TECNIS IOL ZXR00 (REF ZXR00U0150)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 05050474591745), received between Feb 13, 2017 and Jun 6, 2023 — classified as 21 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED BILATERAL INTRAOCULAR LENSES (IOLS). BOTH IOLS WERE EXPLANTED DUE TO GLARE, HALOS, DIFFICULTY NIGHT DRIVING. PATIENT DID NOT FEEL SAFE, OR BEING ANYWHERE THERE WERE LIGHTS. IT WAS STATED THAT THE VISUAL SYMPTOMS SIGNIFICANTLY INTERFERED WITH DAILY ACTIVITY. FURTHER REPORT STATED UNABLE TO DRIVE AT NIGHT DUE TO STARBURST. PATIENT DENIES ANY PAIN, DISCOMFORT, NEW FLASHES, OR FLOATERS FOR BOTH EYES. BUT PATIENT FEELS VISION WORSENED OVER THE LAST FEW MONTHS. IT WAS NOTED THAT THE CONTACT PERSON STATED THAT PATIENT'S VISUAL ISSUES OCCURRED POST-IMPLANT RIGHT AWAY HOWEVER WAS DIAGNOSED ON (B)(6)2022. NON-JOHNSON AND JOHNSON LENSES WERE USED AS REPLACEMENT (15.5 DIOPTER IN RIGHT EYE, 15.0 DIOPTER IN LEFT EYE). THERE WAS NO VITRECTOMY OR SUTURES DONE. PATIENT WAS GREAT POST-OP, NO HALO OR GLARE SEEING 20/20 UNCORRECTED IN THE DISTANCE AND J5 UNCORRECTED. NO OTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO THE LEFT EYE (OS). A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT EYE (OD).

  Patient problems: Blurred Vision; Flashers; Halo; Visual Disturbances

  MAUDE report 17067946 ↗
• InjuryJan 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 MODEL INTRA OCULAR LENS(IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE DUE TO PATIENT'S VISUAL ISSUES. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT VISUAL SYMPTOMS EXPERIENCED BY THE PATIENT WAS THAT BILATERAL OPTICAL IMAGES ARE TOO MUCH. NO MEDICAL/SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURES WERE REQUIRED. THE REPLACEMENT LENS USED IS A NON-JOHNSON & JOHNSON VISION LENS. THE PATIENT WAS DOING WELL AT THE TIME OF DISCHARGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 11204612 ↗
• InjuryJan 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 MODEL INTRA OCULAR LENS(IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE IN A SECONDARY SURGICAL PROCEDURE DUE TO PATIENT'S VISUAL ISSUES. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT VISUAL SYMPTOMS EXPERIENCED BY THE PATIENT WAS THAT BILATERAL OPTICAL IMAGES ARE TOO MUCH. NO MEDICAL/SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURES WERE REQUIRED. THE REPLACEMENT LENS USED IS A NON-JOHNSON & JOHNSON VISION LENS. THE PATIENT WAS DOING WELL AT THE TIME OF DISCHARGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 11204224 ↗
• InjuryDec 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORT OF EXPLANT OF LENS IMPLANT FROM THE PATIENT¿S RIGHT EYE DUE TO REFRACTIVE ERROR IN CALCULATION. IT WAS REPLACED WITH THE SAME MODEL NUMBER BUT HIGHER DIOPTER POWER (16.5) LENS. IT WAS LEARNED THAT THE SUSPECT PRODUCT WAS DISCARDED. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. THE PATIENT WAS WELL POST-OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10998890 ↗
• InjuryAug 11, 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 OPERATIVE EYE DUE TO A 2 DIOPTER MYOPIC SURPRISE. AFTER REPEATING THE BIOMETRY TESTING, THE SURGEON GOT A POST-OPERATIVE AXIAL LENGTH (AL) BY IOL-MASTER AS 27.48 (AND SIMILAR BY POST-OP A-SCAN), WHEREAS A PRE-OP AL BY AMPLITUDE SCAN (A-SCAN) WAS 26.39. THE PATIENT IS A SYMMETRIC EITHER WAY WITH THE AL OF THE CONTRALATERAL EYE BEING 25.53. POSTERIOR STAPHYLOMA AT THE NERVE MAY HAVE ADDED TO THE ISSUE WITH A-SCAN ACCURACY. THE DIFFERENCE IN PREDICTED REFRACTIVE OUTCOME IS ABOUT 2 DIOPTERS AND IS WHAT THEY TESTED IN THE PHOROPTER (PUSHING PLUS). THROUGH FOLLOW-UP, IT WAS LEARNED THAT THERE WAS NO VITRECTOMY OR SUTURES REQUIRED. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND LOWER DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS STABLE AND UNAIDED VISUAL ACUITY (VA) HAS MARKEDLY IMPROVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10393947 ↗
• InjuryJun 2, 2020Break; Break

