TECNIS IOL ZXR00 (REF ZXR00U0285)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474591769), received between Apr 4, 2017 and Aug 25, 2026 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Dent in Material” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem

  This report is to capture the right eye. It was reported that a Johnson and Johnson (JNJ) Intraocular lens (IOL) was implanted in the patient¿s left and right eye. The patient reported blurry vision. In their right eye the patient experienced starbursts and had post-operative laser surgery. In their left eye they see soft halos. The patient takes Thera Tears for her dry eyes. She has a doctor¿s appointment and plans on contacting us after her visit. The patient wants to know if this IOL was ever recalled. No further information was provided.

  Patient problems: Blurred Vision; Flashers

  MAUDE report 50438853 ↗
• InjuryJul 2, 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, +28.5 DIOPTER) WAS EXPLANTED FROM THE PATIENT¿S OPERATIVE EYE IN A SECONDARY PROCEDURE BECAUSE OF HALOS, GLARE AND NEAR VISION NOT WHAT THE PATIENT WANTED. THERE WAS NO PATIENT INJURY, NO VITRECTOMY OR OTHER SURGICAL INTERVENTION REQUIRED. PATIENT WAS REPORTED DOING WELL WHEN DISCHARGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 7654197 ↗
• MalfunctionMay 3, 2018Dent in Material; Dent in Material

  IT WAS REPORTED THAT THERE WAS DIMPLE ON THE LENS. THERE WAS NO PATIENT CONTACT REPORTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7484763 ↗
• InjuryMar 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 28.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018, BECAUSE THE PATIENT EXPERIENCED POOR VISION, NON-FOCUSING MOMENTS, LIGHT RING HALOS, GLARE, AND COULD NOT TOLERATE NIGHTTIME ISSUES, WHICH CAUSED AN INABILITY TO DRIVE. THE REPLACEMENT LENS WAS A PCB00 31.0 DIOPTER LENS. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; No Code Available; Visual Impairment

  MAUDE report 7322576 ↗
• InjuryNov 21, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A ZXR00 28.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE LEFT EYE (OS) ON (B)(6) 2017. REPORTEDLY, THE DOCTOR REPORTED THE LENS AS DECENTERED IN THE PATIENT'S LEFT EYE. THE PATIENT REFRACTS WELL AND CONTACT LENSES ARE HELPING. HOWEVER, IT WAS REPORTED THAT IT'S NOT IDEAL TO WEAR CONTACTS IF THERE IS ANOTHER OPTION SUCH AS REPOSITIONING THE LENS. CURRENTLY, THE PLAN IS TO FOLLOW UP WITH THE DOCTOR TO DISCUSS OPTIONS FOR RESOLUTION. FURTHERMORE, THE PATIENT'S CHART INDICATED THE PATIENT IS EXPERIENCING GLARE, TROUBLE READING, AND STRAINING. POST OP VISIT, ON DATE OF SERVICE (B)(6) 2017, INDICATED THE PATIENT'S REFRACTION AS -0.50 X +1.25 X 145 WITH A VISUAL ACUITY OF 20/20. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 7051421 ↗
• InjuryApr 4, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BILATERAL SYMFONY LENS IMPLANTS. AFTER IMPLANTATION OF A ZXR00 28.5 DIOPTER INTRAOCULAR LENS (IOL) ON A MALE PATIENT'S RIGHT EYE, IT RESULTED IN AN HYPEROPIC OUTCOME. THE LENS WAS REPLACED WITH A SMALLER DIOPTER, SAME LENS MODEL. THERE WAS NO VITRECTOMY OR INCISION ENLARGEMENT REQUIRED. THE DEVICE WAS DISCARD AND WILL NOT BE AVAILABLE FOR EVALUATION. VISUAL ACUITY AFTER INITIAL IMPLANT: REFRACTION +1.5-.75X 135, BEST CORRECTED 20/30, UCDVA (UNCORRECTED DISTANCE VISUAL ACUITY) 20/50, UCDVA J10. VISUAL ACUITY 10 DAYS POST-OP AFTER LENS EXCHANGE: 20/25 UCDVA, UCNVA (UNCORRECTED NEAR VISUAL ACUITY) 20/20, AR -.25 -.50 @87, REFRACTION PLANO 20/25. PATIENT ADDITIONALLY HAD A SYMFONY LENS IMPLANTED IN THEIR LEFT EYE. THERE ARE NO REPORTED ISSUES WITH THIS EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6459162 ↗