TECNIS IOL ZCT150 (REF ZCT150U250)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474552241), received between Jan 5, 2017 and Oct 29, 2020 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2020Break; Break

  THIS REPORT SUMMARIZES <NOE> 2 </NOE> MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO LENS DAMAGE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10753237 ↗
• MalfunctionApr 24, 2020Break; Break

  THIS REPORT SUMMARIZES <NOE> 2 </NOE> MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO LENS DAMAGE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9998758 ↗
• MalfunctionJan 30, 2020Break; Break

  THIS REPORT SUMMARIZES <NOE> 4 </NOE> MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO LENS DAMAGE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9647984 ↗
• MalfunctionOct 29, 2019Break; Break

  THIS REPORT SUMMARIZES <NOE> 4 </NOE> MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO LENS DAMAGE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9251440 ↗
• InjuryFeb 25, 2019Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A TEAR WAS SEEN IN THE POSTERIOR CHAMBER DURING POSITIONING OF THE TECNIS TORIC INTRAOCULAR LENS (MODEL ZCT150) IN PATIENT¿S OPERATIVE EYE. LENS COULD NOT BE CENTERED PROPERLY. THE LENS WAS REMOVED AND REPLACED WITH MODEL AR40. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 8368932 ↗
• InjuryJun 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS TORIC INTRAOCULAR LENS (MODEL ZCT150, +25.0 DIOPTER) WAS REMOVED DUE TO CAPSULAR TEAR/ VITRECTOMY. THERE WAS NO PATIENT INJURY AND THE LENS WAS NOT IMPLANTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 7599825 ↗
• InjuryNov 17, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A ZCT150 25.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 BECAUSE THE DOCTOR REPORTED THAT THERE WAS A SUBSTANCE ON THE BACK OF THE IMPLANTED LENS CAUSING THE PATIENT GLARE. THERE WAS AN INCISION ENLARGEMENT PERFORMED, BUT NO VITRECTOMY OR SUTURES WERE USED. THE LENS WAS REPLACED WITH ANOTHER ZCT MODEL, BUT DIFFERENT DIOPTER OF 25.5. REPORTEDLY, THERE WAS NO PATIENT INJURY OR POST-OPERATIVE PATIENT COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7043675 ↗
• InjuryJan 5, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT150 INTRAOCULAR LENS WAS EXPLANTED FROM A FEMALE PATIENT'S LEFT EYE. PHYSICIAN NOTED THAT THERE WERE NO COMPLICATIONS DURING THE ORIGINAL SURGERY. ORIGINAL INTENDED AXIS OF THE LENS WAS 86 DEGREES; HOWEVER POST IMPLANT THE IOL IS IN THE EYE AT 76 DEGREES, ALSO NOTED WAS MYOPIC REFRACTIVE SURPRISE. SYMPTOMS WERE RESIDUAL MYOPIC ASTIGMATISM WITH ANISOMETROPIA. THE RESPONSE TO OUTCOME SIGNIFICANTLY INTERFERES WITH ACTIVITIES OF DAILY LIFE WAS YES. POST EXPLANT / CURRENT STATUS INDICATES THE PATIENT HAS RECOVERED.

  Patient problems: No Code Available

  MAUDE report 6224390 ↗