  IT WAS REPORTED THAT AFTER INSERTING THE INTRAOCULAR LENS (IOL) INTO THE PATIENT¿S LEFT EYE, A CRACK WAS OBSERVED ON THE IOL. THE IOL WAS REMOVED AND REPLACED WITHIN THE SAME PROCEDURE. THE INCISION WAS SLIGHTLY ENLARGED APPROXIMATELY 5MM. ONE SUTURE WAS USED. THERE WAS NO PATIENT INJURY REPORTED AND THE PATIENT POSTOP IS 20/20+1. BUT HE DOES NOT SEE AS WELL AS HE WANTED TO UP CLOSE. HE¿S AT J13. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10107562 ↗
• InjuryMay 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE BILATERAL INTRAOCULAR LENS (IOL) IMPLANTS. THE PATIENT IS EXPERIENCING LIGHT SENSITIVITY, AND HALOS AT NIGHT. ADDITIONALLY, WHEN USING THE COMPUTER, THE PATIENT EXPERIENCES DIZZINESS AND FLUTTER. THE PATIENT EXPLAINED THAT HIS SYMPTOMS ARE IN BOTH EYES AND THEY BEGAN IN LATE (B)(6) 2020. THROUGH FOLLOW-UP IT WAS LEARNED THE PATIENT IS NOT TAKING ANY MEDICATION FOR HIS SYMPTOMS. THE PATIENT¿S EYES ARE LIGHT BLUE. THE PATIENT EXPLAINED THAT HE HAS ALWAYS BEEN SENSITIVE TO LIGHT EVEN BEFORE THE IOLS WERE IMPLANTED. PRIOR TO THE LENS IMPLANTS, LIGHT FROM HIS BEDROOM WINDOW BOTHERED HIM EVEN WITH HIS EYES CLOSED. HE MUST PUT A PILLOW OVER HIS FACE. HE CAN¿T WATCH TELEVISION IN THE DARK, HE MUST TURN ON ALL THE LIGHTS. ALSO, WHEN HE WORKS ON HIS COMPUTER AND THEN GETS UP AND GOES TO THE KITCHEN, THE LIGHTS IN THE KITCHEN MAKE HIM DIZZY. HE HAS LED LIGHTS THROUGHOUT HIS HOUSE WHICH HE NOW TURNS ALL THE WAY DOWN, THAT HELPS A LITTLE BIT. HIS LIGHT SENSITIVITY IS ABOUT 50% MORE THAN IT WAS BEFORE AND IS IMPACTING HIS DAILY LIFE. HOWEVER, THE PATIENT REPORTS HE IS VERY HAPPY WITH HIS EYESIGHT AND HIS EYESIGHT IS GOOD. THE FLUTTERING IN HIS EYES

  Patient problems: Dizziness; Halo; Visual Disturbances

  MAUDE report 10090548 ↗
• InjuryFeb 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZXR00 +15.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE ON (B)(6) 2018 AND EXPLANTED ON (B)(6) 2019 BY A DIFFERENT SURGEON. THE REASON FOR THE EXPLANT WAS AN HYPEROPIC OUTCOME WITH ASTIGMATISM. THERE WAS NO PATIENT INJURY AND NO OTHER MEDICAL OR SURGICAL INTERVENTION PLANNED OR PERFORMED. A ZXR00 +15.0 DIOPTER WAS IMPLANTED AS A REPLACEMENT. THE PATIENT WAS REPORTED BEING HAPPY AND THE SYMPTOMS HAVE RESOLVED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Code Available

