TECNIS IOL ZCT300 (REF ZCT300U260)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474553446), received between Jun 12, 2018 and Oct 4, 2018 — classified as 3 injuries.

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.

• InjuryOct 4, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT MODEL ZCT300 TECNIS TORIC IOL (INTRAOCULAR LENS) WAS PLACED AT 98 DEGREES IN THE PATIENT'S RIGHT EYE (OD). AT 1-MONTH STUDY VISIT, (B)(6) 2018, IOL WAS MEASURED AT 115 DEGREES. THIS OUTCOME DID NOT AFFECT PATIENT'S DAILY ACTIVITIES AND THERE WAS NO PATIENT INJURY. THERE IS NO PLANNED OR PERFORMED TREATMENT AT THIS TIME. THE LENS REMAINS IMPLANTED. THE PATIENT REPORTED BLURRED AND HAZY VISION WHEN NOT WEARING GLASSES OR CONTACTS. MILD PHYSICAL DISCOMFORT RELATED TO EYE WAS ALSO NOTED IN 1-MONTH STUDY VISIT. THE PATIENT HAD MILD BLURRED, HAZY VISION AND MILD PHYSICAL DISCOMFORT RELATED TO VISION, WHICH CONTINUED TO PERSIST. THERE WERE NO OTHER MEDICAL FINDINGS NOTED AT THIS VISIT. THE PATIENT CONCLUDED HIS 6-MONTH STUDY VISIT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; Discomfort; Halo

  MAUDE report 7937058 ↗
• InjuryJul 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TECNIS TORIC INTRAOCULAR LENS (MODEL ZCT300, +26.0 DIOPTER) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE BECAUSE OF ANISOMETROPIA. THERE WAS NO PATIENT INJURY, NO MEDICAL OR SURGICAL INTERVENTION AND NO INCISION ENLARGEMENT PERFORMED. REPORTEDLY, LENS MODEL ZCT450 +26.0 DIOPTER WAS IMPLANTED AS A REPLACEMENT. THE PATIENT WAS REPORTED DOING GOOD WHEN DISCHARGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7717577 ↗
• InjuryJun 12, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT300 26.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018 AT AN AXIS OF 002 DEGREES. POST-OPERATIVELY ON (B)(6) 2018, AT THE PATIENT'S FOLLOW UP VISIT, THE PATIENT HAD BLURRED VISION SECONDARY TO A SHIFT IN THE CORNEA WHICH CREATED A SHIFT IN THE AXIS OF CYLINDER CAUSING THE LENS AXIS TO CHANGE TO 010 DEGREES. THEREFORE, A LENS REPOSITIONING PROCEDURE WAS PERFORMED ON (B)(6) 2018. REPORTEDLY, THERE WAS NO PATIENT COMPLICATIONS AND/OR RELATED INJURY. OUTCOMES DID NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7594300 ↗