TECNIS IOL ZCT150 (REF ZCT150U175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474552098), received between Mar 30, 2018 and May 18, 2021 — classified as 9 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT150 MODEL INTRAOCULAR LENS(IOL) WAS IMPLANTED AND THEN CUT IN HALF TO REMOVE DUE TO A ZONULAR DEFECT. CUSTOMER DOES NOT HAVE THE LENS SINCE THEY CUT IT OUT. THERE WAS NO PATIENT INJURY AND NO MEDICAL/ SURGICAL INTERVENTIONS SUCH AS SUTURES OR VITRECTOMY WAS PERFORMED BUT INCISION WAS ENLARGED. PROCEDURE WAS COMPLETED SUCCESSFULLY USING A NON JOHNSON AND JOHNSON SURGICAL VISION LENS. PATIENT WAS DOING WELL DOING THE POST-OP. NO FURTHER INFORMATION AVAILABLE.

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

  MAUDE report 11845065 ↗
• InjuryMay 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT ONE OF HIS PATIENTS WILL UNDERGO A TORIC INTRAOCULAR LENS (IOL) EXCHANGE. THE LENS WAS ORIGINALLY IMPLANTED ON (B)(6) 2020, AND THE PATIENT IS NOW HYPEROPIC AND UNHAPPY. THE PATIENT HAD PRIOR MYOPIC LASIK ON BOTH EYES SO SELECTING THE BEST STRENGTH IOL WAS MORE DIFFICULT. PREOP KERATOMETRY (ZEISS ATLAS) 37.32/ 38.65 X 007. PREOP MEASUREMENTS WERE RUN ON ASCRS HILL/WANG/KOCH POST REFRACTIVE. AT ONE-MONTH POST-OPERATION ON (B)(6) 2021: UNCORRECTED VISUAL ACUITY (UCVA) = 20/70, REFRACTION = +2.00 -1.00 X 040= 20/25. MARCO OPD-3 SHOWS TORIC IOL ORIENTED AT 20 DEGREES WHILE THE AXIS OF ASTIGMATISM IS 170 DEGREES. THE PATIENT WAS EXAMINED TWICE, AND THE SURGEON SUGGESTED THAT HE NEEDS AN IOL EXCHANGE WITH +20.50 DIOPTER ZCT150 ORIENTED AT 173 DEGREES. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE PATIENT UNDERWENT THE IOL EXCHANGE IN HIS RIGHT EYE. THE REPLACEMENT LENS IS THE SAME MODEL AT A HIGHER DIOPTER, 20.5. REPORTEDLY, THE PATIENT POST-OP COURSE WAS BENIGN AND HE NOW HAS AN UNCORRECTED DISTANCE VISION OF 20/25. HE IS VERY PLEASED WITH THE RESULTS.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 11792348 ↗
• InjurySep 21, 2020Adverse 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 FROM THE PATIENT'S OPERATIVE EYE. THROUGH FOLLOW-UP, IT WAS LEARNED PATIENT HAD VISION CORRECTION ENHANCEMENT ON (B)(6) 2019. THE LENS WAS EXPLANTED AS THE PATIENT HAD A POOR VISUAL OUTCOME. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND LOWER DIOPTER) WAS SUCCESSFULLY IMPLANTED AS A REPLACEMENT. THE PATIENT WAS DISCHARGED IN GOOD CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10564640 ↗
• InjuryApr 27, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A MODEL ZCT150 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE DUE TO ROTATION OF THE IOL. DESPITE FOLLOW-UP ATTEMPTS, NO RESPONSE HAS BEEN RECEIVED. NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 8558847 ↗
• InjuryJan 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD 5 DIOPTER HYPEROPIC MISS AFTER THE IMPLANTATION OF MODEL ZCT150 +17.50 DIOPTER TORIC IOL (INTRAOCULAR LENS) IN HER LEFT EYE (OS). THE IOL MASTER PREDICTED A PLANO RESULT WITH THIS LENS AND THE LENS APPEARS FINE AT POST-OP AS IT IS NOT SITTING POSTERIOR. THROUGH FOLLOW-UP, THERE WERE NO OTHER VISUAL ISSUES REPORTED OTHER THAN THE PATIENT BEING A +4.00 POST-OP AND PATIENT BEING UNHAPPY WITH HER VISUAL ACUITY. IT WAS ALSO INDICATED THAT THE PATIENT HAS PSEUDOEXFOLIATION (PXS) SYNDROME IN HER RIGHT EYE (OD). THE DOCTOR HAS NOT YET MADE THE DECISION WHETHER IT WOULD BE BEST TO EXPLANT THE LENS OR TO DO A PIGGYBACK IOL IN THE SETTING OF PXS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8259707 ↗
• InjuryOct 20, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZCT150 17.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2015. IT WAS LATER EXPLANTED ON (B)(6) 2015 BECAUSE THE PATIENT WAS HAVING DIFFICULTY WITH THEIR VISION. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 19.5. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7987905 ↗
• InjurySep 17, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZCT150 17.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED DUE TO A HYPEROPIC OUTCOME ON (B)(6) 2018. THE REPLACEMENT LENS WAS A ZCT150, A LARGER 18.5 DIOPTER LENS. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED. REPORTEDLY, THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7883789 ↗
• InjuryJul 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ZCT150 + 17.5 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE (OS). PER ACCOUNT, PATIENT WAS UNHAPPY WITH LOSS OF NEAR VISION. HOWEVER, THERE WAS NO PATIENT INJURY OCCURRED AND NO INCISION ENLARGEMENT REQUIRED. IOL EXCHANGED WITH THE SAME MODEL AND TYPE NUMBER WAS PERFORMED WITHOUT INCIDENT, BUT WITH DIFFERENT SERIAL NUMBER, (B)(4). IT WAS NOTED THAT PATIENT HAD PREEXISTING CONDITION, GLAUCOMA. PATIENT BEST CORRECTED VISUAL ACUITY RESULTS WERE 20/25 PRE-OPERATION AND 20/20 POST-OPERATION. PRODUCT IS NOT EXPECTED TO BE RETURNED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7657139 ↗
• InjuryMar 30, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT150 17.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. AT THE PATIENT'S 1 DAY POST-OPERATIVE VISIT WITH THE DOCTOR, IT WAS NOTICED THAT THE LENS ROTATED 60 DEGREES FROM ITS ORIGINAL AXIS OF 180. THE DOCTOR WAS SURPRISED BY THIS BECAUSE THE PATIENT SEEMED TO HAVE AN AVERAGE LOOKING SIZED EYE WITH AN AXIAL LENGTH OF ABOUT 24.8. THE LENS LOOKED SNUG WHEN SURGERY WAS DONE AS WELL. THE DOCTOR ALSO REPORTED THAT HE KNEW THERE WAS AN ISSUE WHEN HE NOTICED THE PATIENT WAS 20/50 FOR DISTANCE. THE DOCTOR SAID HE DOESN'T THINK THAT VISCOAT WAS USED TO LOAD THE LENS AND THAT HE USED PROVISC TO FILL BAG AND WORKED TO MAKE SURE IT WAS ALL OUT. THE DOCTOR IS CONSIDERING REPOSITIONING THE LENS AT 2 WEEKS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 7387357 ↗