TECNIS IOL ZXT375 (REF ZXT375U175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474606920), received between Feb 10, 2017 and Jan 7, 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. How this data works · Data updated Oct 13, 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.

• InjuryJan 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT375 INTRAOCULAR LENS (IOL)WAS IMPLANTED IN THE PATIENT'S LEFT (OS) OPERATIVE EYE ON (B)(6) 2019. PATIENT COMPLAINED THAT SHE COULD NOT SEE FOOD ON HER PLATE, COULD NOT READ, AND COULD NOT SEE THINGS IN HER KITCHEN CABINETS WITHOUT READERS. SHE CANNOT CLEAN HER COUNTER TOPS, OR READ A NEWSPAPER. SHE REPORTED THAT LENS FRAGMENTS WERE LEFT IN HER EYE SO VITRECTOMY WAS PERFORMED. ASTIGMATISM WAS CORRECTED; HOWEVER, SHE HAS HALOS AND BLURRY VISION. THE SURGEON WOULD LIKE TO DO LASIK OR A PHOTOREFRACTIVE KERATECTOMY (PRK) AT THE NEXT FOLLOW UP VISIT. SHE DOES NOT WANT TO DRIVE AT NIGHT. WHEN SHE WOULD COVER HER LEFT EYE EVERYTHING WAS BLURRY, WHEN SHE COVERED HER RIGHT EYE EVERYTHING WAS PERFECT. LEFT EYE IS WORKING 20/20, AND THE SURGEON TOLD HER THAT HER RIGHT EYE IS 20/20 AS WELL. SHE WAS INFORMED THAT SHE HAD DIABETIC RETINOPATHY ABOUT TWO WEEKS AFTER HER SURGERY, DURING SECOND POST-OP VISIT. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT REPRESENTS THE LEFT EYE. A SEPARATE REPORT WILL BE FILED FOR THE RIGHT EYE.

  Patient problems: Blurred Vision; Halo; Vitrectomy

  MAUDE report 9560792 ↗
• InjuryApr 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S FIRST MULTIFOCAL TORIC IOL IMPLANTED IN THE RIGHT EYE (OD) WAS PERFECT. PRE-OP -4.50+4.50X95, AND POST-OP -0.25+0.25X95. THE SECOND EYE, LEFT EYE (OS) WAS -6.00+2.50X105 PRE-OP AND +0.50+0.75X180. THE PATIENT WAS REPORTED TO BE HYPEROPIC WITH CYLINDER IN FLIPPED AXIS. REPORTEDLY, THE MODEL ZXT375 LENS WAS USED, WITH AN EXPECTATION OF RESIDUAL AT 92 DEGREES. THE LENS WAS EXPLANTED ON (B)(6) 2018 AND REPLACED WITH A DIFFERENT MODEL IOL, ZXT300 (16.0 DIOPTER). IT IS UNKNOWN EXACTLY WHEN THE VISUAL ISSUES FIRST STARTED. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES WERE REQUIRED AT EXPLANT/EXCHANGE. THERE WAS NO PATIENT POST-OP INJURY AND NO COMPLICATIONS REPORTED. IT WAS CONFIRMED THAT THE PATIENT WAS WELL POST-OP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7437508 ↗
• InjuryJan 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT375 17.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017, DUE TO UNEXPECTED POST-OPERATIVE REFRACTION RESULTS OF +1.00 X -1.00 X 180. PATIENT REPORTED AT POST OP WEEK ONE, VISUAL ACUITY FOR DISTANCE VISION WAS WELL; BUT HAD HARD TIME WITH SMALL PRINT. REPORTED GLARE AND HALOS, VISION IS SMUDGY, AND FEELS DRY AT TIMES, WITH ASTIGMATISM NOTED AT THE THREE WEEK FOLLOW UP. THE REPLACEMENT LENS WAS A MONOFOCAL, MODEL ZCB00 22.0 DIOPTER LENS. AT POST OP DAY ONE VISION ACUITY IS BETTER WHILE READING, 20/25. AT POST OP WEEK ONE, VISUAL ACUITY IMPROVING, CLEARING UP AND 20/20 NEAR AND 20/25+2 FOR DISTANCE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 7229529 ↗
• InjuryNov 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS SYMFONY TORIC LENS (MODEL # ZXT375 17.5 DIOPTER) WAS IMPLANTED ON (B)(6) 2017 IN THE LEFT EYE OF A (B)(6) FEMALE PATIENT. REPORTEDLY, THE LENS WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE ON (B)(6) 2017 BECAUSE OF UNEXPECTED POST-OP REFRACTION. NO INCISION ENLARGEMENT WAS REPORTED. ANOTHER TORIC LENS (MODEL# ZCT450) WAS IMPLANTED WITH THE SAME 17.5 DIOPTER. THE PATIENT WAS REPORTED AS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7054707 ↗
• InjuryFeb 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT375 17.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A MALE PATIENT'S LEFT EYE DUE TO THE PATIENT NOT BEING ABLE TO TOLERATE THE SYMFONY LENS. THE LENS WAS REPLACED WITH A PCB00 18.0 DIOPTER IOL. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES REQUIRED. FURTHERMORE, THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Code Available

  MAUDE report 6321197 ↗