TECNIS IOL ZXR00 (REF ZXR00U0265)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474579224), received between Nov 21, 2016 and Nov 16, 2018 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZXR00 26.5 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE OF A MYOPIC MISS. THERE WAS NO INCISION ENLARGEMENT AND NO VITRECTOMY, BUT SUTURES WERE USED. THE REPLACEMENT LENS WAS A ZLB00 23.0 DIOPTER LENS. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8077077 ↗
• MalfunctionJun 19, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DEBRIS WAS NOTED TO BE EMBEDDED IN THE INTRAOCULAR LENS, AFTER INSERTION INTO THE PATIENT'S OPERATIVE EYE. THE LENS WAS CUT AND REMOVED. THERE WAS NO PATIENT INJURY AND NO INCISION ENLARGEMENT. ANOTHER LENS OF THE SAME MODEL AND DIOPTER WAS IMPLANTED SUCCESSFULLY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7613090 ↗
• InjuryApr 25, 2018Scratched Material; Scratched Material

  IT WAS REPORTED THAT TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00 +26.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE BECAUSE OF PATIENT EXPERIENCING VISUAL DISTURBANCE AND DOCTOR NOTICING A SCRATCH ON THE LENS POST IMPLANT. THE LENS WAS REPLACED WITH A LENS OF THE SAME MODEL AND SAME DIOPTER. NO INCISION ENLARGEMENT, NO SURGICAL INTERVENTION, NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7457269 ↗
• InjurySep 21, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXR00 26.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED ON (B)(6) 2017 DUE TO THE POST-OPERATIVE MYOPIC OUTCOME. THE LENS WAS REPLACED WITH THE SAME MODEL, BUT DIFFERENT DIOPTER (25.0). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6884384 ↗
• InjurySep 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 26.5 DIOPTER INTRAOCULAR LENS WAS IMPLANTED ON (B)(6) 2017. THERE IS A PLANNED EXPLANT ON (B)(6) 2017 DUE TO PATIENT EXPERIENCING TOO MUCH GLARE. NO ADDITION INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 6856655 ↗
• InjuryJun 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 26.5 DIOPTER INTRAOCULAR LENS (IOL) IS SCHEDULED TO BE EXPLANTED FROM A PATIENT'S RIGHT EYE DUE TO A MISSED REFRACTION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6616948 ↗
• InjuryNov 21, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON SEPTEMBER 21, 2016, IT WAS REPORTED THAT THERE WAS A LARGE MYOPIC MISS WITH A ZXR00 SYMFONY INTRAOCULAR LENS IMPLANTED IN PATIENT'S LEFT EYE. POST OP SPHERICAL EQUIVALENT WAS -2.00. PATIENT'S LEFT EYE VISION WAS REPORTED AS FOLLOWS - 20/80 DISTANCE, 20/20 INTERMEDIATE, 20/20 NEAR . PATIENT'S RIGHT EYE WAS SCHEDULED FOR IMPLANT ON (B)(6) 2016. REPORTEDLY, A ZXR00 SYMFONY LENS IMPLANTED IN PATIENT'S RIGHT EYE WAS SPOT ON; THE DOCTOR HAS DEVELOPED HIS OWN SURGEON FACTOR WITH TECNIS LENSES. A CALCULATION FOR OFFSET IN PATIENT'S RIGHT EYE WAS DONE BASED ON MYOPIC MISS OF LEFT EYE AND THE PATIENT ENDED UP PLANO BASED ON THE CALCULATION. AT ONE DAY POST-OP, THERE WAS NO ISSUE WITH THE RIGHT EYE. AT TWO WEEKS POST-OP, THE SECOND EYE VISION WAS PLANO (DISTANCE 20/20, INTERMEDIATE 20/20, NEAR 20/20); HOWEVER, THE PATIENT IS COMPLAINING OF HALO/GLARE IN THE RIGHT EYE. ON (B)(6) 2016, IT WAS REPORTED THAT THE DOCTOR IS TRYING TO DETERMINE IF REMOVING THE LEFT EYE IMPLANT AND REPLACING WITH A LOWER POWER WOULD HELP PATIENT WITH THE SIDE EFFECTS. ON (B)(6) 2016, IT WAS REPORTED THAT THE LEFT EYE EXPLANT IS SCHEDULED FOR (B)(6) 2016. ON (B)(6) 2016, IT WAS REPORTED THAT THE LEFT EYE LENS WAS E

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 6118702 ↗