TECNIS IOL ZXT150 (REF ZXT150U160)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 05050474605121), received between Dec 8, 2016 and Dec 9, 2024 — classified as 16 injuries.

The most frequently reported specific device problem is “Unintended Movement” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DOCTOR HAD TO EXCHANGE A SYMPHONY INTRAOCULAR LENS (IOL). REASON FOR EXPLANT WAS DUE TO VISUAL ISSUES OF GLARE AND DOUBLE VISION IN THE RIGHT EYE. THERE WAS VITRECTOMY AND ENLARGEMENT OF PRIMARY INCISION. THE ORIGINAL LENS WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL. PATIENT OUTCOME INDICATED AS LOVELY, SO FAR SO GOOD. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Disturbances; Visual Impairment

  MAUDE report 20887060 ↗
• InjuryMar 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ZXT150 INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE DUE TO COMPLAINTS OF BLURRY DISTANCE VISION, HAZY, GLARE AND REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION LENS WITH 19.5 DIOPTER. THERE WAS NO SERIOUS PATIENT INJURY AND NO VITRECTOMY HOWEVER THERE WAS PLANNED INCISION ENLARGEMENT AND PLANNED SUTURE(S). PATIENT OUTCOME POST-LENS EXCHANGE WAS REPORTED AS IMPROVED BUT PATIENT IS SEEING RETINA SPECIALIST FOR AN UNRELATED ISSUE. IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 16569974 ↗
• InjuryJun 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINS OF NEAR VISION IS NOT AS GOOD AS SHE WANTS, HOWEVER, SHE DOES NOT WANT TO TAKE OUT THE INTRAOCULAR LENS (IOL) . THE PATIENT CAN READ HER CREDIT CARD, BUT NEEDS TO PUT ON READERS TO READ THE EXPIRATION DATE ON CREDIT CARD. THE SURGEON STATED THE LENS MEETS EXPECTATIONS. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE CONDITION IS DEBILITATING AS THE PATIENT CANNOT SEE INTERMEDIATE DISTANCE. THE PATIENT RECEIVED PATIENT EDUCATION AS PATIENT TREATMENT. THE LENS REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 12029236 ↗
• InjuryJun 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AT 1 MONTH STUDY VISIT, THE SUBJECT HAD DIFFICULTY AND WAS MODERATELY BOTHERED BY HALOS AND STARBURSTS LIMITING NIGHT DRIVING AN INTRAOCULAR LENS (IOL) IN THE RIGHT EYE. IN THE NON-DIRECTED OCULAR VISUAL SYMPTOMS THE SUBJECT COMPLAINED OF BLURRED VISION/DIFFICULTY WITH VISION NEAR, HALOS, NIGHT GLARE, AND STARBURSTS. THE MONOCULAR UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) - OD 20/15; OS 20/15. MONOCULAR BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) ¿ OD 20/15; OS 20/15. THE LENS REMAINS IMPLANTED. THERE WAS NO TREATMENT PROVIDED OR PLANNED. THE SUBJECT RETURNED FOR THE 6 MONTH STUDY VISIT. THE SUBJECT REPORTED BEING VERY BOTHERED BY POOR LIGHT VISION. IN THE NON-DIRECTED OCULAR VISUAL SYMPTOMS THE SUBJECT REPORTED DIFFICULTY WITH VISION IN LOW LIGHT AND DECREASED NEAR VISION WITH AN INTRAOCULAR LENS (IOL). THE MONOCULAR UCDVA: OD 20/15; OS 20/20. MONOCULAR BCDVA: OD 20/15; OS 20/15. THE PI (PRINCIPLE INVESTIGATOR) ASSESSED THE COMPLAINT TO BE RELATED TO THE PROPERTIES OF THE IOL AND THE SYMPTOMS WERE NOTED AS DEBILITATING BY THE SUBJECT. THERE ARE NO PLANS FOR ADDITIONAL TREATMENT OR INTERVENTION AT THIS TIME. NO ADDITIONAL INFORMATION PROVIDED. PATIENT HAS BILATER

  Patient problems: Blurred Vision; Halo; Visual Impairment

  MAUDE report 10136506 ↗
• InjuryAug 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT A MODEL ZXT150 16.0 DIOPTER INTRAOCULAR LENS (IOL)WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE DUE TO THE PATIENT¿S DISSATISFACTION WITH THE LENS, AND REQUEST TO HAVE A MONOFOCAL IOL. THE ZXT150 LENS WAS EXPLANTED AND REPLACED WITH A MODEL PCB00 15.5 DIOPTER IOL. THE EXPLANTED LENS IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8919467 ↗
• InjuryAug 14, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZXT150 16.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2019. AT 1 DAY POSTOP, THE LENS ROTATED > 10 DEGREE RESULTED IN UNEXPECTED REFRACTION. CONSEQUENTLY, PATIENT COMPLAINED OF HALOS AND GLARE. THE LENS WAS EXPLANTED ON (B)(6) 2019 AND REPLACED WITH THE SAME MODEL AT A LOWER DIOPTER, 15.0. PATIENT HAS RECOVERED POST-OPERATIVELY. THE CUSTOMER ALSO INDICATED THAT THE LENS IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8892136 ↗
• InjuryJul 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT THE 1-MONTH CLINICAL STUDY VISIT THE PATIENT WAS BOTHERED BY HALOS AND STARBURSTS CAUSING DIFFICULTY WHILE DRIVING. BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) 20/15. ADDITIONAL INFORMATION RECEIVED FROM THE 6-MONTH CLINICAL STUDY VISIT REPORTED THAT PATIENT NOTED BEING BOTHERED BY HALOS AND STARBURSTS. THE SYMPTOMS DO INTERFERE WITH DAILY ACTIVITIES (DRIVING). UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) 20/15. THE IOL REMAINS IMPLANTED IN THE SUBJECT EYE WITH NO INTERVENTION PLANNED. THIS MDR IS FOR THE RIGHT EYE. A SEPARATE MDR IS BEING SUBMITTED FOR THE LEFT EYE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 8800742 ↗
• InjuryMar 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 16.0 INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2018 AND SUBSEQUENTLY EXPLANTED FROM THE PATIENT RIGHT EYE ON (B)(6) 2019 DUE TO GLARE AND DECREASED VISION. A REPLACEMENT LENS OF THE SAME MODEL BUT DIFFERENT DIOPTER (17.0) WAS IMPLANTED AND THE PATIENT IS HAPPY; THE SYMPTOMS HAVE RESOLVED. THERE WAS NO PATIENT INJURY AND NO OTHER MEDICAL OR SURGICAL INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 8427473 ↗
• InjuryJan 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 16.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2019 BECAUSE THE PATIENT EXPERIENCED INTOLERABLE HALO AND GLARE. THE INCISION WAS ENLARGED TO 3MM AND A SUTURE WAS USED. THE REPLACEMENT LENS WAS A NON-JOHNSON AND JOHNSON LENS. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENSES IMPLANTED. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE PATIENT'S LEFT EYE. A SEPARATE REPORT WILL BE FILED FOR THE RIGHT EYE.

