TECNIS IOL ZXT150 (REF ZXT150U155)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05050474605114), received between Nov 16, 2017 and Oct 21, 2021 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryOct 21, 2021Unstable; Unstable

  IT WAS REPORTED THAT A ZXT150 MODEL INTRAOCULAR LENS (IOL) HAD ROTATED. ACCOUNT'S BRIEF DESCRIPTION OF THE EVENT INDICATED THAT DURING THE POST-OPERATIVE VISIT PATIENT HAD STATED THAT RIGHT EYE (OD) FELT WEAKER THAN LEFT EYE (OS). VISUAL ACUITY OD HAD DECREASED AS IT WAS 20/30 ON (B)(6) 2021 AND MEASURED AT 20/40 ON (B)(6) 2021, THE DAY OF THE POST-OPERATIVE VISIT. THE LENS IN THE OD WAS REPOSITIONED ROTATIONALLY FROM 78 DEGREES TO 18 DEGREES AND REMAINS IMPLANTED. THERE WAS NO PATIENT INJURY AND NO OTHER MEDICAL/ SURGICAL INTERVENTIONS WERE DONE. PATIENT WAS DOING EXCELLENT WHEN DISCHARGED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Visual Impairment

  MAUDE report 12677854 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT HE HAD A ZXT150 INTRAOCULAR LENS (IOL) IMPLANTED IN HIS RIGHT (OD) EYE ON (B)(6) 2019. HE IS COMPLAINING OF BLURRY VISION, STARBURST, HALO AND GLARE, AND HAS POOR NEAR VISION. HE IS NOW REQUIRED TO WEAR GLASSES FOR READING. THE DOCTOR PRESCRIBED BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION 0.2% FOR HIS EYES FOR NOW UNTIL HIS NEXT CONSULTATION VISIT. THE LENS REMAINS IMPLANTED AND NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HAS BILATERAL IMPLANTS. THIS REPORT REPRESENTS THE RIGHT EYE. A SEPARATE REPORT IS SUBMITTED FOR THE LEFT EYE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 9493818 ↗
• InjuryApr 11, 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 ZXT150 +15.5 DIOPTER) WAS PLANNED TO BE EXPLANTED FROM PATIENT¿S RIGHT EYE BECAUSE OF PATIENT INABILITY TO TOLERATE POST IMPLANT VISION. REPORTEDLY THE PATIENT COMPLAINED OF ROAD SIGNS BEING FUZZY, EVERYTHING HAS A GLOW TO IT, NEED TO HOLD THINGS FAR TO READ, DIFFICULT TO WORK ON THE COMPUTER, HALOS ON COMPUTER AND GLARE ISSUES. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE LENS WAS EXPLANTED IN SECONDARY PROCEDURE USING PHACOEMULSIFICATION. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 8502376 ↗
• InjuryMar 31, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT AFTER THE IMPLANTATION OF LENS MODEL, ZXT150 MULTIFOCAL IOL (INTRAOCULAR LENS) IN THE PATIENT'S LEFT EYE (OS) THERE WAS A MODERATE MECHANICAL MALFUNCTION OF THE LENS AS THE PATIENT EXPERIENCED SIGNIFICANT GHOSTING. REPORTEDLY, THIS OUTCOME SIGNIFICANTLY INTERFERED WITH THE PATIENT¿S DAILY ACTIVITIES. AS A RESULT, THE LENS WAS EXPLANTED, AND THE PATIENT WAS REPORTED AS RECOVERED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8467973 ↗
• InjuryNov 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) MALE PATIENT REPORTED THAT HE HAD BILATERAL INTRAOCULAR LENS IMPLANT IN (B)(6) 2017, AND ISSUES STARTED ALMOST IMMEDIATELY AFTER THE LENSES WERE IMPLANTED. REPORTEDLY, THE ISSUES ARE VARIABLE FOCUS (SOMETIMES HIS VISION IS FINE, OTHER TIMES IT IS BLURRY), NIGHT VISION IS BAD DUE TO HALOS AND HE HAS CONTRAST ISSUES. HE IS ALSO EXPERIENCING SOME TEARING. THE TEARING CAN OCCUR WHEN LOOKING AT ITEMS CLOSE-UP SUCH AS WHEN LOOKING AT HIS DINNER PLATE OR FAR AWAY WHEN READING ROAD SIGNS. THE PATIENT REPORTED THAT ACCORDING TO HIS DOCTOR, THE LENSES ARE WELL POSITIONED AND THERE WERE NO ISSUES DURING THE IMPLANTATION. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT PERTAINS TO THE RIGHT EYE (OD). A SEPARATE MDR WILL BE FILED FOR THE LEFT EYE (OS).

