TECNIS IOL ZCT150 (REF ZCT150U205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474552159), received between Aug 14, 2017 and Jan 6, 2020 — classified as 6 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. How this data works · Data updated Oct 13, 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.

• InjuryJan 6, 2020Break; Unintended Movement; Break; Unintended Movement

  IT WAS REPORTED THAT DURING A POST-OP EXAM, THE INTRAOCULAR LENS (IOL) HAD ROTATED GREATER THAN OR EQUAL TO 10 DEGREES. ASTIGMATISM INCREASED AFTER CATARACT SURGERY. LENS WAS EXPLANTED. PATIENT STATUS IS UNKNOWN. THE EXPLANTED IOL WAS REPLACED WITH ANOTHER IOL OF THE SAME MODEL BUT DIFFERENT DIOPTER. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9553187 ↗
• InjuryNov 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING POSITIVE DYSPHOTOPSIA. THROUGH FOLLOW UP, IT WAS LEARNED THAT 1-DAY POST-OPERATIVE (OP), THE PATIENT COMPLAINED OF FLUTTERING IN PERIPHERAL VISION. 2 WEEKS POST-OP, THE PATIENT COMPLAINED OF SEEING FLASHING LIGHT. UNAIDED VISUAL ACUITY WAS 20/25. THE PATIENT WAS SENT FOR A SECOND OPINION AND DECIDED TO PROCEED WITH AN IOL EXCHANGE. THE IOL WAS EXPLANTED AND AN INCISION ENLARGEMENT WAS REQUIRED, HOWEVER, THERE WERE NO OTHER COMPLICATIONS. THE SURGERY WAS COMPLETED USING A NON-JOHNSON & JOHNSON REPLACEMENT LENS. THE PATIENT WAS GIVEN ADVIL TO RELIEVE PAIN POST-OP. UNAIDED VISUAL ACUITY WAS 20/200. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 9383839 ↗
• InjuryAug 30, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT PATIENT WAS SCHEDULED FOR LENS EXCHANGE (B)(6) 2019. LENS IMPLANT IN PATIENT¿S RIGHT EYE. INTRAOCULAR LENS MASTER RECOMMENDED AN 18.50, ORA (OCULAR RESPONSE ANALYZER) SUGGESTED 20.50. LENS MODEL ZCT150 +20.5 DIOPTER WAS INITIALLY IMPLANTED RESULTING IN A +1.25 -.75 X 127 REFRACTION POST OPERATIVELY. LENS POSITION WAS AT 165 DEGREES. THE PATIENT HAD 2+ POSTERIOR CHAMBER OPACIFICATION (PCO). PATIENT NOTED TO HAVE LONG EYES. (B)(6) 2019, PATIENT'S RIGHT EYE, UCVA (UNCORRECTED VISUAL ACUITY) 20/50+ AND BCVA (BEST CORRECTED VISUAL ACUITY) 20/20 . ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT LENS WAS EXPLANTED IN SECONDARY SURGICAL PROCEDURE DUE TO ANISOMETROPIA. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES, NO VITRECTOMY REQUIRED. PATIENT WAS DOING WELL. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8952770 ↗
• InjuryJul 12, 2019Adverse 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 FROM THE PATIENT'S RIGHT EYE DUE TO PATIENT EXPERIENCING A SHADOW IMAGE. REPORTEDLY, DOCTOR USED ORA (OCULAR RESPONSE ANALYZER). THE LENS AND SPHERICAL POWER WERE INCORRECT/OFF ALONG WITH THE IOL AXIS. PATIENT SYMPTOMS RESOLVED POST OP DAY ONE FOLLOWING THE LENS EXCHANGE. NO FURTHER INFORMATION WAS PROVIDED. PRE-OPERATIVE: 20/40 FOLLOWING INITIAL IMPLANT. POST-OP: 20/20 FOLLOWING LENS EXCHANGE.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8787244 ↗
• InjuryMay 13, 2019Adverse 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 DUE TO PATIENT NEEDING A DIFFERENT POWER LENS. PRODUCT NOTED TO BE NOT RETURNING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8605759 ↗
• InjuryAug 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE, FROM THE LEFT EYE OF A FEMALE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE LENS WAS EXPLANTED BECAUSE OF A REFRACTIVE SURPRISE. NO INCISION ENLARGEMENT, NO VITRECTOMY WAS PERFORMED, NO SUTURES WERE USED AND NO PATIENT POST-OP INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 6793481 ↗