TECNIS IOL ZCT150 (REF ZCT150U215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05050474552173), received between Sep 9, 2016 and Jun 12, 2021 — classified as 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Torn Material” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS NOT SATISFIED WITH THE LENS IMPLANTED IN HER EYE. THE PATIENT STATES THAT HER VISION WAS BLURRY AND NOT CLEAR AS HER FIRST EYE. THE EYE AFFECTED COULD NOT BE CONFIRMED. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS OF SAME MODEL ZCT150 BUT DIFFERENT DIOPTER 23.0. THE PATIENT WAS TEMPORARILY IMPAIRED. THE EVENT WAS OBSERVED DURING THE POST OPERATIVE EXAMINATION. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 11988618 ↗
• InjuryJul 24, 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 RIGHT EYE DUE TO BLURRY VISION WITH FLASHES AND FLOATERS. THE VISUAL ACUITY (VA) PRE-OP 20/30, VA ONE DAY POST-OP 20/60. IT WAS STATED THAT THE INCISION WAS ENLARGED AND THAT SUTURES WERE USED. A DIFFERENT MODEL AND HIGHER DIOPTER (25.0) WAS USED AS REPLACEMENT IOL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances; Vitreous Floaters

  MAUDE report 10324121 ↗
• InjurySep 17, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT TECNIS TORIC INTRAOCULAR LENS (MODEL ZCT150 +21.5 DIOPTER) WAS IMPLANTED IN PATIENT¿S LEFT EYE ON (B)(6) 2018. LATER, ON (B)(6) 2019 SURGEON OBSERVED THE LENS ROTATED TO 153 DEGREES. ROTATION OF THE LENS WAS DONE ON (B)(6) 2019 TO 126 DEGREES. REPORTEDLY PATIENT WAS EXPERIENCING BLURRY VISION, GLARE, COATING ACROSS HER VISION, HEADACHES, NAUSEA SINCE SURGERY. PATIENT IS HAPPY WITH THE VISION. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; Headache; Visual Disturbances

  MAUDE report 9074203 ↗
• InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CAPSULE TORE AT SURGEON AND PATIENT INTERFACE WHILE INSERTING LENS INTO THE EYE. THE LENS WAS REMOVED AND REPLACED IN SAME SURGICAL PROCEDURE. REPORTEDLY ANTERIOR CHAMBER LENS WAS PLACED IN PATIENT¿S OPERATIVE EYE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 8951861 ↗
• InjuryMay 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST IMPLANT OF A MODEL ZCT150 21.5 DIOPTER INTRAOCULAR LENS (IOL) INTO THE PATIENT¿S LEFT EYE, THERE WAS HYPEROPIC SURPRISE. THE IOL WAS STILL ON AXIS SHOWING REFRACTION OF +1.50 -1.25 X 71, HYPEROPIA HAD GRADUALLY INCREASED SINCE THE IOL WAS IMPLANTED IN THE EYE. THE PATIENT EXPERIENCED BLURRY DOUBLE VISION IN BOTH DISTANCE AND NEAR VISION. THE LENS WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH A MODEL ZCT225 22.5 DIOPTER LENS. AT EXPLANT IT WAS REPORTED AN INCISION ENLARGEMENT WAS REQUIRED, HOWEVER LATER INFORMATION PROVIDED STATED THERE WERE NO COMPLICATIONS. PATIENT OUTCOME POST EXCHANGE WAS NOT PROVIDED. VISUAL ACUITY PRE-OPERATIVE 20/60. VISUAL ACUITY POST-OPERATIVE 20/40+1. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8592097 ↗
• InjuryMay 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS TORIC INTRAOCULAR LENS (MODEL ZCT150 +21.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S OPERATIVE EYE BECAUSE OF PATIENT EXPERIENCING ANISOMETROPIA. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES REQUIRED. REPORTEDLY LENS WITH MODEL ZCT225 +22.5 DIOPTER WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. PATIENT WAS DOING FINE POST EXCHANGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8576322 ↗
• InjuryApr 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT REPORTED A BILATERAL INTRAOCULAR LENS (IOL) IMPLANT. THE FIRST LENS WAS IMPLANTED IN HER RIGHT EYE (OD) ON (B)(6) 2018 AND THE SECOND LENS WAS IMPLANTED IN HER LEFT EYE (OS) ON (B)(6) 2018. THE PATIENT INFORMED HER SURGEON, DURING ROUTINE FOLLOW UP VISITS, THAT IMMEDIATELY AFTER SURGERY SHE STARTED EXPERIENCING SOME VISUAL ISSUES. ON HER LAST VISIT TO THE SURGEON IN (B)(6) 2019, A 2ND YAG PROCEDURE WAS PERFORMED, ONE IN EACH EYE TO TRY TO IMPROVE THINGS. ALSO EYE DROP MEDICATIONS WERE PRESCRIBED FOR HER EYES. DESPITE HER VISUAL ACUITY IS AT 20/20, SHE CONTINUES TO SEE A FILM MOVING OVER HER EYES WHEN IN NATURAL DAYLIGHT AND GLARE WITH ANY LIGHT SOURCE; ESPECIALLY, ARTIFICIAL LIGHT. SHE ALSO MENTIONED THAT HER PERIPHERAL VISION SEEMS TO BE DIMINISHED AND SHE FEELS LIKE SHE CAN ACTUALLY SEE THE EDGES OF THE LENS LIKE A LINE IN HER VISION. THE PATIENT COMMENTED THAT THE SYMPTOMS INTERFERE WITH HER NORMAL ACTIVITIES INCLUDING NIGHT DRIVING. HER SURGEON DOES NOT UNDERSTAND WHY SHE HAS THESE SYMPTOMS, BUT THERE IS NO PLAN FOR A FUTURE TREATMENT SUCH AS LENS EXCHANGE OR PRESCRIPTION GLASSES. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT PERTAINS TO THE RIGHT EYE. A SEP

