TECNIS IOL ZXT225 (REF ZXT225U225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05050474605848), received between Dec 28, 2016 and May 13, 2021 — classified as 14 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (2 reports).

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

• InjuryMay 13, 2021Adverse 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). IOL WAS EXPLANTED DUE TO COMPLAINTS OF UNEXPECTED POST-OP REFRACTION POST LASIK AND REPLACED WITH A DIFFERENT LENS MODEL WITH A DIFFERENT DIOPTER SIZE. LENS IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. CURRENT PATIENT STATUS WAS REPORTED AS RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 11823184 ↗
• InjuryAug 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 22.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO UNEXPECTED POSTOP REFRACTION WITH MYOPIC OUTCOME. REPORTEDLY, THE PATIENT IS DOING GREAT POST SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8887115 ↗
• InjuryApr 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LENS WAS EXPLANTED DUE TO INTOLERABLE GLARE AND HALOS. THE PATIENT WAS UNHAPPY WITH THEIR VISION POST SURGERY. PATIENT''S VISUAL ACUITY WAS 20/20; IT WAS NOT A VISION ISSUE; BUT A HALOES/GLARE ISSUE. THE LENS WAS REPLACED WITH A TORIC MONOFOCAL, MODEL ZCT225. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8537436 ↗
• InjuryMar 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CALLED TO REPORT HER EXPERIENCE WITH THE INTRAOCULAR LENS (IOL) IMPLANTS. PATIENT UNDERWENT BILATERAL LENS IMPLANTS IN (B)(6) 2018. PATIENT REPORTED SHE STARTED TO HAVE HALOS/GLARES AND CIRCLES AROUND THE LIGHTS WHEN DRIVING AT NIGHT RIGHT AFTER SURGERY. IN THE MORNING, SHE HAD TO WEAR ANTI-GLARE SUNGLASSES BECAUSE OF THE GLARES AND COULD NOT READ UP CLOSE. PATIENT WAS PRESCRIBED PRESCRIPTIVE GLASSES AND WOULD BE PICKING THEM UP THE FOLLOWING WEEK AS HER DOCTOR SAID THAT IT WILL HELP WITH HER VISION. DOCTOR PERFORMED A LASER PROCEDURE ON THE RIGHT EYE TO REMOVE SCAR TISSUE. THE DOCTOR INFORMED THE PATIENT THAT IT WAS TOO SOON TO DETERMINE IF THE CUSTOMER MAY NEED A LENS EXCHANGE AND SHE WAS ADVISED TO WAIT FOR A YEAR BEFORE CONSIDERING LENS EXPLANT(S). PATIENT HAD BILATERAL LENS IMPLANTS; THIS REPORT REPRESENTS THE LENS IMPLANTED IN THE RIGHT EYE. A SEPARATE REPORT WILL BE FILED FOR THE LEFT EYE.

  Patient problems: Halo; No Code Available

  MAUDE report 8427535 ↗
• InjuryFeb 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT HAD BILATERAL INTRAOCULAR LENS (IOL) IMPLANT IN (B)(6) 2018. REPORTEDLY, THE PATIENT EXPERIENCED HALOS, BLURRED VISION AND LINES IN THE HALO. THE RIGHT EYE (OD) IS WORSE THAN THE LEFT (OS). HE STATED THAT HIS DOCTOR DID NOT RECOMMEND AN EXPLANT. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE PATIENT DEVELOPED VISUAL ISSUES RIGHT AWAY POST-OP. THE PATIENT HAS DIFFICULTY DRIVING AT NIGHT DUE TO HALOS. CAN SEE CLOSE-UP BETTER THAN CAN SEE INTERMEDIATE AND FAR DISTANCE. DOCTOR GIVES HIM EYE DROPS (LOTEMAX 4X/DAY, XIIDRA 2X/DAY, SYSTANE 6-8X/DAY) TO ADDRESS HIS VISUAL ISSUES. NO OTHER INFORMATION WAS PROVIDED. THIS MEDICAL DEVICE REPORT (MDR) PERTAINS TO THE RIGHT EYE (OD). A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE (OS).

