TECNIS IOL ZXT225 (REF ZXT225U195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05050474605787), received between Nov 3, 2017 and Nov 17, 2023 — classified as 12 injuries.

The most frequently reported specific device problem is “Unstable” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S RIGHT EYE DUE TO GLARE AND HALOS. THE PATIENT¿S SYMPTOMS PERSISTED FOR THREE (3) MONTHS. ANOTHER JOHNSON & JOHNSON LENS OF DIFFERENT MODEL (DIU225) AND LOWER DIOPTER (+18.5) WAS USED AS A REPLACEMENT. THERE WAS NO VITRECTOMY REQUIRED AND NO SUTURES USED. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 18164572 ↗
• InjuryJan 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OCULAR SINISTER (LEFT EYE). THE IOL WAS EXPLANTED IN A SEPARATE SURGICAL PROCEDURE DUE TO COMPLAINTS OF FUZZY NEAR VISION OBSERVED POST-OPERATIVE (OP) DAY 1 AND BY POST-OP DAY 10 FUZZY NEAR VISION WAS WORSE. THE EXPLANTED IOL WAS REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION LENS. THERE WAS NO COMPLICATIONS, SUCH AS CAPSULAR TEAR, NO UNPLANNED INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO UNPLANNED SUTURE(S), AND NO UNPLANNED VITRECTOMY. PATIENT OUTCOME POST LENS EXCHANGE WAS REPORTED AS NO POSTOPERATIVE COMPLICATIONS AND PATIENT'S VISION IS GOOD AT BOTH NEAR AND DISTANCE. PRODUCT IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 13339183 ↗
• InjuryJan 9, 2021Unstable; Unstable

  THE ACCOUNT REPORTED OF A 40 DEGREE ROTATION OF AN INTRAOCULAR LENS (IOL) IN THE LEFT EYE OF A PATIENT. THE REPOSITION OF THE LENS WAS PERFORMED ON (B)(6) 2020 AND REPORTEDLY THE PATIENT IS DOING VERY WELL. NO FURTHER INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11143971 ↗
• InjuryJan 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING BLURRY VISION IMMEDIATELY POST-OP AND WORSENING WITH AN INTRAOCULAR LENS (IOL). THE LENS WAS EXPLANTED AND THE INCISION WAS ENLARGED, HOWEVER, THERE WAS NO OTHER MEDICAL OR SURGICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 11137941 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD SYMFONY TORIC INTRAOCULAR LENS (IOL) IMPLANTED IN HER LEFT EYE (OS) BUT IS UNHAPPY WITH HER VISION BECAUSE SHE IS BLURRY AT ALL DISTANCES. NEVERTHELESS, THE DOCTOR IS NOT EXPLANTING THE IOL. IT WAS LEARNED THAT VISUAL ACUITY NEAR: J5 BLURRY, INTERMEDIATE OS 20/50. DISTANCE OS. 20/-30. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 10926198 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT HE UNDERWENT BILATERAL ZXT225 INTRAOCULAR LENS (IOLS) IMPLANTS. THIS REPORT CAPTURES THE EVENT FOR THE RIGHT EYE. THE LEFT EYE IOL WAS RE-ALIGNED BY THE DOCTOR POST IMPLANT, BUT THE PATIENT IS STILL HAVING SYMPTOMS (NO DATE OF THE REALIGNMENT WAS PROVIDED). THE PATIENT CONSULTED HIS DOCTOR ABOUT THE ISSUES AS HE IS STILL UNHAPPY. PATIENT IS ALSO CONSIDERING OBTAINING A SECOND OPINION. THROUGH FOLLOW-UP THE PATIENT CLARIFIED HIS VISION IS FINE EXCEPT FOR HALOS AND GLARES WHICH MAKES HIM UNCOMFORTABLE. HE ALSO REPORTS SEEING BRIGHT FLASHES DURING THE DAY WHEN LOOKING AT LIGHT, AND HALOS WHILE WATCHING TELEVISION. HE HAS AN ACTIVE LIFE AND NOW HE FEELS RESTRICTED BECAUSE OF HIS VISUAL ISSUES. HIS DOCTOR SUGGESTED THAT HE WAIT A WHILE AS HIS BODY MUST ADAPT TO THE IMPLANTS. BUT THE PATIENT FEELS HIS VISUAL ISSUES ARE GETTING WORSE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 9521940 ↗
• InjuryJul 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED HAVING BILATERAL IMPLANTS IN (B)(6) 2017 AND IS SEEING HALOS AND STARBURST AROUND THE LIGHTS. THE PATIENT ALSO SEE' SHADOW LINES WHICH HER DOCTOR INFORMED HER THAT SHE IS SEEING THE RIDGES ON THE LENS. THE PATIENT HAS BEEN SEEING HER DOCTOR EVERY SIX MONTHS. AT THIS TIME, THE LENS REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT REPRESENT THE LENS IMPLANTED IN PATIENTS LEFT EYE.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 8790786 ↗
• InjuryDec 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE MULTIFOCAL ZXT225 19.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2017. THE LENS WAS EXPLANTED ON (B)(6) 2018 DUE TO THE PATIENT BEING UNABLE TO TOLERATE HALOS, GLARE, AND SPOKING. A MONOFOCAL LENS (MODEL AND DIOPTER UNKNOWN) WAS IMPLANTED AS A REPLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Halo; No Code Available

  MAUDE report 8157981 ↗
• InjuryNov 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZXT225 19.5 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT COMPLAINED OF HALOS, GLARE, AND STARBURSTS AT NIGHT. THE INCISION WAS ENLARGED TO REMOVE THE LENS BUT THERE WERE NO COMPLICATIONS AND NO PATIENT INJURY. THE REPLACEMENT LENS WAS A ZCT225 20.0 DIOPTER. REPORTEDLY, THE EXPLANTED LENS WAS DISCARDED BY THE ACCOUNT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8098545 ↗
• InjuryMar 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 19.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE OF AN UNEXPECTED POST-OPERATIVE REFRACTION. THERE WAS NO INCISION ENLARGEMENT PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7364337 ↗
• InjuryDec 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MULTIFOCAL TORIC INTRAOCULAR LENS (MODEL ZXT225, +19.5 DIOPTER) WAS EXPLANTED IN A SECONDARY PROCEDURE BECAUSE OF THE PATIENT WAS NOT SATISFIED WITH THE REFRACTIVE RESULTS. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE INCISION WAS ENLARGED AND THE LENS WAS REPLACED WITH A NON-AMO LENS. THE PATIENT IS WAS DOING GOOD POST EXCHANGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7103014 ↗
• InjuryNov 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 19.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017, DUE TO PATIENT COMPLAINING OF A POSITIVE FLICKER. THE MOST RECENT REFRACTION PRIOR TO EXPLANT WAS -0.75 X +0.75 X 50. REPORTEDLY, THE IMPLANTING DOCTOR TRIED TO TALK THE PATIENT OUT OF IMPLANTING A SYMFONY IOL BECAUSE OF HER ISSUES WITH DRY EYE. THE DOCTOR TRIED A PUNCTAL PLUG IN THE PATIENT'S OPERATIVE EYE PRIOR TO SURGERY, BUT IT WAS REMOVED BECAUSE THE PATIENT SAID IT WAS UNCOMFORTABLE. THE REPLACEMENT LENS WAS A NON-AMO LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7000965 ↗