TECNIS IOL ZCT150 (REF ZCT150U220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05050474552180), received between Feb 21, 2017 and Jan 24, 2022 — classified as 10 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJan 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CAPSULAR BAG WOULD NOT HOLD THE INTRAOCULAR LENS (IOL). NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 13338469 ↗
• InjuryMar 9, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) ROTATED (DISLOCATED) DUE TO A COMPROMISED CAPSULAR BAG THAT OCCURRED BACK IN 2019. THE LENS WAS EXPLANTED FROM THE PATIENT'S EYE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 11449246 ↗
• InjuryDec 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZCT150 INTRAOCULAR LENS(IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE DUE TO DYSPHOTOPSIA. NO MEDICAL/ SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, SUTURES OR INCISION ENLARGEMENT WERE PERFORMED. THE REPLACEMENT LENS USED IS A NON J&J LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 10998903 ↗
• InjuryAug 6, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) ROTATED 30 DEGREES AND WAS NOTED TO MANIFEST AS DECREASED VISUAL ACUITY. THEREFORE, THE IOL WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE. IT WAS REPLACED WITH A DIFFERENT MODEL IOL, 21.5 DIOPTER POWER. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, OR NO SUTURES REQUIRED. THERE WAS NO PATIENT INJURY POST-OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 10377035 ↗
• MalfunctionMar 13, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE INNER PACKAGING THAT CONTAINED THE LENS WAS NOT SEALED AND THE LENS FELL OUT OF THE PACKAGING WITHOUT BREAKING THE PEEL PACK. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8415354 ↗
• InjuryFeb 10, 2019Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT A ZXT150 22.0 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO UNKNOWN REASONS. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 21.0. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8324759 ↗
• MalfunctionDec 6, 2018Mechanical Problem; Failure to Unfold or Unwrap; Mechanical Problem; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT A ZCT150 22.0 DIOPTER LENS WAS FULLY IMPLANTED INTO THE PATIENT'S OPERATIVE EYE, BUT THE HAPTICS DIDN'T UNFOLD. THEREFORE, THE DOCTOR TRIED MANUALLY UNFOLDING THE HAPTICS, BUT DAMAGED THE LENS BY DOING SO. THE LENS WAS THEREFORE REMOVED AND REPLACED WITH A BACK UP LENS IN WHICH THE MODEL AND DIOPTER WAS NOT REPORTED. REPORTEDLY, THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8140487 ↗
• InjuryOct 31, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZCT150 22.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018, DUE TO ANSIOMETROPIA. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS THE SAME MODEL, A SMALLER DIOPTER LENS. REPORTEDLY, THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8026289 ↗
• InjuryMay 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A VITRECTOMY PERFORMED, AND BECAUSE OF THIS, THE INITIALLY CHOSEN LENS (ZCT150 22.0 DIOPTER LENS) WAS NOT USED AND A DIFFERENT LENS WAS THEN USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vitrectomy

  MAUDE report 7493224 ↗
• InjuryMay 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE ZCT150 22.0 DIOPTER INTRAOCULAR LENS (IOL) WAS INSERTED, A CAPSULE TEAR OCCURRED. THE DOCTOR PERFORMED VITRECTOMY. THE LENS WAS REMOVED AND REPORTEDLY IT WAS REPLACED WITH A SULCUS 3 PIECE LENS. THERE WERE NO OTHER INTERVENTIONS REQUIRED AND THE PATIENT OUTCOME AT THE TIME OF DISCHARGE WAS GOOD. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 7492234 ↗
• InjurySep 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT150 22.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017, BECAUSE OF RESIDUAL ASTIGMATISM. THE LENS WAS REPLACED WITH NON-AMO IOL. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6878117 ↗
• InjuryFeb 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT150 22.0 DIOPTER LENS WAS EXPLANTED FROM A FEMALE PATIENT¿S LEFT EYE DUE TO PATIENT¿S MYOPIC OUTCOME. THE PHYSICIAN NOTED THAT THE PATIENT HAD NO PRIOR LASIK PROCEDURES. IN ADDITION THERE WAS NO INCISION ENLARGEMENT OR SUTURES REQUIRED. THE LENS WAS REPLACED WITH ANOTHER ZCT150 MODEL LENS OF A LOWER DIOPTER POWER (19.5). THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Code Available

  MAUDE report 6344630 ↗