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 8347025 ↗
• InjuryNov 28, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THERE WAS A REFRACTIVE MISS AFTER THE IMPLANTATION OF THE SYMFONY TORIC INTRAOCULAR LENS (IOL) IN THE PATIENT'S LEFT EYE. REPORTEDLY, THE LENS HAD ROTATED POST-OP AND IT WAS 20 DEGREES OFF AXIS FROM THE INTENDED ORIENTATION. THE PATIENT COMPLAINED OF BLURRY VISION OU (BOTH EYES). THE LENS IS PLANNED TO BE EXCHANGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8109844 ↗
• InjuryJul 26, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS (MODEL ZXT225 AND +22.5 DIOPTER) WAS EXPLANTED FROM THE RIGHT EYE (OD) BECAUSE OF THE PATIENT EXPERIENCING RESIDUAL MYOPIA AND ASTIGMATISM. LENS MODEL ZXT225 +22.0 DIOPTER WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO PATIENT INJURY AND NO OTHER MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS REPORTED DOING GOOD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7721888 ↗
• InjuryApr 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00, +22.5 DIOPTER) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE IN A SECONDARY PROCEDURE BECAUSE OF VISUAL DISTURBANCE AND THE PATIENT HAVING DIFFICULTY FOCUSING AT A DISTANCE. LENS MODEL ZXT225 +21.0 DIOPTER WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. REPORTEDLY THE INCISION WAS ENLARGED DURING THE EXPLANT PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7402141 ↗
• InjuryFeb 8, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A ZXT225 22.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO A LENS MALFUNCTION. THE LENS WAS REPLACED WITH A ZCB00 22.5 DIOPTER IOL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7255164 ↗
• InjuryNov 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 22.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED BECAUSE OF RESIDUAL MYOPIA. REPORTEDLY, THE DOCTOR USES OCULAR RESPONSE ANALYZER (ORA) AND SOMETIMES THE PATIENT DOES NOT LIKE WHAT THE ORA PREDICTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7049473 ↗
• InjuryAug 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT'S HUSBAND INITIALLY REPORTED THAT HIS WIFE RECEIVED A SYMFONY LENS IMPLANT IN EACH EYE AND HAS EXPERIENCED HALOS AND GLARE AND HAS COMPLETELY LOST HER VISION OVER TIME. THROUGH FOLLOW UP ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT¿S FIRST EYE WAS IMPLANTED AROUND (B)(6) AND THE SECOND EYE WAS DONE AROUND (B)(6) TIMEFRAME. FOR THE FIRST 2 WEEKS, HER VISION WAS PERFECT NEAR AND FAR, HOWEVER, AFTER 2 WEEKS HER VISION DRASTICALLY DETERIORATED AND BECAME VERY BLURRY. SHE COULD NOT DRIVE AT NIGHT OR READ AND SHE DOES NOT WANT TO WEAR GLASSES. SHE WILL DRIVE DURING THE DAY ONLY TO FAMILIAR PLACES. HER LEFT EYE IS BETTER THAN HER RIGHT. THE PATIENT SAW HER TWO AND HALF WEEKS AGO, AND THE DOCTOR SAID HER VISION IMPROVED SOMEWHAT AND THAT HER EYE IS HEALING. THE DOCTOR GAVE HER GLASSES TO HELP HER WITH HER NEAR VISION, HOWEVER, IT HURTS HER EYES AND STRAINS THEM AND ARE UNCOMFORTABLE. THE PATIENT SOUGHT A SECOND AND THIRD OPINION TO SEE WHAT HER OPTIONS ARE AND WAS GIVEN CONFLICTING INFORMATION. ONE DOCTOR SAID SHE COULD SWITCH TO A MONOFOCAL LENS AND ANOTHER DOCTOR STATED NOT TO TAKE THE LENS OUT AND TO GIVE IT MORE TIME TO HEAL. FOR NOW, SHE WILL WAIT FOR HER EYE TO HEAL EVE

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 6769929 ↗
• InjuryJun 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A REFRACTIVE SURPRISE AFTER IMPLANTATION OF SYMFONY LENSES IN BOTH EYES. CURRENTLY, THERE IS NO PLAN TO EXPLANT THE LENS FROM THE PATIENT'S LEFT EYE. PATIENT UNDERWENT EXPLANT OF THE LENS IN THEIR RIGHT EYE. ALTHOUGH INITIALLY THERE WAS A PLAN TO EXPLANT THE LEFT EYE (OS), THE PATIENT CANCELED. HENCE, OS HAS NOT BEEN EXPLANTED YET. IT WAS REPORTED THAT IT IS BELIEVED THAT THE PATIENT'S SYMPTOMS MAY HAVE GOTTEN BETTER NOW FOLLOWING EXPLANT AND REPLACEMENT OF THE LENS FROM THE RIGHT EYE. NO FURTHER INFORMATION WAS PROVIDED. EXPLANT OF THE LENS IN THE RIGHT EYE HAS BEEN CAPTURED AND IS PROVIDED IN A SEPARATE MDR FILING.

  Patient problems: No Code Available

  MAUDE report 6648432 ↗
• InjuryMay 16, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXT225 22.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED/EXCHANGED WITH A NON-AMO DEVICE AS THE PHYSICIAN WANTED TO CHANGE THE DIOPTER SIZE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6571495 ↗
• InjuryDec 28, 2016Adverse Event Without Identified Device or Use Problem; Unintended Movement; Adverse Event Without Identified Device or Use Problem; Unintended Movement

  IT WAS REPORTED THAT A ZXT225 22.5 DIOPTER INTRAOCULAR LENS IS SCHEDULED TO BE EXPLANTED AND EXCHANGED FROM THE LEFT EYE OF A FEMALE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6211797 ↗