TECNIS IOL ZXT375 (REF ZXT375U185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474606944), received between Nov 16, 2016 and Jun 21, 2022 — classified as 8 injuries.

The most frequently reported specific device problem is “Incorrect Measurement” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 21, 2022Adverse 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 LEFT EYE FOR AN UNSPECIFIED REASON AND ANOTHER JOHNSON & JOHNSON ZCU LENS OF DIFFERENT MODEL AND 5.25 DIOPTER WAS USED AS THE REPLACEMENT. THERE WAS NO PATIENT INJURY NOR ANY MEDICAL OR SURGICAL INTERVENTIONS REQUIRED. THERE WAS NO ADVERSE EFFECTS OR COMPLAINTS POST-OPERATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort; Eye Injury

  MAUDE report 14758060 ↗
• InjuryFeb 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS FULLY IMPLANTED IN THE PATIENT'S LEFT EYE WHEN IT WAS NOTICED THE VITREOUS WAS LEAKING FROM THE EYE. THE IOL WAS REMOVED AND A VITRECTOMY WAS PERFORMED. THE PROCEDURE WAS COMPLETED WITH A 3-PIECE J&J LENS. THE REPLACEMENT LENS MODEL AND DIOPTER ARE UNKNOWN. THE CUSTOMER THINKS THIS IS A RESULT OF A NEW PHYSICIAN ACCIDENTALLY TEARING THE BAG. REPORTEDLY, THERE WAS NO PATIENT INJURY. THROUGH FOLLOW-UP THE CUSTOMER CONFIRMED THERE WAS A CAPSULE TEAR AND NO SUTURES WERE REQUIRED. NO MEDICATIONS OUTSIDE THE REGULAR STANDARD OF CARE WERE PRESCRIBED. THE CUSTOMER ALSO STATED THE PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 13578411 ↗
• InjuryAug 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT375 18.5 DIOPTER LENS WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE DUE TO THEM EXPERIENCING NIGHT TIME HALOS. THE REPLACEMENT LENS IS A ZCT400 18.5 DIOPTER LENS. NO COMPLICATIONS OF ANY KIND WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 8932187 ↗
• InjuryMay 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT375 18.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO INCORRECT POWER ISSUE AT 1 DAY POST-OP. IN FOLLOW-UP NO SPECIFICS REGARDING PATIENT VISUAL ISSUES WERE PROVIDED. THE REPLACEMENT LENS WAS A ZXT300, 18.5 DIOPTER. REPORTEDLY, PATIENT IS DOING FINE POST-SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8656023 ↗
• InjuryMay 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DOCTOR IS PLANNING TO EXPLANT TECNIS SYMPHONY TORIC MULTIFOCAL INTRAOCULAR LENS (MODEL ZXT375, +18.5 DIOPTER) FROM PATIENT¿S LEFT EYE IN SECONDARY PROCEDURE BECAUSE OF PATIENT EXPERIENCING REFRACTIVE ERROR. REPORTEDLY, THE EXPLANT HAS NOT YET BEEN PERFORMED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7509325 ↗
• InjuryAug 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT375 18.5 DIOPTER WAS IMPLANTED INTO THE RIGHT EYE (OD) ON (B)(6) 2017. POST-OPERATIVELY, THE PATIENT COMPLAINED OF NOT BEING ABLE TO SEE, HAVING AN UNEXPECTED REFRACTIVE ERROR, AND ASTIGMATISM. THEREFORE, THE PATIENT WANTED TO HAVE THE LENS EXPLANTED. AN EXPLANT WAS PERFORMED ON (B)(6) 2017, AND REPLACED WITH A NON-AMO LENS. THE LENS EXCHANGE WENT WELL, THERE WERE NO COMPLICATIONS, NO ADDITIONAL PROCEDURES REQUIRED, AND THE PATIENT IS DOING FINE. MANIFEST REFRACTION PRIOR TO SYMFONY LENS IMPLANT: SPHERE: -6.50 CYLINDER: +3.00 AXIS: 070 ADD: +2.25 MANIFEST REFRACTION AFTER SYMFONY LENS IMPLANT: SPHERE: -2.00 CYLINDER: +2.75 AXIS: 040 ADD: +2.50 NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6829256 ↗
• InjuryJun 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ZXT375 18.5 DIOPTER INTRAOCULAR LENS WAS EXPLANTED FROM A MALE PATIENT'S LEFT EYE DUE TO A RESIDUAL REFRACTIVE ERROR. THE LENS WAS EXPLANTED WITH NO COMPLICATION, NO INJURY AND NO ADDITIONAL PROCEDURES. THE LENS WAS REPLACED WITH THE SAME MODEL LENS WITH A HIGHER DIOPTER. PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6681326 ↗
• InjuryNov 16, 2016Incorrect Measurement; Appropriate Device Problem Term/Code Not Available; Incorrect Measurement; Appropriate Device Problem Term/Code Not Available

  IT WAS INITIALLY REPORTED THAT THE DOCTOR LIKES THE LENS AND HAS HAD SUCCESS WITH OTHER PATIENTS WITH THE LENS BUT WAS PLANNING TO EXPLANT THE LENS AS THE AXIS HAS BEEN FLIPPED ON THIS MALE PATIENTS LEFT EYE, RESULTING IN 1.5D OF RESIDUAL CYLINDER. HE MENTIONS HIS WOUND DOES NOT CREATE A LARGE ASTIGMATISM SHIFT, BUT THE PRE-OP PENTACAM MAY HAVE SHOWN SOME ARTIFACT ASTIGMATISM. HE BELIEVES USING THE SYMFONY TORIC CALCULATOR WHEN PICKING THE CYLINDER CORRECTION POWER WOULD HAVE BEEN BENEFICIAL. HE WILL REPLACE THIS SYMFONY TORIC WITH A TECNIS TORIC LENS. FURTHER INFORMATION CONFIRMED THE EXPLANT DID OCCUR DUE TO THE TORIC AXIS FLIPPED. THE PHYSICIAN PICKED THE WRONG CYLINDER CORRECTION POWER BECAUSE HE DID NOT USE THE TORIC CALCULATOR. ADDITIONALLY, THE PHYSICIAN NOTED THAT THE PATIENT HAD A 20/20 REFRACTION. THE PATIENT HAS RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6105094 ↗