TECNIS IOL ZCT150 (REF ZCT150U185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474552111), received between Sep 7, 2016 and Jul 12, 2024 — classified as 7 injuries, 1 malfunction.

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

• InjuryJul 12, 2024Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE DUE TO DISLOCATION AND MIGRATION OF THE LENS. THE LENS WAS REPLACED WITH A NON JNJ LENS IN A SECONDARY PROCEDURE. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PATIENT IS GOOD. IMTEC30 WAS USED AS INJECTOR. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19733895 ↗
• InjuryJan 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ZCT150 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). THE IOL WAS EXPLANTED DURING A SECONDARY SURGICAL PROCEDURE DUE TO UNKNOWN REASONS; INFORMATION REGARDING THE REPLACEMENT IOL IS ALSO UNKNOWN. THERE WAS NO PATIENT INJURY. PATIENT OUTCOME POST-LENS EXCHANGE IS UNKNOWN. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 18567746 ↗
• MalfunctionSep 19, 2019Contamination; Contamination

  IT WAS REPORTED THAT A ZCT150 INTRAOCULAR LENS (IOL) MIGHT BE REMOVED FROM THE PATIENT¿S EYE DUE TO SMUDGES FROM TECH GLOVES ON THE IOL. FOLLOW-UP CONFIRMED THAT THE CUSTOMER IS ACTUALLY NOT SURE WHERE THE SMUDGE CAME FROM. THE LENS REMAINS IMPLANTED AND THERE ARE NO PATIENT VISUAL ISSUES. THAT THE PLAN FOR NOW IS TO LEAVE THE LENS IN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9085255 ↗
• InjuryApr 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL), MODEL ZCT150, 18.5 DIOPTER, WAS EXPLANTED FROM THE LEFT EYE (OS) AS THE PATIENT WAS UNABLE TO FOCUS AND DRIVE AT NIGHT AND DUE TO UNEXPECTED POSTOP REFRACTION. REPORTEDLY, THE OUTCOME SIGNIFICANTLY INTERFERED WITH THE PATIENT'S DAILY LIFE ACTIVITIES. A REPLACEMENT LENS OF THE SAME MODEL, BUT DIFFERENT DIOPTER (19.5) WAS USED. THERE WAS NO INCISION ENLARGEMENT REQUIRED. IT WAS INDICATED THAT THE PATIENT HAS RECOVERED AND NO PATIENT INJURY WAS REPORTED. THE EXPLANTED LENS WAS DISCARDED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8512904 ↗
• InjuryDec 17, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZCT150 18.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT COMPLAINED OF POOR VISUAL ACUITY. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 20.0. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available; Visual Impairment

  MAUDE report 8172117 ↗
• InjuryAug 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT150 18.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. POST-OPERATIVELY ON (B)(6) 2018, THE PATIENT COMPLAINED OF SEEING RINGS AND HALOS IN THE RIGHT EYE AT NIGHT WHEN LOOKING AT ONCOMING TRAFFIC. ALSO, THE DISTANCE VISION CORRECTED WAS 20/20, THE NEAR SIGHTED VISION CORRECTED WAS J1+, AND THE AUTO REFRACTION WAS -0.75 X +0.50 X 137. POST-OPERATIVELY ON (B)(6) 2018, THE PATIENT COMPLAINED OF BLURRY VISION IN THE RIGHT EYE, BELIEVES HE HAS A FOREIGN BODY IN THE RIGHT EYE FROM YARD WORK, AND VITREOUS FLOATERS IN BOTH EYES. ALSO, THE DISTANCE VISION CORRECTED WAS 20/20 AND THE AUTO REFRACTION WAS -0.25 X +0.75 X 152. IT WAS LATER EXPLANTED ON (B)(6) 2018. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 7828610 ↗
• InjuryFeb 2, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A ZCT150 18.5 DIOPTER INTRAOCULAR LENS WAS INSERTED IN A MALE PATIENT'S RIGHT EYE, BUT HAD TO BE REMOVED DUE TO THE PATIENT'S CAPSULE RUPTURING. FURTHER CLARIFICATION WAS PROVIDED THAT HOW THE EVENT OCCURRED WAS THAT THE LENS UNFOLDED, WAS IMPLANTED BUT THE CAPSULE TORE. THE PHYSICIAN IS NOT SURE BUT STATED THAT THE LENS HAD A JAGGED EDGE, DESCRIBED AS A PIECE OF PLASTIC OR SOMETHING ON THE LENS THAT CAUSED THE CAPSULE TO TEAR/RUPTURE. THE LENS WAS REMOVED FROM THE EYE AND A VITRECTOMY WAS REQUIRED. THE REPLACEMENT LENS WAS A NON-AMO DEVICE. THERE WAS NO INCISION ENLARGEMENT AND NO PATIENT POST-OP INJURY.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 6295401 ↗
• InjurySep 7, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO A POOR POST-OP REFRACTION. THERE WAS NO INCISION ENLARGEMENT OR PATIENT CONSEQUENCE. THE REPLACEMENT LENS WAS UNKNOWN.

  Patient problems: No Code Available

  MAUDE report 5931569 ↗