TECNIS IOL ZXT150 (REF ZXT150U165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05050474605138), received between Dec 29, 2016 and Apr 8, 2020 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 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 PATIENT INTOLERANCE DESCRIBED AS HALOS/GLARE AND OTHER VISUAL DISTURBANCE. IMPLANT SURGERY AND PLACEMENT WAS PERFECT, BUT VISION DESCRIBED AS HORRIBLE. VISUAL CONFUSION, GLARE, HALO, AT ONE WEEK NO IMPROVEMENT. THE IOL WAS REPLACED WITH A MODEL ZCB00 16.5 LENS. NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 9936587 ↗
• InjuryMar 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SYMFONY INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE DUE TO THE PATIENT EXPERIENCING HALO AND GLARE. THE REPLACEMENT LENS IS A THREE PIECE NON-JOHNSON & JOHNSON IOL. THE PATIENT IS REPORTED TO BE DOING WELL POST-EXCHANGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 9815710 ↗
• InjuryApr 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED A ZXT150, 16.5 DIOPTER INTRAOCULAR LENS (IOL) ON (B)(6) 2017. FOLLOW-UP CONFIRMED THAT VISUAL ISSUES STARTED RIGHT AFTER SURGERY. INITIALLY, THE SYMPTOM WAS DESCRIBED AS SHE FEELS LIKE SHE HAS A FILM IN HER RIGHT EYE, BUT FOLLOW-UP CLARIFIED AS SYMPTOM TO BE "FOG/BLURRED" COVERING HER EYE. HER NIGHT DRIVING IS HORRIBLE WITH BLURRY SENSATION LIKE SHE ALWAYS HAS TO CLEAN HER LENSES AS SHE CANNOT SEE CLEARLY. BUT HER DOCTOR SAID THAT HER VISION IS 20/20 NEVERTHELESS, HER VISUAL CONCERNS ANNOY HER. SHE CLAIMS THAT THE VISUAL ISSUES SIGNIFICANTLY INTERFERE WITH HER REGULAR ACTIVITIES. SHE SAID THAT SHE DOES VOLUNTEER WORK BUT HAVE NOT DONE IT ANYMORE BECAUSE OF HER VISUAL CONCERNS. SHE KEPT ON GOING TO HER DOCTOR TO LET THEM KNOW OF HER ISSUES. SHE HAD LASIK IN BOTH EYES TO TRY TO FIX RIGHT EYE AS SHE CLAIMED THAT THE DOCTOR TOLD HER HE MIGHT AS WELL DO BOTH EYES. BUT IT SEEMS THAT THE DOCTOR HAS ALREADY GIVEN UP ON HER. WHEN ASKED ABOUT THE BIONIC FILM GRAFT THAT SHE MENTIONED IN THE INITIAL REPORT, SHE STATED THAT IT WAS DONE ON (B)(6) 2019, AND WAS ABOUT A PIECE SKIN GRAFT THAT WAS PUT IN HER EYE WHICH THE DOCTOR SAID MAY HELP WITH HER VIS

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

  MAUDE report 8562407 ↗
• InjuryOct 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 16.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018, DUE TO AN UNSPECIFIED MECHANICAL COMPLICATION. THE PATIENT COULD NOT ADAPT. THERE WAS AN INCISION ENLARGEMENT AND SUTURE USED. THE REPLACEMENT LENS WAS NON JOHNSON AND JOHNSON LENS. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7982039 ↗
• InjurySep 7, 2018Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A ZXT150 16.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. REPORTEDLY, THE PATIENT IS NOT HAPPY WITH THE CURRENT IMPLANT AND IS LOOKING TO HAVE AN IOL EXCHANGE WITH A DIFFERENT DOCTOR. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7857995 ↗
• InjuryMay 8, 2018Inadequacy of Device Shape and/or Size; Unintended Movement; Inadequacy of Device Shape and/or Size; Unintended Movement

