TECNIS IOL ZXR00 (REF ZXR00U0120)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474591684), received between Aug 1, 2017 and Nov 26, 2019 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Scratched 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REACHED OUT TO JOHNSON & JOHNSON REQUESTING ASSISTANCE WITH A PATIENT REPORTING DIFFICULTY/COMPLAINING OF ¿DAY TIME GLARE¿ THAT IS RESULTING IN PATIENT SUFFERING WITH DAY TIME DRIVING. A REQUEST AND SUPPORT TO LOOK OVER THE CHARTS IN AN EFFORT TO ASSIST WITH IDENTIFYING CONCERNS AND FINDING A RESOLUTION. FURTHER INFORMATION NOTES PATIENT IS A HIGH MYOPE. PATIENT STATES HE IS NOT HAPPY WITH VISUAL ACUITY (VA) FOR DISTANCE WHEN DRIVING AT NIGHT DUE TO GLARE/HALOS. PATIENT IS NOT HAPPY WITH VA FOR NEAR OR INTERMEDIATE AT ALL. HE IS NOT HAPPY HAVING TO USE READERS EVEN THOUGH HE CAN SEE WITH OTC (OVER THE COUNTER) READERS. PATIENT THOUGHT HE WOULD NOT NEED TO WEAR GLASSES AT ALL. HE STATES HE WAS TOLD HE WOULD HAVE PERFECT VISION FOR NEAR AFTER SURGERY. CONSULTATION WAS PERFORMED AND DISCUSSION IS STILL ONGOING. THE PATIENT COMPLAINS BITTERLY OF GLARE WITH NO OBVIOUS SOURCE AND PATIENT IS RESISTING FURTHER EVALUATION. NO FURTHER INFORMATION WAS PROVIDED. PATIENT HAS BILATERAL LENS IMPLANTS; THIS REPORT REPRESENTS THE FIRST OF TWO LENS IMPLANTS.

  Patient problems: Halo; No Code Available

  MAUDE report 9374825 ↗
• InjuryOct 18, 2019Adverse 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 POWER MISS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9211225 ↗
• InjuryJul 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A MODEL ZXR00 12.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2019. THE LENS WAS EXPLANTED ON (B)(6) 2019 DUE TO COMPLAINT OF POOR POST-OP REFRACTION. IT WAS REPORTED THERE WAS NO INCISION ENLARGEMENT. NO ADDITIONAL INFORMATION PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 8761899 ↗
• InjuryMay 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT IS EXPERIENCING ISSUES WITH BILATERAL SYMFONY LENSES, HENCE THE SURGEON IS PLANNING ON BILATERAL EXPLANT IN A SECONDARY SURGICAL PROCEDURE. HOWEVER, THE EXPLANT HAS NOT YET BEEN CONFIRMED. THIS REPORT WILL CAPTURE INFORMATION FOR PATIENT¿S RIGHT EYE. A SEPARATE REPORT IS BEING SUBMITTED FOR PATIENT¿S LEFT EYE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8657054 ↗
• InjuryDec 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00, 12.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN A PATIENT WHO DEVELOPED HALO AND GLARE AT NIGHT. THE IOL WAS EXPLANTED AND REPLACED WITH A MONOFOCAL LENS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8144719 ↗
• InjuryApr 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS SYMFONY INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE LEFT EYE ON (B)(6) 2018. THE LENS WAS EXPLANTED DUE TO PATIENT COMPLAINTS OF GLARE, HALOS AND UNABLE TO DRIVE AT NIGHT. THE INCISION WAS ENLARGED TO 3.0MM. THE INTRAOCULAR LENS WAS REPLACED WITH A ZCBOO MODEL.

  Patient problems: Halo; No Code Available

  MAUDE report 7431289 ↗
• InjuryMar 5, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXR00 +12.0 DIOPTER) WAS EXPLANTED IN A SECONDARY PROCEDURE FROM PATIENT'S OPERATIVE EYE BECAUSE OF AN UNSPECIFIED LENS MALFUNCTION DIAGNOSIS. REPORTEDLY DURING THE EXPLANT PROCEDURE THE INCISION WAS ENLARGED AND A VITRECTOMY WAS REQUIRED. THE REPLACEMENT LENS WAS A TECNIS MONOFOCAL INTRAOCULAR LENS (MODEL ZA9003, +12.0 DIOPTER). PATIENT WAS REPORTED TO BE DOING GOOD WHEN DISCHARGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 7315512 ↗
• InjuryAug 28, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A TECNIS SYMFONY INTRAOCULAR LENS (IOL), MODEL ZXR00 12.0, WAS EXPLANTED ON (B)(6)2017, BECAUSE OF AN UNSPECIFIED LENS MALFUNCTION. THE LENS WAS REPLACED WITH A DIFFERENT MODEL, ZCB00 12.0 DIOPTER. PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6826136 ↗
• MalfunctionAug 1, 2017Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS INSERTED AND REMOVED AFTER NOTING A SCRATCH ON IT. NO FURTHER INCIDENT. THE IOL WAS FULLY INSERTED. NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURES, NO VITRECTOMY. PROCEDURE COMPLETED WITH A LENS OF THE SAME MODEL AND DIOPTER. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6759064 ↗