TECNIS IOL ZXT375 (REF ZXT375U200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474606975), received between Mar 15, 2017 and Oct 4, 2019 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FORMER STUDY PATIENT UNDERWENT EXPLANT OF A MODEL ZXT375 20.0 DIOPTER INTRAOCULAR LENS (IOL), FROM THE RIGHT EYE (OD) DUE TO HALOS AND GLARE CAUSING DIFFICULTY WITH DRIVING AT NIGHT. THE EXPLANT/EXCHANGE WAS CONDUCTED AFTER THE PATIENT EXITED THE STUDY. THE REPLACEMENT LENS WAS A MODEL ZCT300 20.0 DIOPTER. THE PATIENT IS NOTED TO BE RECOVERING. THE EXPLANTED LENS WAS DISCARDED AND IS UNAVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 9159304 ↗
• InjuryApr 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZXT375 MULTIFOCAL IOL (INTRAOCULAR LENS) WAS IMPLANTED ON (B)(6) 2018 IN THE PATIENT'S RIGHT EYE (OD). REPORTEDLY, THE LENS WAS PLANNED TO BE EXPLANTED ON (B)(6) 2019 . THE REASON OF THE EXPLANT IS UNKNOWN, NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8469261 ↗
• MalfunctionMar 29, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE HAPTIC OF THE INTRAOCULAR LENS TORE WHILE INSERTING INTO THE PATIENT'S OPERATIVE EYE. REPORTEDLY, THE LENS WAS INSERTED AND REMOVED DURING THE SAME SURGICAL PROCEDURE. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES USED. THE PATIENT WAS REPORTED DOING GOOD POST-OP. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8464285 ↗
• InjuryFeb 27, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZXT375 INTRAOCULAR LENS (IOL) ROTATED AFTER BEING IMPLANTED IN A PATIENT. THE PATIENT IS SCHEDULED TO GO BACK TO THE OR (B)(6) FRIDAY, (B)(6) 2019. THE DOCTOR IS REQUESTING GUIDANCE WHILE HE DOES THE LENS REPOSITIONING. IT WAS LEARNT THAT THE INTENDED AXIS PLACEMENT OF THIS IOL WAS AT 7 DEGREES AND IT¿S CURRENTLY SITTING AT 18 DEGREES. NOT SURE IF THIS LENS ACTUALLY ROTATED POST OP OR WAS OFF AXIS FROM THE BEGINNING. THE PROBLEM IS PATIENT CURRENTLY HAS DENSE POSTERIOR CAPSULE OPACIFICATION (PCO). THE PCO ITSELF CAN CONTRIBUTE TO THE REFRACTIVE ASTIGMATISM SO HENCE THE CONUNDRUM. IT WAS STATED THAT THE PATIENT HAS 2.75 DIOPTER OF ASTIGMATISM. PATIENT DID HAVE DRY EYE ISSUES BUT THE DOCTOR SUCCESSFULLY TREATED PRIOR TO BIOMETRY AND SURGERY WITH XIIDRA, PUNCTUM PLUGS AND TEARS. IT WAS ALSO NOTED THAT THE VISUAL SYMPTOMS SIGNIFICANTLY INTERFERE WITH THE PATIENT¿S REGULAR ACTIVITIES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Dry Eye(s); No Code Available

  MAUDE report 8376028 ↗
• InjuryDec 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT375 20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 BECAUSE THE PATIENT COULD NOT SEE CLEARLY. THERE WAS NO INCISION ENLARGEMENT OR VITRECTOMY PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available; Visual Impairment

  MAUDE report 7088888 ↗
• InjuryJun 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT REPORTED THAT A DOCTOR WILL BE PERFORMING AN EXPLANT OF A MODEL ZXT375 20.0 DIOPTER INTRAOCULAR LENS (IOL) FROM THE RIGHT EYE (OD) OF A MALE PATIENT ON (B)(6) 2017 DUE TO PATIENT COMPLAINTS OF INTOLERABLE NIGHT TIME DYSPHOTOPSIA. THE PATIENT CURRENTLY HAS BILATERAL SYMFONY LENSES AND THE DOCTOR''S SURGICAL PLAN IS TO EXPLANT ONLY ONE EYE AT THE MOMENT AND REPLACE THE LENS WITH A TORIC LENS, MODEL ZCT450, 20.0 DIOPTER THAT WILL BE PRESCRIBED FOR DISTANCE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE LENS WILL NOT BE RETURNED AS IT WAS DISCARDED POST EXPLANATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 6659433 ↗
• InjuryMar 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT375 20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A FEMALE PATIENT'S LEFT EYE DUE TO AN UNEXPECTED POST-OP REFRACTION. THIS LENS WAS REMOVED AND REPLACED WITH A ZXR00 20.5 DIOPTER IOL. ADDITIONALLY, THERE WAS NO INCISION ENLARGEMENT REQUIRED.

  Patient problems: No Code Available

  MAUDE report 6408184 ↗