  IT WAS REPORTED THAT A ZXT150 16.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO THE LENS DISLOCATING. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 15.0. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7497462 ↗
• InjurySep 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (MODEL ZXT150, +16.5 DIOPTER) WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE, BECAUSE THE PATIENT WAS NOT HAPPY WITH THE OUTCOME. REPORTEDLY, A DIFFERENT LENS WITH THE SAME DIOPTER SIZE WAS IMPLANTED AS A REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6847545 ↗
• InjuryAug 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A TECNIS SYMFONY TORIC INTRAOCULAR LENS (IOL), MODEL ZXT150 16.5 DIOPTER, WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2016. THE PATIENT HAS NOT BEEN SATISFIED WITH HIS VISUAL OUTCOME. THE PHYSICIAN REPORTS THE PATIENT TOLD HIM THAT HIS VISION, WITHOUT GLASSES, IS BETTER THAN IT WAS PRIOR TO HIS CATARACT SURGERY, HOWEVER HE HAS BEEN UNABLE TO READ WITHOUT GLASSES SINCE SURGERY. THE PHYSICIAN PRESCRIBED BIFOCAL GLASSES. PREOPERATIVELY, THE PATIENT¿S REFRACTION WAS OS: -3.00 +1.75 X 2, VISION WAS 20/30 OU (BOTH EYES), BUT HIS GLARE VISION WAS OS 20/70. THE PATIENT WAS EXAMINED BY A SECONDARY PHYSICIAN WHO RECOMMENDED MORE AGGRESSIVE TREATMENT OF HIS OCULAR SURFACE ISSUES, BUT, DESPITE INTERVENTION, THE PATIENT DID NOT EXPERIENCE ANY IMPROVEMENT IN HIS VISION. THE PATIENT'S RECENT EXAMINATION ON (B)(6) 2017 REVEALED HIS UNCORRECTED VISUAL ACUITY WAS 20/40 AT DISTANCE AND 20/100 AT NEAR, WITH A REFRACTION OF +0.25 +0.75 X 150 +1.75 ADD, HIS VISION WAS 20/25 AT DISTANCE AND 20/20 AT NEAR. FURTHER INFORMATION WAS PROVIDED BY THE PHYSICIAN. HE STATED THAT TO HIM THE PATIENT HAS ACCEPTABLE DISTANCE VISION AND THE COMPLAINT IS WITH INFERIOR NEAR/INTERMEDIATE VISI

  Patient problems: No Code Available

  MAUDE report 6817898 ↗
• InjuryAug 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WILL HAVE A TECNIS SYMFONY TORIC INTRAOCULAR LENS (IOL), MODEL ZXT150 16.5 DIOPTER, EXPLANTED FROM THEIR RIGHT EYE ON (B)(6) 2017. PATIENT COMPLAINED OF NOT BEING HAPPY WITH THEIR NEAR VISION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6805829 ↗
• InjuryFeb 21, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A PATIENT CONTACTED ABBOTT MEDICAL OPTICS TO REPORT HIS EXPERIENCE FOLLOWING IMPLANT OF A SYMFONY INTRAOCULAR LENS, (IOL) MODEL ZCT150. PATIENT REPORTS HIS RESULTS ARE NOT NEARLY WHAT WAS EXPECTED. HE REPORTS HIS VISION NEVER IMPROVED, IT DETERIORATED EVEN AFTER THE SYMFONY LENS WAS IMPLANTED. HE SAID THAT HE HAS STARBURSTS AT NIGHT, CLOSE AND DISTANCE VISION ARE BAD, CANNOT READ, AND IT'S IMPOSSIBLE TO DRIVE ESPECIALLY AT NIGHT. PATIENT IS THINKING THAT MAYBE HE WAS IMPLANTED WITH AN INCORRECT LENS. PATIENT SUGGESTED WE CONTACT HIS DOCTOR FOR FURTHER INFORMATION. FOLLOW UP WAS PROVIDED BY THE DOCTOR WHO CONFIRMED THE PATIENT'S SYMPTOMS. THE DOCTOR ALSO CONFIRMED THAT THE LENS IS WELL CENTERED, BUT ON WAVESCAN THERE WAS SIGNIFICANT ABERRATION ON THE LENS. THERE IS A PLAN TO EXCHANGE THE IOL BUT NO DEFINITE DATE HAS BEEN SET. THE PATIENT WAS 20/30 PRE-OP AND HAS NOW A BEST CORRECTED VISUAL ACUITY (BCVA) OF 20/50 AFTER 3 WEEKS. SURGEON PERFORMED I-TRACE AND NOTED A LOT OF ABERRATIONS ON THE LENS. ON (B)(6) 2017, FURTHER INFORMATION PROVIDED AND IT WAS REPORTED THAT THE INTRAOCULAR LENS WAS EXPLANTED TODAY. THERE WAS NO PATIENT INJURY AND THE PATIENT WAS REPORTED AS 20/20 POST OP. NO

  Patient problems: No Code Available; Visual Disturbances; Visual Impairment

  MAUDE report 6347768 ↗
• 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 COMPLAINTS OF GLARE. THIS REPORT WILL CAPTURE THE ZXT150 THAT WAS EXPLANTED FROM THE PATIENT'S LEFT EYE AND A SEPARATE

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

  MAUDE report 6214732 ↗