TECNIS IOL ZXT225 (REF ZXT225U215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 05050474605824), received between Feb 28, 2017 and Nov 6, 2023 — classified as 17 injuries, 1 malfunction.

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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON HAD EXPLANTED TECNIS SYMPHONY TORIC INTRAOCULAR LENS (IOL) OF 21 DIOPTER. REPORTEDLY, THREE PIECE SPHERICAL MONOFOCAL IOL WITH MODEL ZA9003 AND 21.0 DIOPTER WAS USED AS A REPLACEMENT LENS FOR THE PATIENT. LENS IS NOT BEING RETURNED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 18078003 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FIRST HAD A SURGERY IN THE LEFT EYE WITH A TORIC LENS AND FOLLOWED BY A SURGERY IN THE RIGHT EYE WITH A MULTIFOCAL LENS. PATIENT STATED THAT BOTH THE DISTANCE VISION AND NEAR VISION WAS SHARPER WITH THE RIGHT EYE AND WANTED THE SAME TYPE OF LENS IN THE LEFT EYE TOO. THE PRE-OPERATIVE VISUAL ACUITY WAS 20/40 AND THE POST-OPERATIVE VISUAL ACUITY WAS 20/30-2. HENCE, THE ORIGINAL TORIC LENS WAS EXPLANTED AND ANOTHER MULTIFOCAL LENS (MODEL ZLU, 22.5 DIOPTER) WAS PLACED AS THE REPLACEMENT IN THE LEFT EYE. THE INCISION WAS AN ENLARGED; HOWEVER, NO OTHER INTERVENTIONS WERE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 12375658 ↗
• InjuryApr 7, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A ZXT225 MODEL INTRAOCULAR LENS(IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE IN A SECONDARY SURGICAL PROCEDURE DUE TO GLARES, HALOS AND ALSO MECHANICAL COMPLICATIONS OF LENS FOR WIDE RANGE OF FOCUS. SYMPTOMS HAD ONSET MONTHS AFTER SURGERY. OUTCOME HAD SIGNIFICANTLY INTERFERED WITH DAILY ACTIVITIES OF LIFE. THIS EVENT WAS OBSERVED DURING POST-OP EXAMINATION. THE REPLACEMENT LENS USED IS A DIFFERENT MODEL BUT SAME DIOPTER LENS. PATIENT HAD RECOVERED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 11627162 ↗
• InjuryMar 19, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THERE WAS A POWER MISS POST-IMPLANT OF AN INTRAOCULAR LENS (IOL). THERE WAS UNEXPECTED -2.75 DIOPTER POST-OPERATIVE RESULT. THE PATIENT HAD BLURRED VISION AND THE 21.5 DIOPTER LENS WAS EXPLANTED FROM PATIENT'S LEFT EYE AND REPLACED WITH ANOTHER MODEL ZXT LENS 19.0 DIOPTER. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 11532672 ↗
• InjuryJan 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SYMFONY TORIC INTRAOCULAR LENS (IOL), MODEL ZXT225 21.5 DIOPTER WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE (OD) DUE TO UNEXPECTED POST-OP REFRACTION AND UNCORRECTED VISUAL ACUITY (UCVA), BLURRY VISON. IT WAS NOTED THE PATIENT'S SYMPTOMS SIGNIFICANTLY INTERFERED WITH THEIR ACTIVITIES OF DAILY LIFE. THE EXPLANTED LENS WAS REPLACED WITH A MODEL ZXT300 20.5 DIOPTER IOL. THE PRODUCT IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED BY THE CUSTOMER. ON (B)(6) 2019 THE PATIENT'S REFRACTION WAS: - 1.25, +0.75, X052. UCVA WAS 20/40-1. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9630203 ↗
• InjuryNov 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 INTRAOCULAR LENS (IOL) WAS SCHEDULED TO BE EXPLANTED IN ABOUT TWO WEEKS DUE TO VISUAL DISTURBANCE/FLUCTUATION IN VISION. REPLACEMENT LENS IS PLANNED TO BE A TECNIS MONOFOCAL TORIC LENS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 9365540 ↗
• InjurySep 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZXT225 INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO PATIENT COMPLAINT OF BOTHERSOME BLURRY VISION. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9114428 ↗
• InjuryJul 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT COMPLAINED OF GLARE AND HALOS POST-IMPLANT OF A MODEL ZXT225 INTRAOCULAR LENS (IOL) IN THE RIGHT EYE. THE SUSPECT IOL WAS EXPLANTED AND REPLACED WITH ANOTHER ZCT225 IOL, BUT A LOWER DIOPTER (20.5). NO COMPLICATIONS OCCURRED. THE PATIENT WAS DOING WELL POST-EXCHANGE. THE SUSPECT IOL IS AVAILABLE FOR RETURN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8843566 ↗
• InjuryDec 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO GLARE AND REFRACTIVE ERROR. THE LENS WAS REPLACED WITH A MONOFOCAL LENS, A MODEL ZCT225 +21.0 DIOPTER. THE PATIENT WAS REPORTEDLY DOING WELL POST OP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8207064 ↗
• MalfunctionFeb 21, 2018Scratched Material; Scratched Material