  MAUDE report 8353230 ↗
• InjuryFeb 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS UNHAPPY WITH THE READING AND DISTANCE VISION AFTER THE IMPLANTATION OF +15.0 DIOPTER MODEL ZXR00 TECNIS MULTIFOCAL IOL (INTRAOCULAR LENS) IN HER LEFT EYE (OS). AS A RESULT, LENS WAS EXPLANTED AND REPLACED WITH +17.0 DIOPTER ZXR00 LENS. PATIENT WAS SEEN AT 6-WEEK POSTOP VISIT AND WAS SATISFIED WITH THE RESULT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8324639 ↗
• InjuryJan 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 15.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2019 BECAUSE THE PATIENT ENDED UP MYOPIC. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 13.5. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8269736 ↗
• InjuryOct 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT, THAT SHE IS EXPERIENCING GLARE WHEN DRIVING AT NIGHT AFTER IMPLANTATION OF MODEL ZXR00 TECNIS SYMFONY MULTIFOCAL IOL'S (INTRAOCULAR LENS) IN BOTH EYES. HER DOCTOR RECOMMENDED AMBER COLORED SUNGLASSES, BUT THE ISSUE CONTINUES TO PERSIST. PATIENT REPORTED SHE DIDN'T START DRIVING AT NIGHT RIGHT AWAY BECAUSE IT GOT DARK LATE BUT SHE STARTED DRIVING SOON AFTER THE IMPLANTS. THE GLARE HAS AFFECTED HER ABILITY TO DRIVE AT NIGHT AND SHE IS CONCERNED ABOUT HER ABILITY TO DRIVE ONCE IT STARTS GETTING DARK EARLIER IN THE FALL. THERE IS NO INDICATION OF A PLANNED OR PERFORMED TREATMENT AT THIS TIME. THE LENSES REMAIN IMPLANTED. PATIENT STATED SHE WAS INFORMED BY THE DOCTOR THAT THERE WAS A RISK OF GLARE BUT SHE WANTED THE SYMFONY LENSES. PATIENT STATED THAT IF SHE HAD TO DO THE IMPLANTS AGAIN, SHE WOULD STILL GET THE SAME LENSES. SHE IS HAPPY WITH HER VISION. PATIENT HAD BILATERAL LENS IMPLANTS, THIS REPORT PERTAINS TO THE RIGHT EYE (OD).

  Patient problems: No Code Available

  MAUDE report 7936717 ↗
• InjuryOct 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT, THAT SHE IS EXPERIENCING GLARE WHEN DRIVING AT NIGHT AFTER IMPLANTATION OF MODEL ZXR00 TECNIS SYMFONY MULTIFOCAL IOL'S (INTRAOCULAR LENS) IN BOTH EYES. HER DOCTOR RECOMMENDED AMBER COLORED SUNGLASSES, BUT THE ISSUE CONTINUES TO PERSIST. PATIENT REPORTED SHE DIDN'T START DRIVING AT NIGHT RIGHT AWAY BECAUSE IT GOT DARK LATE BUT SHE STARTED DRIVING SOON AFTER THE IMPLANTS. THE GLARE HAS AFFECTED HER ABILITY TO DRIVE AT NIGHT AND SHE IS CONCERNED ABOUT HER ABILITY TO DRIVE ONCE IT STARTS GETTING DARK EARLIER IN THE FALL. THERE IS NO INDICATION OF A PLANNED OR PERFORMED TREATMENT AT THIS TIME. THE LENSES REMAIN IMPLANTED. PATIENT STATED SHE WAS INFORMED BY THE DOCTOR THAT THERE WAS A RISK OF GLARE BUT SHE WANTED THE SYMFONY LENSES. PATIENT STATED THAT IF SHE HAD TO DO THE IMPLANTS AGAIN, SHE WOULD STILL GET THE SAME LENSES. SHE IS HAPPY WITH HER VISION. PATIENT HAD BILATERAL LENS IMPLANTS, THIS REPORT PERTAINS TO THE LEFT EYE (OS).

