TECNIS IOL ZCT300 (REF ZCT300U235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474553392), received between Jan 23, 2017 and Oct 31, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (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.

• InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ZCT300 INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL LENS DUE TO COMPLAINTS OF GLARE AND BRIGHT LINES; PATIENT NOT HAPPY WITH SEEING LINES IN VISION. THERE WAS NO PATIENT INJURY AND PATIENT OUTCOME POST-LENS EXCHANGE WAS REPORTED AS OK. THE ZCT300 IS NOT AVAILABLE FOR RETURN. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION RECEIVED INDICATED THERE WERE NO COMPLICATIONS SUCH AS CAPSULE TEAR, NO INCISION ENLARGEMENT, NO UNPLANNED SUTURE(S), AND NO UNPLANNED VITRECTOMY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 15697753 ↗
• InjuryJul 31, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IT HAS BEEN OVER ONE (1) YEAR THAT THE PATIENT HAS BEEN HAVING ISSUES WITH BOTH EYES. IT WAS REPORTED THAT A MALE PATIENT HAS BEEN SUFFERING FOR OVER ONE (1) YEAR. WITH ONE EYE HE CAN SEE VERY CLOSE AND WITH THE OTHER EYE HE CAN ONLY SEE FAR AWAY AND THAT HE CANNOT READ WITH EITHER EYES. IT WAS REPORTED THAT THE PATIENT IS UNBALANCED WHEN HE LOOKS THROUGH BOTH EYES. THE PATIENT VISITED HIS DOCTOR AND WAS GIVEN PRESCRIPTION GLASSES WHICH HAS NOT HELP HIM AT ALL. THE PATIENT HAS DIFFICULTY DRIVING AND GETS DIZZY AS THERE IS NO BALANCE. THE PATIENT SAW ANOTHER DOCTOR WHO CONFIRMED THE FIRST DOCTOR¿S DIAGNOSIS, THAT HE WOULD NEED GLASSES. BOTH DOCTORS INFORMED THE PATIENT THAT THERE IS NO PLAN TO EXPLANT THE LENSES. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT PERTAINS TO PATIENT'S RIGHT EYE (OD). A SEPARATE REPORT WILL BE SUBMITTED FOR THE PATIENT'S LEFT EYE (OS).

  Patient problems: Dizziness; Visual Disturbances

  MAUDE report 6753225 ↗
• MalfunctionJun 13, 2017Scratched Material; Scratched Material

  IT WAS REPORTED THAT THERE WAS A SCRATCH ON THE INTRAOCULAR LENS (IOL). THERE WAS PATIENT CONTACT. THE ISSUE WAS NOTICED DURING INSERTION OF THE IOL INTO THE EYE. THE IOL WAS REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6639099 ↗
• MalfunctionJan 23, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A TECNIS TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE OF A (B)(6) FEMALE PATIENT. THE IOL, INITIALLY PLACED AT 95 DEGREES, WAS MEASURED AT SIX-MONTH VISIT AT 78 DEGREES, WITH A DIFFERENCE OF 17 DEGREES. REPORTEDLY, THE PATIENT HAD NO COMPLAINTS AT THE SIX-MONTH VISIT. THE LENS REMAINED IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6270790 ↗