TECNIS IOL ZXR00 (REF ZXR00U0290)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474591776), received between Nov 1, 2017 and Jun 20, 2018 — classified as 2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNINTENDED MYOPIA ON THE LEFT EYE (OS) DISABLING VISION, 19 DAYS POST-IMPLANTATION OF A ZXR00 INTRAOCULAR LENS (IOL) 29.0 DIOPTER. PER ACCOUNT, PATIENT HAD VISUAL DISTURBANCE AND THE OUTCOME SIGNIFICANTLY INTERFERED WITH HER DAILY ACTIVITIES. CONSEQUENTLY, THE IOL HAD TO BE EXPLANTED FROM PATIENT'S EYE. THE INCISION WAS ENLARGED TO REMOVE THE LENS. THE REPLACEMENT LENS WAS THE SAME MODEL SMALLER DIOPTER (+27.0). THE PATIENT CURRENT STATUS IS REPORTED AS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7619001 ↗
• InjuryNov 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT COMPLAINED THAT SHE NO LONGER SEES COLORS THE SAME SINCE HAVING CATARACT SURGERY ON HER LEFT (OS) EYE. THE PATIENT STATED THAT SHE NOW SEES RED AS FUCHSIA AND TAUPE AS PINK. SHE IS AN INTERIOR DESIGNER, SO COLOR IS IMPORTANT TO HER AND SHE STILL NEEDS TO HAVE A CATARACT PROCEDURE ON HER RIGHT EYE. SHE HAS AN APPOINTMENT ON (B)(6) 2017. THE DOCTOR IS THINKING OF JUST USING A STANDARD MONOFOCAL LENS. IT WAS REPORTED THAT THE PATIENT HAD RADIAL KERATOTOMY DONE IN HER LEFT EYE ON (B)(6) 2017 AND IS CURRENTLY USING AN ANTIINFLAMMATORY AND ANTI-BIOTIC EYE DROPS 3/DAY. THE PATIENT CAN SEE DISTANCE BUT IS HAVING TROUBLE READING. THE PATIENT MENTIONED THAT SHE CAN SEE THE RED COLOR BUT DEPENDING ON THE DIFFERENT SURFACES OR TEXTURE SHE SEES A DIFFERENT COLOR. FOR EXAMPLE, THE HOUSE NEXT TO HER IS TAUPE BUT SHE SEES IT AS PINK IN HER LEFT EYE. HOWEVER, COLORS ARE BRIGHTER THAN BEFORE. SHE ALSO MENTIONED HER PERIPHERAL VISION SEEMS CUT OFF. WHEN PATIENT CONSULTED WITH HER DOCTOR, HER DOCTOR MENTIONED TO HER THAT THIS MAY BE DUE TO THE WAY THE LENS IS SITTING IN THE EYE AND THE REFLECTION. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6994011 ↗