TECNIS IOL ZCT300 (REF ZCT300U180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474553286), received between Sep 13, 2016 and Apr 5, 2018 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unintended Movement” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A TECNIS TORIC INTRAOCULAR LENS (IOL) WAS PLACED AT 008 DEGREES IN THE PATIENT¿S RIGHT EYE DURING SURGERY ON (B)(6) 2017. THE PLACEMENT WAS MEASURED AT THE 6-MONTH VISIT ON (B)(6) 2017 AND WAS FOUND TO BE AT 178 DEGREES. IT WAS NOTED THAT THE IMPLANT PROCEDURE WAS COMPLETED SUCCESSFULLY. THE LENS REMAINS IMPLANTED. THE PATIENT IS DOING WELL AND THE OUTCOME IS NOT INTERFERING WITH DAILY ACTIVITIES. THERE WAS NO PATIENT COMPLICATION AND/OR RELATED INJURY AND THERE ARE NO IOL REPOSITIONING IS PLANNED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7399910 ↗
• InjuryFeb 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT300 18.0 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 BECAUSE THE PATIENT WAS UNHAPPY WITH THE POST-OPERATIVE RESULTS. THE PATIENT ALSO COMPLAINT OF BLURRY VISION. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS A ZCT150 15.0 DIOPTER LENS. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING GOOD POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7268262 ↗
• InjurySep 13, 2016Unintended Movement; Device Handling Problem; Unintended Movement; Device Handling Problem

  IT WAS REPORTED ON THAT ON (B)(6) 2016, THE SURGEON IMPLANTED A ZCT300 INTRAOCULAR LENS (IOL) IN THE LEFT (OS) EYE OF A FEMALE PATIENT ON THE WRONG AXIS (OF 168 DEGREES) AND REALIZED HIS MISTAKE POSTOPERATIVELY. INTENDED AXIS FROM AMO TORIC CALCULATOR WAS 92 DEGREES. THE PATIENT REQUIRED A SECONDARY SURGICAL INTERVENTION TO REPOSITION THE LENS. THE PATIENT REPORTED THAT HER VISION WAS A LITTLE BLURRY ONE (1) DAY POSTOPERATIVELY. IT WAS REPORTED THAT NO OTHER COMPLICATION IS REPORTED BY THE PATIENT TO DATE. THE (UCVA) UNCORRECTED VISUAL ACUITY (SNELLEN CHART) WAS 20/100 ONE (1) DAY POSTOPERATIVELY. ON (B)(6) 2016 (10 DAYS POST OP), THE PATIENT RETURNED FOR A VISIT TO MEASURE THE LENS AXIS PRIOR TO THE REPOSITIONING SURGERY. THE PATIENT AXIS WAS MEASURED AND IT REVEALED A 12 DEGREES ROTATION (FROM 168 TO 180). HENCE, LENS REPOSITIONING WAS SCHEDULED AND IT OCCURRED ON (B)(6) 2016 AND PATIENT WAS FINE/DOING WELL POST-OPERATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 5947057 ↗