  Patient problems: Halo; No Code Available

  MAUDE report 8234672 ↗
• InjuryOct 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS SYMFONY TORIC (MODEL ZXT150 +16.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE BECAUSE SHE WAS NOT HAPPY WITH HER VISION. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7954015 ↗
• InjuryOct 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS SYMFONY TORIC (MODEL ZXT150 +16.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S LEFT EYE BECAUSE SHE WAS NOT HAPPY WITH HER VISION. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7953814 ↗
• 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 ZXT150, +16.0 DIOPTER) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE BECAUSE OF THE PATIENT COMPLAINING OF HALOS AND GLARE. LENS MODEL AAB00, +15 DIOPTER WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. NO INCISION ENLARGEMENT, NO VITRECTOMY OR ANY OTHER MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS REPORTED TO BE STABLE WHEN DISCHARGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 7402106 ↗
• InjuryFeb 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) MODEL NUMBER (B)(4) 16.0 DIOPTER WAS EXPLANTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7268883 ↗
• InjuryJan 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 16.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE LEFT EYE (OS) OF THE PATIENT ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 DUE TO BLURRY VISION. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES. THE LENS WAS REPLACED WITH A NON-AMO LENS 18.5 DIOPTER. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7204609 ↗
• InjuryDec 29, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT A PHYSICIAN WHO WAS NEW TO OFFERING PRESBYOPIA CORRECTING INTRAOCULAR LENSES HAD A PATIENT THAT WAS NOT DOING WELL AFTER A BILATERAL SYMFONY LENS IMPLANTS. THE FIRST EYE WAS OPERATED ON (B)(6) 2016 AND AT 1 DAY POST-OP, THE PATIENT¿S VISUAL ACUITY (VA) WAS 20/50 J7 WITH A LOT OF DRYNESS IN THE CORNEA. THE PHYSICIAN BELIEVES THIS TO BE DUE TO THE KETOROLAC DROPS AND STOPPED USING IT AT 1 WEEK POST OP. AT 3 WEEKS POST-OP, PATIENT WAS 20/50 J3 AND CORNEA IS MUCH BETTER THAN BEFORE, WITH A REFRACTION -0.5D BUT THIS WAS NOT PUSHING PLUS. ADDITIONALLY, THE OTHER EYE HAD SURGERY ON (B)(6) 2016 AND VA IS CURRENTLY 20/40 J3. PATIENT ALSO COMPLAINS OF SOME GLARE. AT A LATER FOLLOW UP IT WAS LEARNED THAT BOTH LENSES WERE MODEL ZXT150 AND BOTH WERE EXPLANTED ON (B)(6) 2016. THE RIGHT EYE (OD) WAS REPLACED WITH MONOFOCAL TORIC IOL. A CAPSULAR TEAR WAS REPORTED FOR THE LEFT EYE (OS) AND A MODEL ZA9003 LENS WAS USED. THE PATIENT¿S VISION WAS REPORTED TO BE OD 20/40 DISTANCE, J3 NEAR AND THE OS 20/50 DISTANCE, J3 NEAR. GOOD VISION AT 10 FEET HOWEVER COMPLAINS OF GLARE. THIS REPORT WILL CAPTURE THE ZXT150 THAT WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE AND A SEPARATE

  Patient problems: Dry Eye(s); No Code Available

  MAUDE report 6214765 ↗
• InjuryDec 8, 2016Adverse 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 LEFT EYE DUE TO PATIENT DISSATISFACTION WITH HER NEAR VISION. INCISION WAS SLIGHTLY ENLARGED IN ORDER TO EXPLANT THE LENS SAFELY. THERE WAS NO PATIENT POST-OP INJURY. LENS WAS REPLACED WITH A ZCT150 15.5 DIOPTER IOL. THE LENSES WERE EXPLANTED FROM PATIENT'S RIGHT AND LEFT EYE. THIS REPORT WILL CAPTURE THE LENS EXPLANTED FROM THE LEFT EYE AND SEPARATE MDR WILL BE FILED FOR THE LENS EXPLANTED FROM THE RIGHT EYE.

  Patient problems: No Code Available

  MAUDE report 6153740 ↗