TECNIS IOL ZCT150 (REF ZCT150U160)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474552067), received between Aug 17, 2017 and Oct 13, 2020 — classified as 5 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED REPORT THAT THE PATIENT IS NOT HAPPY WITH THEIR NEAR VISION. PATIENT HAS HISTORY OF MONOVISION BUT DECIDED TO USE A SYMFONY IN BOTH EYES TO HELP WITH THE NEAR VISION. PATIENT IS NOT HAPPY AND WANTS NEAR VISION POST OP GOAL WITH A REMOVAL AND REPLACEMENT(EXPLANT). THE PATIENT'S OUTCOME IS 20/15-1 DISTANCE VISUAL ACUITY 20/60 NEAR VISUAL ACUITY AND 20/40 INTERMEDIATE POSTOP. THE CUSTOMER REPORTED THEIR PATIENT'S PRE VISUAL ACUITY AS 20/100 AND POST VISUAL ACUITY AS 20/15-. THE PROBLEM WAS OBSERVED UPON POST OPERATIVE EXAMINATION OF THE OPPOSITE EYE(SPECIFIC EYE WAS NOT PROVIDED). THE PATIENT TRIED TO LIVE WITH THE VISUAL OUTCOME AFTER SURGERY BUT HE REQUIRED GLASSES FOR ALL NEAR AND INTERMEDIATE TASKS. THE IOL WAS AND EXPLANTED AND REPLACED WITH LENS MODEL ZCU150 SERIAL NUMBER (B)(4). DURING THE EXPLANT IT WAS REQUIRED TO ENLARGE THE INCISION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10671035 ↗
• InjuryJan 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZCT150 16.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) ON (B)(6) 2019. THE ZCT150 16.0 DIOPTER LENS WAS EXPLANTED ON (B)(6) 2019 DUE TO COMPLAINT OF REFRACTIVE IOL ERROR DUE TO PREVIOUS PHOTOREFRACTIVE KERATECTOMY (PRK). THE LENS WAS REPLACED WITH AN ZCT150 17.5 DIOPTER LENS. IT WAS REPORTED THERE WAS NO COMPLICATIONS, NO INCISION ENLARGEMENT, NO VITRECTOMY, AND THE LENS IS NOT BEING RETURNED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9572513 ↗
• InjuryApr 25, 2018Migration or Expulsion of Device; Unintended Movement; Appropriate Device Problem Term/Code Not Available; Migration or Expulsion of Device; Unintended Movement; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DOCTOR IS PLANNING TO PERFORM A REVERSE OPTIC CAPTURE AND ALSO A LENS ROTATION FOR TECNIS TORIC INTRAOCULAR LENS (MODEL ZCT150 +16.0 DIOPTER) BECAUSE THE LENS ROTATED 22 DEGREES POST OP AND THE PATIENT IS A LITTLE HYPEROPIC. ALSO, DOCTOR REPORTED LENS DISLOCATION AND HAPTICS WERE TOO SHORT. THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7463450 ↗
• InjuryAug 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AS A TECNIS TORIC INTRAOCULAR LENS (IOL), MODEL ZCT150 16.0 DIOPTERS, WAS IMPLANTED INTO THE PATIENT'S LEFT EYE AND THE FRONT HAPTIC TORE THROUGH THE CAPSULAR BAG. THE LENS REMAINS IMPLANTED, A VITRECTOMY WAS PERFORMED, AND THE PATIENT WAS REFERRED TO A RETINA SPECIALIST TO HAVE THE LENS EXPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; No Code Available

  MAUDE report 6809271 ↗
• InjuryAug 17, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A TECNIS TORIC INTRAOCULAR LENS (IOL), MODEL ZCT150 16.0 DIOPTER, WAS IMPLANTED ON (B)(6)2017. HOWEVER, THE LENS LANDED 1.5 FROM INTENDED TARGET AND WAS THEREFORE EXPLANTED ON (B)(6)2017. THE REPLACEMENT LENS WAS A TECNIS TORIC IOL, MODEL ZCT150 18.0 DIOPTERS. THERE WAS NO CAPSULAR TEAR OR VITRECTOMY. THE PATIENT IS DOING WELL, THE PATIENT¿S UNCORRECTED VISUAL ACUITY IS 20/20 +2, AND POST OP REFRACTION IS: PLANO -0.5 X 145 20/20+2. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6802258 ↗