  Patient problems: No Code Available

  MAUDE report 7936290 ↗
• InjurySep 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE ON (B)(6) 2018 WHICH RESULTED IN AN UNEXPECTED RESIDUAL REFRACTIVE ERROR. THE IOL WAS EXPLANTED ON (B)(6) 2018 AND A COMPETITOR IOL WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO VITRECTOMY, NO INCISION ENLARGEMENT AN NO SUTURES USED. THE PATIENT WAS DOING GOOD POST-OP. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7901221 ↗
• InjurySep 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS EXPERIENCING BLURRED VISION AT BOTH DISTANCE AND NEAR AND DEPTH PERCEPTION WAS OFF TOO. PATIENT WAS UNHAPPY AND COULD NOT FUNCTION DUE TO POOR VISION. THESE SYMPTOMS SIGNIFICANTLY INTERFERED WITH ACTIVITIES OF DAILY LIFE. THE LENS WAS EXPLANTED AND REPLACED WITH A NON-JOHNSON AND JOHNSON LENS. THERE WAS NO PATIENT INJURY REPORTED. THE LENS WAS DISCARDED BY THE SURGERY CENTER. NO ADDITIONAL INFORMATION PROVIDED. THIS REPORT PERTAINS TO LEFT EYE (OS).

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7900237 ↗
• InjurySep 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00, +15.0 DIOPTER) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE. REPORTEDLY, THE EXPLANT WAS DUE TO MALFUNCTION OF THE LENS. THE REPLACEMENT LENS WAS A MODEL ZCB00 +15.0 DIOPTER. PATIENT WAS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7892267 ↗
• InjurySep 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 15.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON AN UNKNOWN IMPLANT DATE. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT COMPLAINED OF ''GHOSTING'' WHEN WATCHING TV AND AN IMBALANCE BETWEEN BOTH EYES DUE TO A MYOPIC OUTCOME IN THE LEFT EYE. THERE WAS AN INCISION ENLARGEMENT MADE AND SUTURES USED. THE REPLACEMENT LENS WAS A ZXT150 12.5 DIOPTER LENS. REPORTEDLY, THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 7847987 ↗
• InjuryAug 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 15.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 FOR UNKNOWN REASONS. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS A ZKB00 15.0 LENS AND THE PATIENT IS DOING GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7833801 ↗
• InjuryAug 28, 2017Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available; Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL ZXR00 15.0 DIOPTER, WAS EXPLANTED ON (B)(6) 2017, BECAUSE OF AN UNSPECIFIED LENS MALFUNCTION. THE LENS WAS REPLACED WITH THE SAME MODEL, A SMALLER, 13.5 DIOPTER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6826071 ↗
• InjuryJul 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 15.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED. THE IOL WAS DESTROYED AND WILL NOT BE RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6720372 ↗
• InjuryApr 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PHYSICIAN IS PLANNING ON EXPLANTING A SYMFONY LENS FROM A PATIENT'S RIGHT EYE (OD). THE FEMALE PATIENT HAS LOUSY VISION IN BOTH EYES. THE PHYSICIAN WILL PROCEED WITH EXPLANTING THE OD FIRST. PATIENT'S VISUAL ACUITY IN THE RIGHT EYE IS J16. THE PATIENT HAS LOUSY VISION IN THEIR LEFT EYE, J10. THE DOCTOR IS PLANNING ON AN EXPLANT OF THIS LENS AS WELL. AT THIS TIME, A DATE FOR THE LENS EXPLANTS HAS NOT BEEN SCHEDULED. THIS REPORT REPRESENTS THE LENS IMPLANTED IN THE PATIENT'S RIGHT EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6532122 ↗
• InjuryFeb 13, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A MALE PATIENT'S RIGHT EYE DUE TO THE PATIENT BEING HYPEROPIC. AN INCISION ENLARGEMENT WAS REQUIRED. THE LENS WAS REPLACED WITH THE SAME MODEL LENS, A LARGER 16.5 DIOPTER LENS. THERE WAS NO PATIENT INJURY POST OP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6327488 ↗