TECNIS IOL ZXR00 (REF ZXR00U0270)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474579231), received between May 20, 2018 and Sep 30, 2022 — classified as 8 injuries.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH AN INTRAOCULAR LENS (IOL) IN THE RIGHT EYE IS COMPLAINING OF DIFFICULTY DRIVING AT NIGHT AND READING ROAD SIGNS AND HALOS ON POST-OPERATIVE DAY 7. DAILY ACTIVITIES SIGNIFICANTLY AFFECTED. VISION PRE-OPERATIVE (OP): 20/30 AND VISION POST-OP 20/40. IT WAS INITIALLY REPORTED THAT THE LENS WAS PARTIALLY INSERTED, BUT PATIENT IS FORECASTED FOR A PLANNED EXPLANT. THE PATIENT STATUS WAS REPORTED AS TEMPORARILY IMPAIRED. THROUGH FOLLOW-UP, IT WAS CLARIFIED THAT THE LENS WAS FULLY IMPLANTED AND THAT THE EXPLANT WAS PERFORMED IN A SECONDARY PROCEDURE. THE LENS WAS DISCARDED. IT WAS CLARIFIED THAT THE PATIENT'S DAILY ACTIVITY THEY COULD NOT PERFORM WAS DRIVING. THE MEDICATION PRESCRIBED WAS STANDARD OF CARE DROPS AFTER SURGERY. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED AND NO DELAY IN PROCEDURE REPORTED. ANOTHER JOHNSON & JOHNSON LENS, MODEL ZXR00 25.5 DIOPTER WAS SUCCESSFULLY IMPLANTED AS A REPLACEMENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 15515224 ↗
• InjuryMar 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 IOL 27.0 DIOPTER WAS IMPLANTED IN THE PATIENT¿S RIGHT EYE. THE PATIENT IS EXPERIENCING TOO MUCH GLARE IN BOTH EYES AND WANTS THE LENS EXPLANTED AND REPLACED WITH A STANDARD LENS. NO FURTHER INFORMATION WAS PROVIDED. THE LEFT EYE IS CAPTURED IN A SEPARATE MEDWATCH REPORT.

  Patient problems: No Code Available

  MAUDE report 9891691 ↗
• InjuryOct 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS SYMFONY INTRAOCULAR LENS (MODEL ZXR00 +27.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE BECAUSE OF PATIENT EXPERIENCING BLURRY VISION, VISION WAS NOT SHARP. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES AND NO VITRECTOMY REQUIRED. LENS WITH SAME MODEL, BUT LOWER DIOPTER OF +25.5 WAS USED AS REPLACEMENT FOR THE PATIENT. VISUAL ACUITY PRE-OP: BEFORE SX (SURGERY)-BCVA (BEST CORRECTED VISUAL ACUITY): 20/30 VISUAL ACUITY POST OP: AFTER 1ST SC (SANS CORRECTIO) UCDVA UNCORRECTED VISUAL ACUITY): 20/50 NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9248506 ↗
• InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 INTRAOCULAR LENS (IOL) WAS IMPLANTED IN 2018. THE PATIENT DEVELOPED COMPLAINT OF RINGS, INABILITY TO DRIVE AT NIGHT. VARIOUS GLASSES/CONTACT LENSES TRIED TO RESOLVE THE ISSUE BUT WITHOUT SUCCESS. THE ZXROO LENS WAS EXPLANTED AND WAS REPLACED WITH A MONOFOCAL LENS. THIS REPORT CAPTURES THE EVENT FOR THE LEFT EYE. A SEPARATE REPORT IS BEING SUBMITTED FOR THE RIGHT EYE. FOLLOW-UP NOTED THAT NO PRODUCT IS COMING BACK FOR THIS EVENT. THE CONTACT PERSON DOESN'T KNOW DATE OF WHEN THE VISUAL ISSUES 1ST OCCURRED. HOWEVER, THE CONTACT PERSON CONFIRMED THAT THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES PERFORMED. PATIENT WAS WELL POST-OP. NO OTHER INFORMATION WAS RECEIVED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 8952830 ↗
• InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO BLURRY VISION, DESCRIBED AS DIFFICULTY SEEING STREET SIGNS WITH SHADOWING ON PERIPHERAL VISION. THE PATIENT'S PRE-OP VISUAL ACUITY WAS 20/40. FOLLOW-UP CONFIRMED THAT THE PATIENT HAD VISUAL ACUITY OF 20/20 POST-OP DAY ONE. THE REPLACEMENT LENS MODEL WAS ZCB00 26.5 DIOPTER POWER. NO OTHER INFORMATION WAS RECEIVED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8952796 ↗
• InjuryDec 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 27.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT WAS NOT HAPPY WITH HER VISION DUE TO THE NEAR VISION BEING BLURRY AND HAVING SOME HALOS. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS A NON-JOHNSON AND JOHNSON LENS. REPORTEDLY, THE PATIENT IS DOING WELL POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 8163898 ↗
• InjuryJun 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DOCTOR REPORTED OF CONSIDERING AN EXPLANT IN THREE (3) MONTHS OF A ZXR00 27.0 DIOPTER INTRAOCULAR LENS (IOL) DUE TO THE SYMPTOMS THAT THE PATIENT IS EXPERIENCING. THE SYMPTOMS ARE FLICKERING WITH OVERHEAD FLUORESCENTS AND DAYLIGHT WHICH IS MAKING DRIVING AND DISTANCE VIEWING DIFFICULT FOR THE PATIENT. REPORTEDLY, THE PATIENT DOES NOT HAVE ANY CONTRIBUTING MEDICAL HISTORY AND NO MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED. THERE WAS NO PATIENT INJURY AND NO COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO PATIENT''S LEFT EYE (OS). A SEPARATE MDR REPORT IS BEING SUBMITTED FOR THE PATIENT''S RIGHT EYE (OD).

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7635696 ↗
• InjuryMay 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH ZXR00 27.0 DIOPTER INTRAOCULAR LENS (IOL) AND EXPERIENCED AN UNEXPECTED POST-OP OUTCOME. IT WAS NOTED THAT PRE-OP THE PATIENT WAS +3.75. TARGET WAS PLANO AND POST-OP IS -3.00. THE PATIENT ISN¿T UNHAPPY WITH THE RESULT BUT WANTS TO UNDERSTAND THE MISS BEFORE THE SECOND EYE SURGERY. AN EXACT DATE WAS NOT PROVIDED. PER MEDICAL REVIEW FOLLOW-UP IT WAS NOTED THAT THE PATIENT'S UNUSUAL EYE, SHORT AXIAL LENGTH AND STEEP KERATOMETRY WHICH CAN CAUSE UNCERTAINTY IN PREDICTING THE ESTIMATED LENS POSITION. THE PHYSICIAN WAS NOT SURE IF THE REFRACTION ACQUIRED WAS PUSHING-PLUS, SO IT WAS ADVISED TO REPEAT CAREFULLY A PUSHING-PLUS MANUAL REFRACTION TO DETERMINE THE AMOUNT OF MYOPIC ERROR. IT WAS ALSO DISCUSSED EVALUATING THE CAPSULAR BAG DISTENSION, PLATEAU IRIS, MALIGNANT GLAUCOMA, AS THESE FINDING CAN CAUSE THE LENS TO SIT FURTHER ANTERIORLY AS WELL. THE PHYSICIAN WILL BE SEEING THE PATIENT AGAIN FOR FURTHER EVALUATION. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7528589 ↗