TECNIS IOL ZCT150 (REF ZCT150U155)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474552050), received between Jun 21, 2018 and Mar 17, 2020 — classified as 7 injuries.

The most frequently reported specific device problem is “Failure to Unfold or Unwrap” (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. How this data works · Data updated Oct 13, 2026.

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.

• InjuryMar 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HYPEROPIC POST-IMPLANT OF A MODEL ZCT150 INTRAOCULAR LENS (IOL) IN THE LEFT EYE. THEREFORE, THE LENS WAS EXPLANTED. THERE WERE NO SUTURES OR VITRECTOMY REQUIRED. THE PATIENT IS REPORTED TO BE DOING OKAY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 9840525 ↗
• InjuryNov 2, 2019Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT A ZCT150, 15.5 DIOPTER LENS WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE DUE TO AN ISSUE WITH THE LENS. THE LENS WAS REPLACED WITH THE SAME MODEL BUT A SMALLER 12.0 DIOPTER LENS. THROUGH FOLLOW-UP, THE CUSTOMER EXPLAINED THAT THE WRONG LENS POWER WAS USED. THEY COULD NOT CONFIRM IF THERE WAS SOMETHING WRONG WITH THE IOL. THERE WERE NO COMPLICATIONS OF ANY KIND SUCH AS INCISION ENLARGEMENT, VITRECTOMY, CAPSULE TEAR OR SUTURES REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9269801 ↗
• InjuryOct 17, 2019Failure to Unfold or Unwrap; Appropriate Device Problem Term/Code Not Available; Failure to Unfold or Unwrap; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED A MODEL ZCT150 15.5 DIOPTER INTRAOCULAR LENS (IOL) FLIPPED UPSIDE-DOWN AFTER BEING INSERTED IN THE PATIENT¿S OPERATIVE EYE. THE LENS WAS REMOVED WITHOUT PATIENT INJURY AND NO SUTURE(S) REQUIRED, HOWEVER THE INCISION WAS ENLARGED. THE PROCEDURE WAS COMPLETED USING ANOTHER LENS OF THE SAME MODEL. THE REMOVED ZCT150 LENS IS NOT BEING RETURNED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 9205154 ↗
• InjuryMar 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO A GOAL CHANGE. THE EXPLANTED LENS WAS EXCHANGED FOR A DIOPTER MODEL BUT SAME DIOPTER IOL. PATIENT OUTCOME WAS NOTED AS ALRIGHT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8458626 ↗
• InjuryOct 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TECNIS TORIC INTRAOCULAR LENS (MODEL ZCT150, +15.5 DIOPTER) WAS IMPLANTED, REMOVED AND REPLACED IN THE SAME PROCEDURE AS THE PATIENT MOVED AND THE CAPSULE RUPTURED. REPORTEDLY, A THREE-PIECE INTRAOCULAR LENS WAS IMPLANTED AS A REPLACEMENT. NO INCISION ENLARGEMENT, NO VITRECTOMY WAS PERFORMED AND NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 7959719 ↗
• InjuryAug 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR ORDERED A SYMFONY INTRAOCULAR LENS, (IOL), MODEL ZXT150, 15.5 DIOPTER FOR HIS PATIENT. THE LENS WAS ORDERED; HOWEVER, A MODEL ZCT150, 15.5 DIOPTER WAS SENT IN ERROR. THE SURGERY SITE RECEIVED THE ZCT150, 15.5 DIOPTER AND THE LENS WAS IMPLANTED. FOLLOWING THE IMPLANT, THE DOCTOR REALIZED THE ERROR. THE DOCTOR STATED HE MAY NEED TO EXPLANT THE LENS. NO PATIENT SYMPTOMS WERE REPORTED AND NO ADDITIONAL INFORMATION PROVIDED. THE DIRECTIONS FOR USE (DFU) CLEARLY STATE TO EXAMINE THE PRODUCT PRIOR TO USE INCLUDING CHECKING THE IOL TYPE, POWER, PROPER CONFIGURATION AND EXPIRATION DATE.

  Patient problems: No Code Available

  MAUDE report 7790843 ↗
• InjuryJun 21, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZCT150 15.5 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE LENS POWER WAS INCORRECT. THERE WAS NO INCISION ENLARGEMENT AND THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 14.0. REPORTEDLY, THE PATIENT IS DOING WELL. THE EXPLANTED LENS IS NOT BEING RETURNED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7624428 ↗