TECNIS IOL ZCT300 (REF ZCT300U250)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474553422), received between Feb 13, 2018 and Aug 30, 2019 — classified as 3 injuries, 3 malfunctions.

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

• InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT A ZCT300 INTRAOCULAR LENS WAS IMPLANTED IN THE RIGHT EYE. THE PATIENT REPORTED GHOSTING AND BLURRED VISION IN THE RIGHT EYE. THE PATIENTS VISION WAS CRISP FOR APPROXIMATELY 1 1/2 DAYS FOLLOWING SURGERY AT WHICH TIME THE VISION BECAME BLURRY. THE LENS WAS CHECKED FOR POSSIBLE ROTATION BUT IT WAS DETERMINED THAT THE IOL HAD NOT ROTATED AND THAT IT WAS PLACED AS PER MANIFEST CALCULATIONS. ADDITIONAL INFORMATION RECEIVED REVEALED THERE IS NO PLANNED INTERVENTION AT THIS TIME. THE PATIENTS SYMPTOMS AFFECT HER ABILITY TO PERFORM DAILY ACTIVITIES. NO ADDITIONAL INFORMATION WAS PERFORMED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 8949853 ↗
• MalfunctionJul 30, 2019Break; Break

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO LENS DAMAGED. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8844302 ↗
• MalfunctionJul 30, 2019Break; Break

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO LENS DAMAGED. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8844255 ↗
• MalfunctionOct 1, 2018Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT DURING IMPLANT OF THE INTRAOCULAR LENS (IOL), THE LENS DID NOT UNFOLD AND WAS STUCK IN DELIVERY DEVICE. REPORTEDLY, THERE WAS NO PATIENT INJURY AND NO SUTURES USED. THE LENS WAS REPLACED WITH THE SAME MODEL AND SIZE LENS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7924635 ↗
• InjuryJul 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT300 25.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE OF RESIDUAL MYOPIA. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS A NON-JOHNSON AND JOHNSON LENS. REPORTEDLY, THE PATIENT IS DOING GOOD POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7733850 ↗
• InjuryFeb 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT300 25.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. IT WAS LATER EXPLANTED BECAUSE THE PATIENT WAS UNHAPPY WITH THEIR POST-OPERATIVE OUTCOME. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7268372 ↗