TECNIS IOL ZXT225 (REF ZXT225U205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05050474605800), received between Jun 29, 2017 and Aug 31, 2022 — classified as 14 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2022Adverse 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 A PATIENT'S LEFT EYE IN A SECONDARY SURGICAL PROCEDURE DUE TO DYSPHOTOPSIA WHICH WAS OBSERVED AFTER THE INSERTION OF THE IOL. THE DAILY ACTIVITIES OF THE PATIENT WERE NOT SIGNIFICANTLY AFFECTED. THERE WAS NO INCISION ENLARGEMENT REQUIRED. THE PATIENT OUTCOME WAS NOT PROVIDED. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: Visual Disturbances

  MAUDE report 15332543 ↗
• InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CAPSULE OF PATIENT'S LEFT EYE RUPTURED AFTER THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO IT. THE LENS WAS REMOVED AND VITRECTOMY WAS PERFORMED. ANOTHER LENS OF DIFFERENT MODEL AND DIOPTER (20.0D) WAS USED AS THE REPLACEMENT. NO INFORMATION ON THE PATIENT OUTCOME WAS PROVIDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 15090141 ↗
• InjuryOct 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT HE HAD THE SYMFONY INTRAOCULAR LENSES (IOLS) IMPLANTED IN BOTH EYES. RIGHT AFTER SURGERY, HE INFORMED HIS DOCTOR THAT THE GLARE AND HALOS ARE BOTHERING HIM. HE CANNOT SEE DISTANT OR NEARBY. HE WAS INFORMED THAT HE WILL NOT NEED TO WEAR GLASSES AFTER HAVING THE LENSES IN PLACE. HOWEVER, HE NOW OWN THREE PAIR OF GLASSES. HE CANNOT SEE THE STREET SIGNS WHEN DRIVING, INCLUDING DRIVING AT NIGHT. HE COULD NO LONGER DO HIS DAILY ACTIVITIES BECAUSE THE BRIGHTNESS (DAY LIGHT) IS HARD ON HIS EYES. HE CAN NO LONGER GO FISHING WITH HIS WIFE AND CANNOT DO MOST ACTIVITIES THAT THEY ONCE ENJOYED. IT WAS STATED LATER ON THAT THE DOCTOR PERFORMED LASIK ON THE LEFT EYE FIRST AND THE HALOS WENT AWAY. SUBSEQUENTLY, LASIK PROCEDURE WAS DONE ON THE RIGHT (OD) AS WELL, BUT THE RIGHT EYE HAS NOT IMPROVED. HE HAD USED EYE DROPS, BUT IT DID NOT HELP. HE DOES NOT KNOW THE NAME MAYBE "VISINE". THE DOCTOR ALSO PRESCRIBED A TYPE OF STEROID, BUT HE DOES NOT HAVE THE INFORMATION. HE THEN FOLLOWED UP WITH TWO OTHER PHYSICIANS. THEY BOTH TOLD HIM THAT IT COULD BE DANGEROUS TO HAVE THE LENS REMOVED FROM HIS RIGHT EYE. IT SEEMED THAT THE LENS ALLOWS TOO MUCH LIGHT GOING THROUGH AND THAT MAY

  Patient problems: Blurred Vision; Halo; Visual Impairment

  MAUDE report 12652774 ↗
• InjuryApr 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE RIGHT EYE (OD) DUE TO THE PATIENT COMPLAINED ABOUT BLURRY VISION SINCE THE INCORRECT LENS WAS USED. DOCTOR ADMITS USING THE INCORRECT LENS. THE SURGEON USED A ZXR00 AS A BACKUP LENS. LENS WAS DISCARDED.

  Patient problems: Blurred Vision

  MAUDE report 11671457 ↗
• InjuryOct 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THE IOL WAS EXPLANTED DUE TO COMPLAINTS OF HALO AND GLARE. IT WAS REPORTED HALO AND GLARE SYMPTOMS WERE OBSERVED 1-DAY POST-OP AND AFFECT NORMAL DAILY ACTIVITIES. THERE WERE NO COMPLICATIONS, NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO UNPLANNED SUTURE(S), AND NO VITRECTOMY. LENS WAS DISPOSED AND IS NOT BEING RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 10759310 ↗
• InjuryJan 2, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT SYMFONY TORIC INTRAOCULAR LENS WAS SURGICALLY REPOSITIONED AS THERE WAS TORIC ROTATION BY 12 DEGREE FROM 170. THE PATIENT EXPERIENCED BLURRY VISION. VISUAL ACUITY PRE-OP 20/50-1. REPORTEDLY THERE IS NO PLANNED EXPLANT, NO VITRECTOMY, AND NO INCISION ENLARGEMENT OR SUTURE WERE REQUIRED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9542124 ↗
• InjuryJan 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS (MODEL ZXT225 +20.5 DIOPTER) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE BECAUSE OF THE PATIENT EXPERIENCING DYSPHOTOPSIA. REPORTEDLY, A ZCT300 LENS (DIOPTER UNKNOWN) WAS USED AS A REPLACEMENT FOR THE PATIENT. THERE WAS NO PATIENT INJURY, NO COMPLICATIONS. PATIENT DID WELL POST OPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT THE AFFECTED EYE WAS THE RIGHT EYE (OD), THOUGH THE PATIENT WAS EXPERIENCING BLURRINESS/GLARE WITH THE LEFT EYE TOO. THE ACCOUNT COMMENTED THAT THE SURGEON WILL SEE IF THE LENS EXCHANGE IN THE RIGHT EYE WILL HELP ADJUST THE LEFT EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8226285 ↗
• InjuryNov 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 20.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT EXPERIENCED BLURRY VISION AND HALOS. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS A MODEL ZCT300 21.5 DIOPTER LENS. THE PATIENT IS REPORTED TO BE DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 8097949 ↗
• InjuryNov 9, 2018Scratched Material; Scratched Material

