TECNIS IOL ZXT375 (REF ZXT375U215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474607002), received between Sep 26, 2017 and Sep 3, 2020 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER ACCOUNT REPORTED THAT AFTER IMPLANTATION OF A TECNIS SYMFONY TORIC INTRAOCULAR LENS (IOL)IN THE PATIENT''S RIGHT (OD) EYE, THE PATIENT HAD BEEN SEEN BY THE SURGEON 21 TIMES. THE PATIENT REPORTED ISSUES WITH SEVERE HALOS AND GLARES. THE PATIENT WAS PRESCRIBED READING GLASSES WAS GIVEN ALPHAGAN DROPS TO LOWER PRESSURE BY ALLOWING BETTER FLUID DRAINAGE FROM WITHIN THE EYE AND TO PREVENT THE PUPILS FROM DILATING. THIS WOULD HELP REDUCE THE HALOS AND GLARES DURING NIGHT DRIVING. IN ADDITION, THE PATIENT HAS BEEN GIVEN CONTACT LENS TRIALS MULTIPLE TIMES TO IMPROVE THE NEAR VISION. A YTTRIUM ALUMINUM GARNET (YAG) LASER TREATMENT WAS DONE IN (B)(6) 2019. IT WAS NOTED THAT THE LENS REMAINS IMPLANTED. POST SURGERY, BOTH EYES ARE 20/25 J2, DISTANCE IS 20/20 OR 20/25 DEPENDING ON THE DAY. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT REPRESENTS THE RIGHT (OD) EYE. A SEPARATE REPORT IS SUBMITTED FOR THE LEFT (OS) EYE.

  Patient problems: Halo; No Code Available

  MAUDE report 10492257 ↗
• InjuryApr 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE BECAUSE OF THE PATIENT EXPERIENCING DYSPHOTOPSIA AND ANISOMETROPIA. THE REPLACEMENT LENS USED IS A SAME MODEL BUT LOWER DIOPTER (17.5) LENS. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 9942155 ↗
• InjuryOct 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS SYMFONY TORIC INTRAOCULAR LENS (MODEL ZXT375 +21.5 DIOPTER) WAS EXPLANTED FROM PATIENT RIGHT EYE IN SECONDARY SURGICAL PROCEDURE BECAUSE OF PATIENT EXPERIENCING INTRAOCULAR LENS POWER MISS DUE TO PREVIOUS LASIK. REPORTEDLY LENS WITH MODEL ZXR00 AND LOWER DIOPTER OF +18.0 WAS USED AS REPLACEMENT FOR THE PATIENT. PATIENT HAS REPORTEDLY RECOVERED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9184148 ↗
• InjuryApr 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZXT375 21.5 DIOPTER INTRAOCULAR LENSES (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) ON (B)(6) 2019. PATIENT COMPLAINS OF BEING VERY BOTHERED BY STARBURSTS THAT ARE CAUSING HIM DIFFICULTY DRIVING. IT WAS ALSO REPORTED THE STARBURST SYMPTOMS DO INTERFERE WITH DAILY ACTIVITIES. THE IOL REMAINS IMPLANTED IN THE PATIENT¿S EYE. AT THIS TIME THERE ARE NO PLANS FOR ANY SURGICAL OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION. THE PATIENT HAS BILATERAL LENS IMPLANTS. THE REPORT CAPTURES THE IOL IMPLANTED IN THE PATIENT'S OCULAR DEXTER - RIGHT EYE. A SEPARATE REPORT WILL BE FILED FOR THE PATIENT'S LEFT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 8489748 ↗
• InjurySep 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MULTIFOCAL TORIC INTRAOCULAR LENS (MODEL ZXT375, +21.5 DIOPTER) WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE FROM THE RIGHT EYE OF A (B)(6) MALE PATIENT BECAUSE OF RETINA ISSUES. ADDITIONAL INFORMATION WAS RECEIVED AND THE ACCOUNT COMMENTED THAT THERE WAS NO PRODUCT QUALITY ISSUE. THE LENS WAS EXPLANTED BECAUSE THE PATIENT HAD ACUTE ONSET OF MACULAR DEGENERATION. THE INCISION WAS ENLARGED TO REMOVED THE LENS AND SUTURES WERE USED. NO VITRECTOMY WAS PERFORMED AND NO SERIOUS PATIENT INJURY WAS REPORTED. A MONOFOCAL LENS (MODEL Z9002, +21.0 DIOPTER) WAS IMPLANTED AS A REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6892936 ↗