TECNIS IOL ZCT150 (REF ZCT150U235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474552210), received between Jun 20, 2017 and Feb 20, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (2 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Jan 27, 2021Terminated

   Due to the release of nonconforming Intraocular Lenses (IOLs).

   Z-1163-2021 · Root cause: Process change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NON PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED WITH UNKNOWN REASON OF EXPLANT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 21423704 ↗
• InjuryDec 8, 2020Device Markings/Labelling Problem; Inaccurate Information; Device Markings/Labelling Problem; Inaccurate Information

  IT WAS REPORTED INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). IOL WAS EXPLANTED DUE TO COMPLAINT OF SIGNIFICANTLY HYPEROPIC AND REPLACED WITH A DIFFERENT MODEL AND DIFFERENT DIOPTER SIZE LENS. AFTER RUNNING NUMEROUS TESTS AND CHECKING HIS CALCULATIONS MULTIPLE TIMES, THE DOCTOR IS CONCERNED THE LENS IMPLANTED MAY BE MISLABELED. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING NORMAL DAILY ACTIVITIES ARE AFFECTED. THERE WERE NO COMPLICATIONS AND NO VITRECTOMY. PLANNED INCISION ENLARGEMENT WAS PERFORMED IN THE PRIMARY TEMPORAL WOUND AND ENLARGED TO ABOUT 3.0 MM. ONE (01) 10-0 NYLON SUTURE WAS PLACED; THIS WAS PLANNED TO BE DONE AT THE TIME OF IOL EXCHANGE. PATIENT OUTCOME WAS REPORTED AS: HEALING NORMALLY BUT HE IS NOW MYOPIC (ABOUT -2.00 BUT PENDING FINAL REFRACTION IN A FEW WEEKS). HE WILL NOW REQUIRE FULL TIME GLASSES OR CTL WEAR OR A 3RD SURGERY (LASIK OR PRK) TO GIVE HIM THE INTENDED REFRACTIVE OUTCOME. IN THE DOCTOR'S OPINION, THIS UNINTENDED REFRACTIVE OUTCOME IS A DIRECT RESULT OF THE IOL BEING MISLABELED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10972687 ↗
• InjuryJan 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT150 23.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT EXPERIENCED DOUBLE VISION 2 WEEKS POST-OPERATIVELY AND WAS SEEING A RING OF WHITE LIGHT INFERIORLY. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE PATIENT'S VISUAL ACUITY PRE-OPERATIVELY WAS 20/30 AND POST-OPERATIVELY WAS 20/25 WITH GHOSTING. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 8269764 ↗
• InjuryDec 22, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT TECNIS TORIC INTRAOCULAR LENS (MODEL ZCT150 23.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S OPERATIVE EYE BECAUSE OF PATIENT EXPERIENCING UNEXPECTED POST OP REFRACTION. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. LENS WITH SAME MODEL AND LARGER DIOPTER WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. PATIENT WAS REPORTED TO BE DOING WELL. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8192846 ↗
• InjuryOct 7, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE TECNIS TORIC INTRAOCULAR LENS (MODEL ZCT150, +23.5 DIOPTER) ROTATED AFTER IT WAS IMPLANTED IN PATIENT¿S LEFT EYE. THE DEGREE OF ROTATION WAS NOT PROVIDED. IT WAS LEARNT THAT DURING THE POST OP VISIT, DAY SEVEN (7), PATIENT WAS EXPERIENCING BLURRY VISION. PATIENT FURTHER STATED SHE HAD BLURRY VISION SINCE THE SURGERY. ONE DAY POST OP, (B)(6) 2018, THE UNCORRECTED VISUAL ACUITY WAS 20/30-1, PINHOLE WAS 20/20-2. ADDITIONAL INFORMATION WAS RECEIVED, WHERE IT WAS REPORTED THAT THE DOCTOR RESET (ROTATED) THE LENS CORRESPONDING TO A REFRACTION WITH AN AXIS OF 131 DEGREES. THE DATE OF LENS ROTATION WAS NOT PROVIDED; HOWEVER, WAS STATED AS PLANNED/SCHEDULE THE WEEK OF (B)(6) 2018. PATIENT WAS PRESCRIBED LOTEMAX 0.5% AND AZOPT 1%, WITH CONTINUED USE OF LUMIGAN AND COMBIGAN AT POST OP VISIT, (B)(6) 2018. UNCORRECTED VISUAL ACUITY 20/40-2. BEST CORRECTION FINAL VISUAL ACUITY AS 20/20-2. DOCTOR NOTED PATIENT'S IOP (INTRAOCULAR PRESSURE) WAS UP IN BOTH EYES AND PATIENT IS A STEROID RESPONDER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Intraocular Pressure Increased; Visual Impairment

  MAUDE report 7941689 ↗
• InjuryJan 3, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZCT150 23.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS). IT WAS LATER EXPLANTED ON (B)(6) 2017 BECAUSE THE PATIENT COMPLAINED OF LIGHTING BEING VERY BRIGHT, SEEING WHITE CIRCLES OF LIGHT FROM THE BOTTOM TO THE TOP OF THE LEFT EYE, AND THE INABILITY TO READ STREET SIGNS WELL. FURTHERMORE, THE PATIENT STATED SHE IS HAVING TROUBLE WALKING AND EVERYTHING SEEMS OVEREXPOSED. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR CAPSULAR TEAR. THE LENS WAS REPLACED WITH THE SAME MODEL, BUT DIFFERENT DIOPTER OF 22.5. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT WAS REPORTED AS BEING OKAY THE DAY AFTER SURGERY UP TILL ABOUT 10 DAYS POST-OP. THE EXPLANTED LENS IS NOTED TO NOT BE AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances; Visual Impairment

  MAUDE report 7162464 ↗
• InjuryJun 20, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT AFTER IMPLANTATION OF A ZCT150 23.5 DIOPTER INTRAOCULAR LENS (IOL), THE LENS HAD ROTATED ABOUT 45 DEGREES AND IOL IS OFF BY A DIOPTER. FURTHERMORE, THE PHYSICIAN INDICATED HAVING SOME COMPLICATIONS REGARDING REMOVAL OF LENS. THE LENS WAS REPLACED WITH A 3 PIECE LENS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 6655685 ↗