  IT WAS REPORTED THAT A ZXT225 20.5 DIOPTER LENS WAS INSERTED AND THEN REMOVED FROM THE PATIENT'S LEFT EYE DURING THE SAME PROCEDURE BECAUSE A SCRATCH WAS NOTICED AFTER BEING IMPLANTED. AN INCISION ENLARGEMENT WAS PERFORMED AND THE LENS WAS REMOVED AND THEN REPLACED WITH THE SAME MODEL AND DIOPTER LENS. THERE WAS NO VITRECTOMY PERFORMED AND NO SUTURES USED. REPORTEDLY, THE SURGEON BELIEVES THE TECH LOADED THE LENS WRONG. THE LENS WAS DISCARDED BY THE SURGERY CENTER AND THEREFORE NOT AVAILABLE FOR EVALUATION. THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8057602 ↗
• InjuryApr 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 20.5 DIOPTER INTRAOCULAR LENS WAS EXPLANTED ON (B)(6) 2018 FROM A PATIENT WHO HAS FUCHS DYSTROPHY. REPORTEDLY, THE DOCTOR BELIEVES THE ISSUE AS HE SEES IT IS THAT THE PATIENT HAS FUCHS DYSTROPHY. ALSO, THE PATIENT'S IMPLANTED LENS WAS IMPLANTED BY A DIFFERENT DOCTOR THAN THE ONE THAT'S GOING TO EXPLANT THE LENS. THE REPLACEMENT LENS WAS A PCB00 24.0 DIOPTER LENS AND THE PATIENT IS DOING WELL AND IS VERY HAPPY WITH VISION THAT IS MUCH BETTER AS FAR AS GLARE/HALO. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7453011 ↗
• InjuryApr 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S CAPSULAR BAG TORE UPON INSERTION OF A ZXT225 20.5 DIOPTER INTRAOCULAR LENS (IOL) AND THAT THE LENS FELL INTO THE VITREOUS. THEREFORE, THE LENS WAS REMOVED AND REPLACE DURING THE SAME SURGICAL PROCEDURE ON (B)(6) 2018. AN INCISION ENLARGEMENT WAS MADE, BUT NO VITRECTOMY AND NO SUTURES WERE NEEDED. THERE WAS NO PATIENT INJURY AND THE PATIENT'S VISUAL ACUITY WAS 20/70 WITH NO DISCOMFORT AT THEIR ONE DAY POST-OPERATIVE VISIT WITH THE DOCTOR. THE REPLACEMENT LENS WAS MODEL AR40E PLACED IN THE SULCUS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; No Code Available

  MAUDE report 7404335 ↗
• InjuryOct 31, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL), MODEL ZXT225 IMPLANTED, THE DOCTOR NOTICED A HOLE IN THE CAPSULE. THE LENS WAS REMOVED AND REPLACED WITH A 3-PIECE LENS. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 6989545 ↗
• InjuryAug 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A TECNIS SYMFONY TORIC INTRAOCULAR LENS (IOL), MODEL ZXT225 20.5 DIOPTERS, IMPLANTED INTO THE OPERATIVE EYE. PATIENT COMPLAINS OF NO EXTENDED RANGE OF VISUAL ACUITY FROM 28 TO 34 INCHES, RINGS, BLURRING AND CLOUDING OF HER RANGE OF VISUAL ACUITY, DAYTIME GLARE, AND NIGHT TIME HALOS. ALSO, THERE MAY BE A POSSIBLE EXPLANT. NO ADDITIONAL INFORMATION IS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 6804817 ↗
• InjuryJun 29, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A MODEL ZXT225 20.5 DIOPTER INTRAOCULAR LENS WAS EXPLANTED DUE TO THE PATIENT NOT BEING HAPPY WITH THE OUTCOME. THE LENS WAS REPLACED WITH THE SAME MODEL, A 21.0 HIGHER DIOPTER LENS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6679762 ↗