TECNIS IOL ZCT150 (REF ZCT150U180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05050474552104), received between Nov 7, 2016 and Jun 11, 2020 — classified as 6 injuries, 4 malfunctions.

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING THE CATARACT SURGERY, A TORIC INTRAOCULAR LENS WAS PLACED IN PATIENT¿S RIGHT EYE AT 45 DEGREES ON (B)(6) 2019. THE TORIC LENS WAS LATER REPOSITIONED TO 30 DEGREES ON (B)(6) 2020 DUE TO PATIENT EXPERIENCING ROTATION. REPORTEDLY THE LENS WILL BE EXPLANTED FROM PATIENT¿S RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE ON (B)(6) 2020 AS SURGEON REPORTED THAT PATIENT IS EXPERIENCING RESIDUAL MONOCULAR DIPLOPIA, POOR UNCORRECTED DISTANCE VISION WITH MONOVISION, AND HAS A HISTORY OF MYOPIC LASIK IN 1999. THE PATIENT NEEDS A HIGHER TORIC CORRECTION. THE EXPLANT IS NOT CONFIRMED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 10146819 ↗
• MalfunctionApr 30, 2019Break; Break

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS. THE EVENT WAS RELATED TO LENS DAMAGE. THERE WAS NO PATIENT INJURY REPORTED ASSOCIATED TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8563546 ↗
• MalfunctionJul 3, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD MULTIPLE FIBERS/HAIR ON IT. PER CUSTOMER IT WAS NOTICED WHILE LOADING THE LENS. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7658064 ↗
• InjuryMay 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT150 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S EYE. THE REASON FOR EXPLANT IS UNKNOWN. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7535993 ↗
• InjuryMar 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT150 18.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT COULD NOT SEE WELL POST-OPERATIVELY. THE REPLACEMENT LENS WAS A ZCB00 21.5 DIOPTER LENS. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 7376172 ↗
• InjuryJan 4, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZCT150 18.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017, BECAUSE OF A LENS MISCALCULATION. THERE WAS NO INCISION ENLARGEMENT OR VITRECTOMY PERFORMED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT, SMALLER DIOPTER OF 15.0. REPORTEDLY, THE OUTCOME SIGNIFICANTLY INTERFERED WITH THE PATIENT'S ACTIVITIES OF DAILY LIFE. THE PATIENT HAS NOW RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7166665 ↗
• MalfunctionMar 27, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD LATHE MARKS ON THE OPTIC AREA. THE EVENT WAS NOTICED DURING HANDLING BUT PRIOR TO INSERTION. NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Patient Involvement

  MAUDE report 6437900 ↗
• MalfunctionMar 21, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT LATHE MARKS WERE OBSERVED ON AN INTRAOCULAR LENS (IOL) DURING IMPLANTATION. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THERE WAS NO PATIENT INJURY AND NO VITRECTOMY WAS PERFORMED. THE PATIENT WAS REPORTED DOING FINE AND HER VISION WAS 20/20 DURING HER POST-OP EXAMINATION ON (B)(6) 2017. REPORTEDLY THE LENS REMAINED IMPLANTED. THE PATIENT WAS ASYMPTOMATIC AND DID NOT COMPLAIN ABOUT LATHE LINES OR ANY OTHER ISSUES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6423410 ↗
• InjuryJan 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED AS THE PATIENT COMPLAINED OF SEEING A ''FOLD''. THE PATIENT WAS REPORTED AS FINE FOLLOWING EXPLANT. THERE WAS NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6265711 ↗
• InjuryNov 7, 2016Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT150 18.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO DISPLACEMENT OF LENS. THROUGH FOLLOW UP WITH THE CUSTOMER IT WAS LEARNED THAT THE LENS DROPPED BACK IN THE EYE AS THE CAPSULE BURST. THE CUSTOMER COULD NOT CONFIRM IF THE CAPSULE WAS WEAK, HOWEVER THE CAPSULE BROKE AS IT DID NOT HOLD THE LENS. A VITRECTOMY WAS REQUIRED, BUT THERE WAS NO INCISION ENLARGEMENT. THE LENS WAS REPLACED WITH A NON-AMO ANTERIOR CHAMBER LENS.

  Patient problems: Capsular Bag Tear; No Code Available; Vitrectomy

  MAUDE report 6081630 ↗