TECNIS IOL ZCT600 (REF ZCT600U170)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474604100), received between Nov 15, 2016 and Aug 20, 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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 20, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT'S RIGHT EYE (OD) WAS IMPLANTED WITH A MODEL ZCT600 TORIC IOL (INTRAOCULAR LENS). THE LENS WAS FOUND MISALIGNED BY 20 DEGREES AT THE PATIENT'S 6 MONTH POST OP VISIT. THE ORIGINAL PLACEMENT WAS AT 112 DEGREES, AT THE 6-MONTH VISIT THE LENS AXIS WAS AT 92* DEGREES. DESPITE THE UNINTENDED MOVEMENT, PATIENT OUTCOME DID NOT IDENTIFY ANY SIGNIFICANT INTERFERENCE WITH ACTIVITIES OF DAILY LIFE. THERE WAS NO PATIENT COMPLICATION, RELATED INJURY, NO PATIENT COMPLAINTS AND THERE WILL BE NO SECONDARY SURGICAL PROCEDURE PERFORMED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7799262 ↗
• InjuryJan 30, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT600 17.0 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 FELT AS THOUGH THE LENS HAD MOVED AND BECAUSE THE PATIENT EXPERIENCED BLURRY AND DOUBLE VISION AT DISTANCE. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED. THE REPLACEMENT LENS WAS A NON-AMO LENS. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 7230024 ↗
• InjuryNov 15, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT600 INTRAOCULAR LENS (IOL) WAS EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6105048 ↗