TECNIS IOL ZCT150 (REF ZCT150U190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474552128), received between Nov 22, 2016 and Mar 19, 2020 — classified as 9 injuries.

The most frequently reported specific device problem is “Break” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE DUE TO IOL ROTATED AS WELL AS THE POWER WAS OFF, AND SPECIFIC VISUAL ISSUES. THE LENS WAS REPLACED WITH A MODEL ZCU 19.5 DIOPTER LENS. NO PROBLEMS WITH PATIENT POST-OP. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 9851738 ↗
• InjuryMar 4, 2020Adverse 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 IMPLANTED IN THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2020 DUE TO UNEXPECTED POST-OP REFRACTION. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION REQUIRED. REPORTEDLY, PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9785129 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED RESIDUAL HYPEROPIC SURPRISE IN THE LEFT EYE POST-IMPLANT OF A MODEL ZCT150 INTRAOCULAR LENS. AT EXPLANT THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. ANOTHER LENS (SAME MODEL, HIGHER DIOPTER) WAS IMPLANTED AS THE REPLACEMENT. THERE WERE NO COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 9522021 ↗
• InjuryApr 26, 2019Break; Device Handling Problem; Break; Device Handling Problem

  IT WAS INITIALLY REPORTED THAT THE CUSTOMER EXPERIENCED ISSUES WITH TWO DIFFERENT MODEL ZCT INTRAOCULAR LENSES ONE AFTER THE OTHER WITH THE SAME PATIENT. THE FIRST ZCT150 WAS NOTED TO BE CRACKED WHEN INSERTED INTO THE EYE. HENCE, IT WAS REMOVED. BUT INCISION WAS ENLARGED AND VITRECTOMY WAS ALSO PERFORMED. THIS WAS REPLACED WITH A SECOND ZCT150 WHICH ALSO WAS CRACKED, THEREFORE ALSO REMOVED. THE CUSTOMER THEN LOADED A MODEL PCB00 IOL. BUT THIS LENS GOT STUCK IN CARTRIDGE DURING HANDLING PRIOR TO INSERTION AND WAS NEVER IMPLANTED. THE DOCTOR THOUGHT IT COULD BE DUE TO TECH ERROR. A SECOND MODEL PCB00 IOL WAS INSERTED INTO THE PATIENT¿S EYE BUT THE PATIENT'S CAPSULAR BAG WAS COMPROMISED, AND THE LENS FELL TO BACK OF THE EYE. THE DOCTOR LEFT THIS SECOND PCB00 IMPLANTED. THE FOLLOWING DAY, THE PATIENT WENT TO A RETINA SURGEON. CONTACT PERSON DOESN''T KNOW NOW OF PATIENT OUTCOME. SHE STATED THAT AS THE SURGEON WAS A LOCUM¿S PHYSICIAN, (TEMPORARY PHYSICIAN), THEREFORE THEY DON''T HAVE HIS CONTACT INFORMATION. THE CONTACT PERSON ALSO DOES NOT HAVE A PHONE NUMBER FOR THE PATIENT. CONTACT PERSON NOTED THAT DOCTOR THINKS THERE WAS NO PRODUCT QUALITY ISSUE AND THAT EVENTS WERE ALL DUE TO TECH

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 8558581 ↗
• InjuryFeb 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT150 19.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS NOTED THE LENS WAS PUT IN AT SEVENTEEN DEGREES (17°) (PENTACAM KS). POST-OP MARKS AT/OR VERY CLOSE TO 17 DEGREES, MANIFEST REFRACTION (MR) -0.25 + 1.50 X 05. THE LENS WAS LATER EXPLANTED ON (B)(6) 2019 BECAUSE THE PATIENT COMPLAINED OF BLURRY VISION AND FLASHES OF LIGHT ONE DAY AFTER THE INITIAL SURGERY. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS A ZCT300 20.0 DIOPTER IOL. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 8308653 ↗
• InjuryApr 20, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZCT150 19.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018, BECAUSE THE PATIENT NEEDED A HIGHER DIOPTER POWER. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS THE SAME MODEL, HIGHER DIOPTER OF 20.0. REPORTEDLY, THERE WAS NO PATIENT INJURY. ON (B)(6) 2018, THE PATIENT'S VISUAL ACUITY WAS 20/20. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7448654 ↗
• InjuryJun 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS TORIC INTRAOCULAR LENS (IOL), MODEL ZCT150 WAS EXPLANTED IN A SECOND SURGERY, FROM THE PATIENT'S RIGHT EYE (OD). THE IOL WAS EXCHANGED WITH A DIFFERENT TORIC LENS. IT WAS REPORTED THAT THERE WAS NO DEVICE ISSUE AS THIS WAS AN UNPREDICTABLE ASTIGMATISM AFTER LASIK/RESULTED IN MORE ASTIGMATISM THAN PREOPERATIVELY. IT WAS REPORTED THAT THE IOL WAS CUT INTO SMALL PIECES TO REMOVE AT TIME OF SURGERY AND THAT THERE WAS NO INCISION ENLARGEMENT REQUIRED, NO VITRECTOMY PERFORMED AND NO SUTURES NEEDED. THERE WAS NO PATIENT INJURY POST-OP REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6616470 ↗
• InjuryMay 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT150 19.0 DIOPTER INTRAOCULAR LENS WAS EXPLANTED FROM A FEMALE PATIENT'S RIGHT EYE DUE TO A REFRACTIVE ERROR. THE LENS WAS REPLACED WITH THE SAME MODEL LENS WITH A LOWER DIOPTER (17.5). THERE WAS NO INCISION ENLARGEMENT AND NO SUTURES REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6590032 ↗
• InjuryNov 22, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE RIGHT EYE OF A (B)(6) FEMALE PATIENT. THE SURGEON HAS PLANNED TO EXCHANGE THIS LENS (WITH A NEW LENS, UNKNOWN MODEL AND DIOPTRE) ON (B)(6) 2016, AS THE PATIENT HAS BEEN HAVING ISSUES (VISUAL DISTURBANCE) SEEING "FERRIS WHEEL". NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6123027 ↗