TECNIS IOL ZXT225 (REF ZXT225U170)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474605732), received between Nov 30, 2016 and Apr 8, 2020 — classified as 9 injuries.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BEGAN SEEING HALOS WHEN SHE DRIVES AT NIGHT POST IMPLANTATION OF AN INTRAOCULAR LENS (IOL) IN HER RIGHT EYE LAST YEAR. THE PATIENT WAS IMPLANTED WITH AN IOL IN THE LEFT EYE PRIOR TO THE IMPLANT IN THE RIGHT EYE. THE PATIENT SEES PERFECTLY AND IS VERY HAPPY WITH HER VISION, EXCEPT FOR NIGHT DRIVING. THE PATIENT STATED THE HALOS ARE SO BIG SHE CANNOT SEE THE ROAD. THE HALOS ONLY APPEAR WITH CAR HEADLIGHTS. THE PATIENT CAN DRIVE ON THE FREEWAY; HOWEVER, SHE CANNOT DRIVE ON REGULAR STREETS. THE PATIENT HAS TRIED TO USE YELLOW LENS GLASSES AND SUNGLASSES, BUT NEITHER HAVE HELPED WITH THE HALOS. THROUGH FOLLOW-UP, THE PATIENT REAFFIRMED SHE SEES HALOS WHILE DRIVING ON CITY STREETS AND WHILE LOOKING AT RED LIGHTS. THE PATIENT NOTICED THE HALOS ABOUT A MONTH AFTER SHE HAD HER SECOND EYE (RIGHT EYE) DONE ON (B)(6) 2019. THE PATIENT INDICATED THAT SHE DID NOT DRIVE FOR A WHILE AND ONLY NOTICED THE HALOS WHEN SHE STARTED DRIVING AT NIGHT. THE PATIENT HAD HER 1-YEAR VISIT AND THE SURGEON STATED EVERYTHING LOOKED FINE AND HER EYE PRESSURE IS GREAT. NO OTHER INFORMATION WAS PROVIDED. PATIENT HAD BILATERAL LENS IMPLANTS. THIS REPORT CAPTURES THE LENS IMPLANTED IN

  Patient problems: Halo

  MAUDE report 9936355 ↗
• InjurySep 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A STUDY PATIENT COMPLAINED OF VERY BOTHERSOME HALOS AND MODERATELY BOTHERSOME STARBURSTS CAUSING DIFFICULTY WITH DRIVING POST OPERATIVELY. BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA): 20/20 OD (RIGHT EYE). BEST CORRECTED DISTANCE VISUAL ACUITY 20/10 OS (LEFT EYE). THERE ARE NO PLANS FOR ADDITIONAL TREATMENT. THERE WAS NO REPORTED PATIENT COMPLICATIONS AND/OR RELATED INJURY. NO FURTHER INFORMATION PROVIDED. PATIENT HAD BILATERAL LENS IMPLANTS. THIS REPORT IS FOR THE RIGHT EYE. A SECOND REPORT WILL BE SUBMITTED FOR THE LEFT EYE.

