TECNIS IOL ZXT225 (REF ZXT225U185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05050474605763), received between May 15, 2017 and Dec 1, 2020 — classified as 12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 RIGHT EYE (OD) 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 OD 20/25. DISTANCE OD 20/25. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 10926196 ↗
• InjuryJul 15, 2020Adverse 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 THE PATIENT'S RIGHT EYE DUE TO THE PATIENT COMPLAINING OF UNWANTED VISUAL IMAGES AND THE LENS WAS NOT WHAT THE PATIENT WAS EXPECTING. THE PATIENT WAS UNHAPPY WITH DISTANCE AND NEAR VISION. THE REPLACEMENT LENS WAS A DIFFERENT MODEL AND HIGHER DIOPTER. THERE WAS NO PATIENT INJURY AND NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT IS STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 10274396 ↗
• InjuryJun 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 18.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2019 BECAUSE THE INCORRECT IOL POWER WAS SELECTED. THE REPLACEMENT LENS WAS ANOTHER MODEL ZXT225 BUT A HIGHER DIOPTER (19.5). THERE WERE NO COMPLICATIONS WITH THE EXCHANGE. THE EXPLANTED LENS IS NOT BEING RETURNED AS IT WAS CUT OUT AND LOST BY THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8702807 ↗
• InjuryApr 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS (MODEL ZXT225, +18.5 DIOPTER) WAS IMPLANTED IN PATIENT¿S RIGHT EYE AND THEN LATER THE LENS WAS REPORTEDLY EXPLANTED IN SECONDARY SURGICAL PROCEDURE BY ANOTHER SURGEON. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8538593 ↗
• InjuryMar 16, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A CLINICAL STUDY PATIENT HAS ZXT225, 18.5 DIOPTER INTRAOCULAR LENS (IOL) BUT HAD IOL ROTATION, FEW WEEKS AFTER IMPLANTATION, FROM 159 DEGREES TO 8 DEGREES, NOTICED DURING INITIAL VISIT. THERE WAS NO PATIENT COMPLICATION AND/OR RELATED INJURY, EXCEPT FOR DOUBLE VISION, HALOS AND GLARE, BUT NONE OF THE SYMPTOMS INTERFERED WITH REGULAR ACTIVITIES. REPOSITION WAS SCHEDULED AND IT WENT WELL AND THERE WERE NO SYMPTOMS REPORTED AT THE 1 DAY VISIT. PATIENT DOING WELL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8427189 ↗
• InjuryJan 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED SYMPTOMS OF DYSPHOTOPSIA POST IMPLANT OF A ZXT225 18.5 DIOPTER INTRAOCULAR LENS (IOL). AN EXPLANT WAS REPORTED TO BE SCHEDULED ON (B)(6) 2018, BUT TO DATE NOT YET CONFIRMED. ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8211057 ↗
• InjurySep 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 18.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO A LACK OF QUALITY IN VISION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 7918929 ↗
• InjurySep 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 18.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED FOR REASONS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7869346 ↗
• InjuryAug 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT REPORTED SHE HAD CATARACT SURGERY IN BOTH EYES (OU) IN (B)(6) 2017, DUE TO NIGHTTIME GLARE AND ASTIGMATISM. SHE HAS BEEN EXPERIENCING NIGHTTIME GLARE AND STARBURSTS SINCE THE LENSES WERE IMPLANTED. A YAG (YTTRIUM ALUMINUM GARNET) LASER PROCEDURE WAS PERFORMED ON THE LEFT EYE (OS), WHICH SHE STATED DID NOT PROVIDE ANY IMPROVEMENT. THE SYMPTOMS WERE AFFECTING HER DAILY ACTIVITIES. REPORTEDLY, THERE IS A PLAN TO HAVE THE LENSES EXPLANTED. THIS FILE REPRESENTS THE RIGHT EYE WHICH HAS BEEN SCHEDULED FOR AN EXCHANGE (B)(6) 2018. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 7786845 ↗
• InjuryFeb 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 18.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. THE PATIENT NOTED BEING TOLD THAT SHE WOULD NOT HAVE TO WEAR GLASSES FOR DISTANCE OR NEAR IF THESE INTRAOCULAR LENSES WERE IMPLANTED. HOWEVER, AT A POST-OP CHECK THE PATIENT WAS TOLD THAT GLASSES WOULD BE NEEDED FOR BOTH CLOSE AND FAR, ESPECIALLY AT NIGHT DUE TO STARBURSTS AROUND ALL LIGHTS THAT MAKES DRIVING DIFFICULT. THE PATIENT IS AGAIN WEARING BI-FOCALS. THE PATIENT ALSO COMPLAINED OF BLURRY VISION, UP CLOSE AND FAR AWAY, INCLUDING HALOS WHICH ARE WORSE WHEN IT'S RAINING. AN EXAMPLE GIVEN WAS THE COMPUTER SCREEN WASN'T CLEAR AND SIGNS APPEARED BLURRY. THE PATIENT WAS PRESCRIBED BIFOCAL GLASSES, BUT HAS NOT FILLED THE PRESCRIPTION YET, WHICH WERE SPHERE -0.75 ADD 2.25. REPORTEDLY, THE PATIENT HAD A FOLLOW UP VISIT WITH THE DOCTOR ON (B)(6) 2018. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENSES IMPLANTED. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE PATIENT'S RIGHT EYE. A SEPARATE REPORT WILL BE FILED FOR THE LEFT EYE.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 7265831 ↗
• InjuryNov 27, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXT225 18.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE (OS) ON (B)(6) 2017. POST-OPERATIVELY, THE PATIENT'S REFRACTION WAS +0.50 X +0.75. IT WAS LATER EXPLANTED ON (B)(6) 2017 DUE TO A REFRACTIVE SURPRISE. REPORTEDLY, THE LENS WAS CUT IN HALF AND REMOVED. THERE WAS NO EXTENSION OF THE INCISION SINCE THE LENS WAS CUT IN HALF TO REMOVE, BUT A SUTURE WAS USED. POST-OPERATIVELY, ON (B)(6) 2017, THE DOCTOR REPORTED THE PATIENT AS HAVING SOME EDEMA, SO THE VISION IS NOT OPTIMAL. THE LENS WAS REPLACED WITH THE SAME MODEL, BUT DIFFERENT DIOPTER OF 19.5. REPORTEDLY, THE PATIENT HAD A FOLLOW UP SCHEDULED TO SEE THE DOCTOR ON (B)(6) 2017. THE PATIENT IS HAPPY AND SEEING BETTER WITH A VISUAL ACUITY OF 20/50 AND J5, WHICH THE DOCTOR REPORTED AS BEING BECAUSE OF RESIDUAL ASTIGMATISM FROM THE SUTURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Corneal Edema; No Code Available

  MAUDE report 7060702 ↗
• InjuryMay 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 18.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE FROM A MALE PATIENT'S RIGHT EYE DUE TO AN UNEXPECTED VISUAL OUTCOME. THERE WAS SIGNIFICANT ADDITIONAL ASTIGMATISM AND AXIS CHANGE LEAVING THE PATIENT HYPEROPIC. THE PATIENT ALSO EXPERIENCED BLURRED VISION AT DISTANCE AND NEAR. THE LENS WAS REPLACED WITH A HIGHER DIOPTER ZXR00 IOL (20.5). IT WAS INDICATED THAT THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 6568015 ↗