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8508487 ↗
• InjuryJun 6, 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, +21.5 DIOPTER) WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE BECAUSE THE PATIENT COULD NOT TOLERATE THE LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7572688 ↗
• InjuryApr 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 21.5 DIOPTER LENS WAS IMPLANTED IN A PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO POST-OP DYSPHOTOPSIA AND REPLACED WITH A ZCT150 21.5 DIOPTER LENS AT AXIS 93. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7456974 ↗
• InjuryMar 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT150 21.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018, BECAUSE THE PATIENT COULD NOT SEE WELL POST-OPERATIVELY. THE REPLACEMENT LENS WAS A ZCB00 24.0 DIOPTER LENS. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 7376178 ↗
• InjuryDec 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT150 21.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. POST-OPERATIVELY, THERE WAS A SURPRISE OUTCOME WITH THE ASTIGMATIC PATIENT. THERE WERE SEVERAL CORNEAL MEASUREMENTS PRE-OPERATIVELY, WHICH SUGGESTED A TORIC LENS FOR THE PATIENT, BUT THE PATIENT HAD 1 - 1.5 DIOPTERS OF CYLINDER IN THE OPPOSITE ACCESS. THE PATIENT'S PRE-OPERATIVE VISUAL ACUITY WAS 20/50 WITHOUT CORRECTION AND POST-OPERATIVELY VISION WAS ALSO 20/50 UNCORRECTED. VISUAL ACUITY FOR BOTH EYES PRE-OPERATIVELY WERE 20/20. POST-OPERATIVELY, ONE WEEK AFTER SURGERY, THE PATIENT STILL COMPLAINED OF BLURRY VISION AND THE MANIFEST REFRACTION HAD UNEXPECTED RESULTS. PRE-OPERATIVE AUTO REFRACTION RESULTS WERE +2.00 X -1.50 X 104 AND POST-OPERATIVE REFRACTION RESULTS WERE +0.75 X -1.50 X 10 WITH A BEST CORRECTED VISUAL ACUITY OF 20/15. THERE IS A PLANNED EXPLANT SCHEDULED FOR (B)(6) 2017 NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7156213 ↗
• InjuryApr 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT A TECNIS MONOFOCAL MODEL ZCT150 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT¿S OPERATIVE EYE AS THERE WAS VISUAL DISTURBANCES AND EXPECTED (WANTED) NEAR VISION. ALTHOUGH ATTEMPTS WERE MADE, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6521099 ↗
• MalfunctionJan 16, 2017Torn Material; Torn Material

  THE INTRAOCULAR LENS (IOL) GOT STUCK IN THE CARTRIDGE. THE DOCTOR THOUGHT SHE COULD GET IT IN THE EYE AND ATTEMPTED DELIVERY. THE IOL WAS INSERTED IN THE PATIENT'S EYE BUT HAD TO BE REMOVED AS IT TORE. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6254325 ↗
• InjurySep 9, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTATION OF A ZCT150 INTRAOCULAR LENS (IOL) IN BOTH EYES, THE PATIENT EXPERIENCED GREAT DEAL OF TROUBLE UNDER FLUORESCENT LIGHTING. PATIENT IS HAVING HARD TIME WORKING ON THE COMPUTER, IS UNCOMFORTABLE AND HAS TROUBLE SEEING, FOCUSING, COMPLETING WORK BUT IS FINE OUTSIDE. PER THE PATIENT ACCORDING TO HER DOCTOR, HER EYES ARE HEALTHY AND SEEING PROPERLY. THIS REPORT REPRESENTS THE LENS IMPLANTED IN PATIENT'S LEFT EYE. A SEPARATE REPORT IS BEING FILED FOR THE LENS IMPLANTED IN PATIENT'S RIGHT EYE.

  Patient problems: Discomfort; Visual Disturbances

  MAUDE report 5941106 ↗