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 8068648 ↗
• InjuryJun 11, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A ZXT150 15.5 DIOPTER LENS WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE LENS SUBLUXED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 17.0. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7589646 ↗
• InjuryJun 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 15.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED BECAUSE THE PATIENT COMPLAINED OF BEING NOT HAPPY WITH THE QUALITY OF THEIR VISION AND SAID IT WAS LIKE LOOKING THROUGH WATER AT THEIR ONE DAY POST-OPERATIVE VISIT ON (B)(6) 2018. THE EXPLANTED LENS WAS REPLACED WITH A MODEL ZCB00 LENS. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING EXCELLENT POST-EXCHANGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 7585565 ↗
• InjuryJun 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXT150, +15.5 DIOPTER) WAS SCHEDULED FOR AN EXPLANT BECAUSE OF PATIENT EXPERIENCING GLARE AT NIGHT WHICH IS BLINDING, SEES RINGS AND AN AERIAL LIKE WHISP OR SMOKE. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS CONFIRMED THAT THE EXPLANT WAS PERFORMED WITH NO PATIENT INJURY AND NO WOUND ENLARGEMENT. REPORTEDLY, A MODEL ZCT150 +15.5 DIOPTER LENS WAS USED AS REPLACEMENT FOR THE PATIENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7563659 ↗
• InjuryFeb 27, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS (MODEL ZXT150, +15.5 DIOPTER) WAS EXPLANTED IN A SECONDARY PROCEDURE BECAUSE OF PATIENT COMPLAINING OF VISUAL DISTURBANCE AND WAS NOT HAPPY WITH THE RESULTS FOLLOWING THE LENS IMPLANT. REPORTEDLY A MODEL ZMA00 +15.0 DIOPTER INTRAOCULAR LENS WAS IMPLANTED AS THE REPLACEMENT LENS FOR THE PATIENT. ADDITIONAL INFORMATION REPORTS THAT THE LENS DISLOCATED POST IMPLANTATION. REPORTEDLY A VITRECTOMY AND LIMBAL RELAXING INCISION WERE PERFORMED DURING THE EXPLANT. PATIENT HAS DRY EYE SYNDROME AND WAS DOING WELL WHEN DISCHARGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances; Vitrectomy

  MAUDE report 7301428 ↗
• MalfunctionFeb 21, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXT150 15.5 DIOPTER) WAS INSERTED INTO THE EYE. AFTER IMPLANTATION, THE DOCTOR NOTICED A STICKY SUBSTANCE ADHERED TO THE POSTERIOR SURFACE OF THE LENS WHICH HE TRIED TO REMOVE. HOWEVER, HE WAS UNABLE TO REMOVE ALL OF IT AS IT WAS EXTREMELY DIFFICULT TO REMOVE. THE REMAINING DEBRIS WAS LEFT IN THE PERIPHERY OF THE LENS. THE DOCTOR DESCRIBED THE MATERIAL AS A GOOEY TYPE SUBSTANCE. THE ACCOUNT WAS BEEN BRIEFED AGAIN ON THE PROPER CARE AND HANDLING OF THE PRODUCTS BEFORE USE. BY THE SALES REP. AS OF RIGHT NOW, THE DOCTOR IS GOING TO LEAVE THE IMPLANT ALONE. THE DOCTOR STATED HE MIGHT ATTEMPT TO YAG THE MATERIAL AT A LATER DATE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7287873 ↗
• InjuryNov 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 15.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE. IT WAS LATER EXPLANTED BECAUSE AN INCORRECT POWER WAS CHOSEN FOR THE BEST CORRECTED OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7039732 ↗