  IT WAS REPORTED THAT A ZXT225 21.5 DIOPTER INTRAOCULAR LENS (IOL) WAS OUT OF ITS PROPER POSITION WITHIN THE JEWEL CASING AND HAD A SCRATCH ON IT WHEN IT WAS CHECKED UNDER THE MICROSCOPE. THIS OCCURRED DURING HANDLING AND PRIOR TO INSERTION WITH NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7287737 ↗
• InjuryJan 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 21.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 BECAUSE OF PATIENT DISSATISFACTION. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED. THE REPLACEMENT LENS WAS A ZLB00 21.5 DIOPTER LENS. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING GOOD POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7182234 ↗
• InjuryJan 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 21.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 BECAUSE OF PATIENT DISSATISFACTION. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED. THE REPLACEMENT LENS WAS A ZLB00 21.5 DIOPTER LENS. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING GOOD POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7182216 ↗
• InjuryNov 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 21.5 DIOPTER INTRAOCULAR LENS (IOL) EXPLANTED FROM THE PATIENT'S OPERATIVE EYE DUE TO RESIDUAL MYOPIA. ALSO, IT WAS REPORTED THAT THE DOCTOR USES OCULAR RESPONSE ANALYZER (ORA) AND SOMETIMES THE PATIENTS DO NOT LIKE WHAT THE ORA PREDICTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7051615 ↗
• InjuryOct 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 21.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 DUE TO A LOSS OF BEST CORRECTED VISION. THE ANTICIPATED BEST CORRECTION VISION WAS 20/20 OR 20/25, BUT RESULTED IN 20/40. THERE WAS NO INCISION ENLARGEMENT, BUT SUTURE USE WAS CONFIRMED. REPORTEDLY, THERE WAS NO PATIENT INJURY. THE LENS WAS REPLACED WITH A ZKB00 21.0 DIOPTER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 6967647 ↗
• InjurySep 13, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXT225 21.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017, BECAUSE A OCULAR RESPONSE ANALYZER (ORA) GAVE WRONG CALCULATIONS LEADING TO THE WRONG SIZE LENS FOR THE PATIENT, WHICH GAVE THE PATIENT TOO MUCH CORRECTION FOR ASTIGMATISM. PRE-OPERATIVELY, THE TARGET REFRACTION WAS -.050 AND THE REFRACTION WAS -0.50 +0.50 X 070. HOWEVER, THE POST-OPERATIVE REFRACTION WAS -225 +275 X 005, BEST CORRECTED VISUAL ACUTITY (BCVA) 20/25, AND CURRENT ORIENTATION OF IOL WAS 38 DEGREES. THERE WAS NO INCISION ENLARGEMENT OR VITRECTOMY PERFORMED. REPORTEDLY, THE PATIENT IS DOING WELL. THE LENS WAS REPLACED WITH A ZCB00 21.0 DIOPTER IOL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6863919 ↗
• InjurySep 8, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A DOCTOR NOTICED GLISTENING ON SYMFONY INTRAOCULAR LENSES (IOL) THAT HE HAD BILATERALLY IMPLANTED INTO A PATIENT 3 MONTHS AGO. IN ADDITION, THE PATIENT COMPLAINED OF BLURRY VISION AND FLASHING OF LIGHTS. A ZXT225 21.5 DIOPTER IOL WAS IMPLANTED INTO ONE OF THE OPERATIVE EYES ON (B)(6) 2017. HOWEVER, IT WAS NOT SPECIFIED WHETHER IT WAS THE LEFT OR RIGHT. REPORTEDLY, THE SURGEON IS CONSIDERING AN EXPLANT IN THE NEXT FEW MONTHS, BUT IT WAS NOT SPECIFIED WHICH EYE WILL BE EXPLANTED FIRST. THE LENS WILL BE REPLACED WITH A NON-AMO CONVENTIONAL MONOFOCAL IOL. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENSES IMPLANTED. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN ONE OF THE PATIENT'S EYE. A SEPARATE REPORT WILL BE FILED FOR THE COMPANION EYE.