  Patient problems: Halo; No Code Available

  MAUDE report 9096421 ↗
• InjuryAug 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT IMPLANT WITH A MODEL ZXT225 17.0D INTRAOCULAR LENS (IOL) IN HER LEFT EYE (OS). APPROXIMATELY 27 WEEKS POSTOP, THE SUBJECT EXPERIENCED HALOS, A LOT OF GLARE AT NIGHT AND A LACK OF NEAR VISUAL ACUITY. PATIENT'S BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) WAS 20/25. ON (B)(6) 2018, LENS WAS EXCHANGED WITH A 17.5 DIOPTER MODEL ZCT300 IOL AND ISSUES HAVE BEEN RESOLVED WITH THE PATIENT'S BCDVA AT 20/15. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 7783108 ↗
• InjuryJun 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SYMFONY INTRAOCULAR LENS (MODEL ZXT225 +17.0 DIOPTER) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE, DUE TO THE PATIENT EXPERIENCING (B)(6) DYSPHOTOPSIA. REPORTEDLY, THE INCISION WAS ENLARGED TO REMOVE THE LENS. NO VITRECTOMY WAS PERFORMED. A COMPETITOR LENS WAS IMPLANTED AS A REPLACEMENT. THE PATIENT WAS REPORTED DOING WELL POST-SURGERY. THE PRODUCT WAS DISCARDED BY THE SURGERY CENTER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7585872 ↗
• InjuryApr 13, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DUE TO A HYPEROPIC MISS, THE DOCTOR PLANNED TO EXPLANT A TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS WITH A HIGHER SE (SPHERE EQUIVALENT) POWER LENS. ADDITIONAL INFORMATION WAS RECEIVED AND CONFIRMED THAT THE LENS WAS EXPLANTED IN THE SECONDARY PROCEDURE. A MODEL ZXT225, WITH A LARGER DIOPTER OF +20.5, WAS USED AS A REPLACEMENT. REPORTEDLY, THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO OTHER MEDICAL INTERVENTION REQUIRED. PATIENT WAS DOING GOOD AT DISCHARGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7430894 ↗
• InjuryDec 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 17.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 DUE TO MULTIFOCAL INTOLERANCE AND AN ASTIGMATIC ISSUE. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED. THE LENS WAS REPLACED WITH A ZXR00 16.5 DIOPTER IOL. REPORTEDLY, THERE WAS NO PATIENT INJURY POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7148864 ↗
• InjuryAug 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS SYMFONY TORIC INTRAOCULAR LENS (IOL), MODEL ZXT225 17.0 DIOPTER, WAS IMPLANTED INTO THE PATENT'S RIGHT EYE (OD) ON (B)(6) 2016. THE PATIENT HAS NOT BEEN SATISFIED WITH HIS VISUAL OUTCOME. THE PHYSICIAN REPORTS THE PATIENT TOLD HIM THAT HIS VISION, WITHOUT GLASSES, IS BETTER THAN IT WAS PRIOR TO HIS CATARACT SURGERY, HOWEVER HE HAS BEEN UNABLE TO READ WITHOUT GLASSES SINCE SURGERY. THE PHYSICIAN PRESCRIBED BIFOCAL GLASSES. PREOPERATIVELY, THE PATIENT¿S REFRACTION WAS OD: -2.25+2.50X172, VISION WAS 20/30 OU (BOTH EYES), BUT HIS GLARE VISION WAS OD 20/60. THE PATIENT REQUIRED REPOSITIONING OF THIS LENS ON (B)(6) 2017. THE PATIENT WAS EXAMINED BY A SECONDARY PHYSICIAN WHO RECOMMENDED MORE AGGRESSIVE TREATMENT OF HIS OCULAR SURFACE ISSUES, BUT, DESPITE INTERVENTION, THE PATIENT DID NOT EXPERIENCE ANY IMPROVEMENT IN HIS VISION. THE PATENT'S RECENT EXAMINATION ON (B)(6) 2017 REVEALED HIS UNCORRECTED VISUAL ACUITY WAS 20/60 AT DISTANCE AND 20/100 AT NEAR, WITH A REFRACTION OF PLANO +1.00X155 +1.75 ADD. HIS VISION WAS 20/30 AT DISTANCE AND 20/20 AT NEAR. FURTHER INFORMATION WAS PROVIDED BY THE PHYSICIAN. HE STATED THAT TO HIM THE PATIENT HAS ACCEPTABLE DISTANCE

  Patient problems: No Code Available

  MAUDE report 6817861 ↗
• InjuryDec 11, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THAT A ZXT225 17.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A FEMALE PATIENT''S LEFT EYE. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6165566 ↗
• InjuryNov 30, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 17.0 DIOPTER INTRAOCULAR (IOL) WAS EXPLANTED FROM A FEMALE PATIENT'S RIGHT EYE DUE TO DISSATISFACTION WITH THE SURGERY OUTCOME. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES REQUIRED. THERE WAS NO PATIENT POST-OP INJURY. THE LENS WAS REPLACED WITH A ZXT225 18.0 DIOPTER IOL.

  Patient problems: No Code Available

  MAUDE report 6134111 ↗