TECNIS IOL ZCT300 (REF ZCT300U195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474553316), received between Mar 24, 2017 and Jul 31, 2019 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2019Failure to Eject; Failure to Eject

  IT WAS REPORTED ZCT300 19.5 DIOPTER INTRAOCULAR LENS (IOL) WAS STUCK IN THE CARTRIDGE AND WOULD NOT ADVANCE OR REMOVE. IT WAS ALSO REPORTED THERE WAS AN INCISION ENLARGEMENT REQUIRED AND ANOTHER CARTRIDGE WAS USED TO INSERT THE BACK-UP LENS. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 8848952 ↗
• InjuryJan 29, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT300 19.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT FELT OFF BALANCE/DIZZY POST-OPERATIVELY. IT WAS ALSO REPORTED THAT THE LENS ROTATED, BUT THE DEGREE OF ROTATION POST-OPERATIVELY IS UNKNOWN. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER (19.0). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dizziness; No Code Available

  MAUDE report 8284025 ↗
• MalfunctionNov 27, 2018Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF A ZCT300 19.5 DIOPTER INTRAOCULAR LENS (IOL) WAS BROKEN INSIDE THE CARTRIDGE. THERE WAS PATIENT CONTACT REPORTED BUT NO PATIENT INJURY AND NO SURGICAL INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER LENS, SAME MODEL AND DIOPTER SIZE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8109385 ↗
• InjuryDec 26, 2017Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A ZCT300 19.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 BECAUSE THE PATIENT GOT A ZCT MODEL INADVERTENTLY INSTEAD OF A ZXT MODEL. THE DOCTOR FOUND THE ERROR WHEN HE WAS REVIEWING THE LABELS THE DAY AFTER THE SURGERY, (B)(6) 2017. THERE WAS NO INCISION ENLARGEMENT PERFORMED AND THERE WAS NO PATIENT INJURY. REPORTEDLY, WHEN THE DOCTOR'S OFFICE CONTACTED THE PATIENT, SHE STATED THAT HER NEAR VISION WAS NOT AS GOOD AS THE OTHER EYE. THE PATIENT HAD NO ISSUES POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 7146956 ↗
• InjurySep 25, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A ZCT300 19.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2017, IN THE LEFT EYE (OS). IT WAS LATER EXPLANTED ON (B)(6) 2017, DUE TO THE LENS FLIPPED OUT OF ITS AXIS, WHICH RESULTED IN A PATIENT COMPLAINT OF BLURRED VISION. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED. THE REPLACEMENT LENS WAS A MODEL, ZCT400 WITH A DIFFERENT, 18.5 DIOPTER. REPORTEDLY, THE PATIENT IS FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 6892489 ↗
• MalfunctionMar 24, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT LATHE MARKS WERE OBSERVED ON THE OPTIC OF AN INTRAOCULAR LENS (IOL). REPORTEDLY, THE LENS WAS IMPLANTED IN THE PATIENT'S EYE AND REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6433562 ↗