  Patient problems: Blurred Vision; No Code Available; Visual Disturbances

  MAUDE report 6854166 ↗
• InjuryApr 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT A MODEL ZXT225 21.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO THE PATIENT EXPERIENCING ISSUES WITH GLARE, HYPEROPIA AND ASTIGMATISM. ON (B)(6) 2017 THE PHYSICIAN EXPLANTED THE ZXT225 LENS AND ATTEMPTED TO REPLACE IT WITH A NON AMO DEVICE TO HELP THE PATIENT FOCUS A LITTLE BETTER. HOWEVER, THIS PROCEDURE WAS UNSUCCESSFUL AS THE LENS DID NOT SIT PROPERLY, THE CAPSULE TORE AND A VITRECTOMY WAS PERFORMED. THIS LENS WAS THEN REPLACED WITH A MODEL ZXT300 21.0 DIOPTER LENS, BUT UNFORTUNATELY IT WENT IN THE EYE UPSIDE DOWN AND WAS SUBSEQUENTLY ALSO REMOVED FROM THE EYE DURING THE SAME PROCEDURE. THE PHYSICIAN INDICATED THE LENS WAS NOT FULLY PLACED IN THE EYE. THERE WAS NO PATIENT INJURY. FINALLY A THIRD LENS MODEL ZXR00 22.0 DIOPTER LENS WAS IMPLANTED TO LEAVE HER BALANCED WITH HER VISION BETWEEN THE TWO EYES. THE PATIENT HAD CORNEAL EDEMA, BUT HAS CLEARED AND HAS A NORMAL FUNCTIONAL RETINA. SHE IS NEARSIGHTED. THE PATIENT MAY DO A PRK (PHOTOREFRACTIVE KERATECTOMY) IN THE FUTURE OR A LASIK PROCEDURE. THIS LENS WAS NOT SAVED FOR RETURN.

  Patient problems: No Code Available

  MAUDE report 6523770 ↗
• InjuryFeb 28, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A PHYSICIAN HAD A PATIENT WITH A STEEP 6 DEGREE PLACEMENT THAT ROTATED 15 DEGREES COUNTER CLOCKWISE TO ~20 DEGREES ON HER LEFT EYE. THE PATIENT WAS 20/100 UNCORRECTED AND CORRECTED TO 20/70 WITH +0.75 -1.50 X 67 AND READING POWER IS 20/70. THE PHYSICIAN IS REQUESTING RE-ROTATION CALCULATION ASSISTANCE TO ADJUST THE LENS. THE PHYSICIAN ALSO PLANS TO CORRECT THE ASTIGMATISM. THE IOL WAS REPOSITIONED (B)(6) 2017. PATIENT STILL HAS 20/100 VISUAL ACUITY AND THE DOCTOR PLANS TO GIVE HER PRESCRIPTION EYE GLASSES. NO PLAN TO EXPLANT THE LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6365197 ↗