TECNIS IOL ZXT375 (REF ZXT375U210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474606999), received between Nov 13, 2017 and Jun 12, 2020 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 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.

• MalfunctionJun 12, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED FOR A STUDY SUBJECT THAT TECNIS INTRAOCULAR LENS WAS IMPLANTED IN PATIENT¿S RIGHT EYE AND THE LENS WAS PLACED AT AXIS 010. REPORTEDLY ,THERE WAS AXIS MISALIGNMENT OF 13 DEGREES WITH TECNIS TORIC INTRAOCULAR LENS OBSERVED AT 6-MONTH VISIT WITH REPORTED AXIS PLACEMENT OF 177 IN PATIENT¿S RIGHT EYE. THERE ARE NO PLANS FOR SECONDARY SURGICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNED THAT PATIENT WAS EXPERIENCING NON-DIRECTED VISUAL SYMPTOMS LIKE FLOATERS IN THE RIGHT EYE. NO VISUAL SYMPTOMS REPORTED. SUBJECT HAS EXITED THE STUDY AND IS HAPPY. PRE-OP BEST CORRECTIVE VISUAL ACUITY (BCVA): 20/25 ¿ RIGHT EYE. PRE-OP BEST CORRECTIVE VISUAL ACUITY: 20/30 ¿ LEFT EYE. AT 6-MONTH VISIT UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA): 20/20 ¿ BOTH EYES. BEST CORRECTIVE DISTANCE VISUAL ACUITY: 20/20 ¿ BOTH EYES NO FURTHER INFORMATION PROVIDED.

  Patient problems: Vitreous Floaters

  MAUDE report 10148906 ↗
• InjuryDec 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT375 TECNIS SYMFONY 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 PATIENT NOT HAPPY WITH HIS VISION. THERE WAS NO SURGICAL INTERVENTION REQUIRED AND NO COMPLICATION HAS BEEN REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9450326 ↗
• InjuryAug 6, 2019Adverse 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 DUE TO BLURRY VISION WHERE THE PATIENT REPORTED FEELING UNCOMFORTABLE. THE LENS WAS REPLACED WITH A SAME MODEL, SAME DIOPTER LENS. THE PATIENT WAS REPORTED DOING GOOD, NO ISSUES POST-OP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available; Red Eye(s)

  MAUDE report 8867521 ↗
• InjuryJan 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS SYMFONY INTRAOCULAR LENS (IOL) (MODEL ZXT375 +21.0 DIOPTER) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE. IT WAS LATER EXPLANTED DUE TO UNEXPECTED POST OPERATIVE REFRACTION. THE SYMPTOMS WERE REPORTEDLY AFFECTING THE PATIENT'S DAILY ACTIVITIES. A MODEL ZCT400 +21.0 DIOPTER WAS USED AS A REPLACEMENT LENS FOR THE PATIENT AND THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7229910 ↗
• InjuryNov 13, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXT375 21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE (OS) ON (B)(6) 2017. POST-OPERATIVELY, THE PATIENT'S REFRACTION WAS -2.5 EVEN THOUGH THE OCULAR RESPONSE ANALYZER (ORA) SUGGESTED A 21.0 DIOPTER LENS. ALSO, THE DOCTOR STATED THEY WEREN'T ABLE TO OBTAIN A MEASUREMENT BEFORE SURGERY. HOWEVER, THE LENS DID CORRECT FOR ALL THE PATIENT'S ASTIGMATISM. THE LENS WAS EVENTUALLY EXPLANTED ON (B)(6) 2017 AND THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 19.0. THERE WAS AN INCISION ENLARGEMENT, BUT NO VITRECTOMY WAS PERFORMED AND NO SUTURES WERE USED. REPORTEDLY, THE PATIENT IS DOING GOOD POST-OPERATIVELY WITH A MYOPIC RESULT AND THERE WAS NO PATIENT INJURY. FURTHERMORE, THE PATIENT'S VISUAL ACUITY WAS 20/25. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7025259 ↗