TECNIS IOL ZCT300 (REF ZCT300U110)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474553149), received between Mar 23, 2017 and Apr 5, 2022 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD AN ISSUE. ADDITIONAL INFORMATION RECEIVED REVEALED THAT THE LEADING HAPTIC OF THE INTRAOCULAR LENS (IOL) WAS CAUGHT BETWEEN THE PISTON AND OPTIC UPON ATTEMPTED INSERTION AND THE HAPTIC GOT PULLED OFF. THERE WAS CONTACT WITH PATIENT'S OPERATIVE EYE. ANOTHER LENS OF DIFFERENT MODEL (A 3-PIECE LENS) WAS PLACED IN THE SULCUS. NO OTHER INTERVENTION WAS REQUIRED. THE ORIGINAL LENS WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14017726 ↗
• MalfunctionApr 5, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD AN ISSUE. ADDITIONAL INFORMATION RECEIVED REVEALED THAT THE TRAILING HAPTIC OF THE INTRAOCULAR LENS (IOL) WAS PINCHED IN THE NOSECONE UPON ATTEMPTED INSERTION AND THE HAPTIC GOT BENT AND FRACTURED. THERE WAS CONTACT WITH PATIENT'S EYE. ANOTHER LENS OF DIFFERENT MODEL (A 3-PIECE LENS) WAS PLACED IN THE SULCUS. NO OTHER INTERVENTION WAS REQUIRED. THE ORIGINAL LENS WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14017670 ↗
• MalfunctionJul 10, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A ZCT300 11.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. THE LENS PLACED AT 14 DEGREES, WAS MEASURED AT 160 DEGREES AT THE PATIENT'S 6-MONTH FOLLOW UP VISIT ON (B)(6) 2018. THERE WERE NO PATIENT COMPLICATIONS AND/OR RELATED INJURY AND THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. REPORTEDLY, THE LENS REMAINS IMPLANTED AND NO IOL REPOSITIONING WAS PERFORMED OR PLANNED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7673174 ↗
• MalfunctionMar 23, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THERE WAS A MISALIGNMENT OF 11 DEGREES BETWEEN OPERATIVE AND THE 4 MONTH POSTOPERATIVE VISIT. THE INTRAOCULAR LENS (IOL) WAS PLACED AT 76 DEGREES IN THE RIGHT EYE DURING THE INITIAL SURGERY ((B)(6) 2016) AND WAS MEASURED AT THE 4 MONTH VISIT (16 FEB 2017) TO BE AT 65 DEGREES, WITH A DIFFERENCE OF 11 DEGREES. THE PATIENT COMPLAINED OF FLASHES OF LIGHT AND HAZINESS IN THE RIGHT EYE. NO OTHER PATIENT COMPLICATIONS AND/OR RELATED INJURIES. THE IOL REMAINS IMPLANTED. NO REPOSITIONING WAS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: Flashers; Visual Disturbances

  MAUDE report 6426842 ↗