTER) GLASSES WITH NO HELP. INTERMEDIATE VISION HAS IMPROVED. DISTANCE VISION OS STABLE; FUZZY OD (RIGHT EYE). ALSO NOTED HALOS. UNCORRECTED VISUAL ACUITY OS: 20/25+2 DISTANCE; J2 NEAR. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNED THAT THE SURGEON IS PLANNING TO EXPLANT THE LENS FROM THE LEFT EYE; NO DATE SET. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS TO RECORD THE LENS IN THE LEFT EYE. A SEPARATE MDR WILL BE FILED FOR THE LENS IN THE RIGHT EYE.

  Patient problems: Halo; No Code Available

  MAUDE report 7737493 ↗
• InjuryFeb 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150, 11.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED AS THE PATIENT WAS UNABLE TO TOLERATE THE MULTIFOCAL LENS. THE LENS WAS EXCHANGED FOR A REGULAR TORIC IOL, MODEL ZCT150 (13.0 DIOPTER). THERE WAS NO INCISION ENLARGEMENT AND NO SUTURES REQUIRED. THERE WAS NO PATIENT POST-OP INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7258513 ↗
• InjuryJan 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 11.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE RIGHT EYE (OS) OF THE PATIENT ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017, DUE TO TORIC POWER WAS OVER CORRECTING. THE LENS WAS REPLACED WITH A ZXR00 12.5, LARGER DIOPTER IOL. IT WAS STATED THAT THERE WERE THREE SUTURES, REASON NOT PROVIDED, AND THE PATIENT HAD INFLAMMATION AFTER THE SURGERY BUT THERE WAS NO INCISION ENLARGEMENT OR VITRECTOMY. THE PATIENT VISION WAS NOT AS GOOD AS EXPECTED POST-OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Inflammation; No Code Available; Visual Disturbances

  MAUDE report 7176871 ↗