TECNIS IOL ZCT150 (REF ZCT150U230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05050474552203), received between Jan 5, 2017 and Aug 10, 2022 — classified as 8 injuries, 4 malfunctions.

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. 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.

• InjuryAug 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENSES (IOLS) WERE IMPLANTED, THE PATIENT IS EXPERIENCING HALOS IN BOTH EYES (OU) AND IS HAVING DIFFICULTY DRIVING AT NIGHT. THE PATIENT STILL DRIVES AT NIGHT BUT IS UNCOMFORTABLE. THE PATIENT REPORTED THAT READING SIGNS IS MORE DIFFICULT NOW AND NOT AS CLEAR AS RIGHT AFTER THE SURGERY. THE ISSUE HAS GOTTEN WORSE OVER TIME, AND NOW THE PATIENT CAN HARDLY READ STREET SIGNS. THE PATIENT HAS NOT STOPPED DOING DAILY ACTIVITIES, BUT JUST FINDS IT A LOT MORE DIFFICULT BECAUSE OF THE VISUAL ISSUES. THE PATIENT HAS NOT TRIED TO WEAR GLASSES AND STATED THAT THE DOCTOR HAS NOT RECOMMENDED IT. THE ISSUE STARTED OU A FEW MONTHS AGO. THE PATIENT COULD NOT PROVIDE AN EXACT DATE. THE DOCTOR IS RECOMMENDING A ¿LASER PROCEDURE¿ WHICH IS SUPPOSED TO HELP WITH THE VISUAL ISSUES, WHICH HAS NOT BEEN SCHEDULED YET. THE PATIENT REPORTED THAT THE DOCTOR ADVISED THAT THE MEMBRANE GREW BACK AND ¿COVERED IT¿, WHICH IS WHY THE ¿LASER PROCEDURE¿ IS REQUIRED. THROUGH FOLLOW-UP WITH THE DOCTOR¿S OFFICE, IT WAS REPORTED THAT THE PATIENT HAS POSTERIOR CAPSULAR OPACIFICATION (PCO) OU AND HAS YTTRIUM ALUMINUM GARNET (YAG) LASER PROCEDURE SCHEDULED OU. THE LEFT EYE (OS) YAG

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Dry Eye(s); Halo

  MAUDE report 15203532 ↗
• InjuryJul 8, 2020Break; Break

  IT WAS REPORTED THAT 1-MONTH POST OP THE ZCT LENS HAS WEIRD DEFECT IN THE POSTERIOR LENS ITSELF. HENCE THE SURGEON WAS PLANNING TO EXCHANGE THE LENS. ADDITIONAL INFORMATION INDICATES THE LENS WAS EXPLANTED IN SECONDARY SURGICAL PROCEDURE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10246784 ↗
• InjuryMay 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT REQUIRED A VITRECTOMY INVOLVING ZCT150 23.0 DIOPTER INTRAOCULAR LENS (IOL). NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Patient Involvement; Vitrectomy

  MAUDE report 8661128 ↗
• InjuryMay 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT A ZCT150 TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2019 DUE TO BLURRY VISION. THE SURGEON COMMENTED THAT THE PATIENT EXPERIENCED A REFRACTIVE SURPRISE, AND HER VISUAL ACUITY POST-OPERATIVELY IS 20/30 -2. IT WAS ALSO NOTED THAT THERE WAS NO SURGICAL INTERVENTION REQUIRED AND THE LENS WILL NOT BE RETURNED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8589406 ↗
• InjuryMar 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER INSERTION OF A MODEL ZCT150 TORIC IOL (INTRAOCULAR LENS) INTO A PATIENT'S LEFT EYE (OS), THERE WAS A CAPSULE TEAR WITH APPARENT VITREOUS FLUID LEAKING. AS A RESULT, A VITRECTOMY WAS PERFORMED, AND THE LENS WAS REMOVED FROM THE EYE REQUIRING AN INCISION ENLARGEMENT. PATIENT OUTCOME WAS ONLY NOTED AS THE PATIENT WAS DISCHARGED HOME. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Capsular Bag Tear; Vitrectomy; Vitreous Loss

  MAUDE report 8467969 ↗
• MalfunctionDec 31, 2018Scratched Material; Scratched Material

  IT WAS REPORTED THAT A ZCT150, 23.0 DIOPTER INTRAOCULAR LENS (IOL) WHEN BEING INSERTED INTO THE EYE OF THE PATIENT, A SCRATCH WAS NOTICED ON THE IOL. THE LENS WAS REMOVED AND REPLACED WITH THE BACK-UP LENS. PATIENT WAS FINE POST-OP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8207170 ↗
• InjuryJan 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT150 23.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018, BECAUSE THE PATIENT COMPLAINED OF BLURRED VISION AND RESIDUAL ASTIGMATISM. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED. THE REPLACEMENT LENS WAS A PCB00 22.0 DIOPTER LENS. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7231694 ↗
• InjuryNov 22, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (MODEL ZCT150, +23.0 DIOPTER) WAS IMPLANTED IN THE LEFT EYE OF A (B)(6) YEAR-OLD FEMALE PATIENT. REPORTEDLY, THE LENS WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE, BECAUSE THE PATIENT WAS NOT HAPPY WITH THE VISION. NO INCISION ENLARGEMENT AND NO VITRECTOMY WAS PERFORMED. REPORTEDLY, THE PATIENT DID NOT HAVE ANY CONTRIBUTING MEDICAL HISTORY. ANOTHER TORIC LENS, SAME MODEL SMALLER DIOPTER (+22.0) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT WAS REPORTED BEING HAPPY WITH HER VISION AFTER THE EXCHANGE. THE LENS WAS DISCARDED BY THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7054684 ↗
• MalfunctionNov 10, 2017Difficult or Delayed Positioning; Positioning Failure; Torn Material; Difficult or Delayed Positioning; Positioning Failure; Torn Material

  IT WAS REPORTED THAT A HAPTIC OF A ZCT150 23.0 DIOPTER INTRAOCULAR LENS (IOL) (HAPTIC) TORE WHILE INSERTING INTO THE PATIENT'S OPERATIVE EYE BECAUSE IT GOT STUCK TO THE PLUNGER. PART OF THE LEADING HAPTIC TOUCHED THE EYE, BUT THE LENS WAS NOT FULLY INSERTED. THE DOCTOR REMOVED THE DAMAGED LENS AND REPLACED IT WITH A BACK UP LENS, WHICH WAS THE SAME MODEL AND DIOPTER DURING THE SAME PROCEDURE. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED. REPORTEDLY, THE PATIENT IS FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7021631 ↗
• MalfunctionApr 7, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING HANDLING BUT PRIOR TO INSERTION, FOREIGN MATERIAL WAS NOTICED ON AN INTRAOCULAR LENS (IOL) UNDER A MICROSCOPE. REPORTEDLY, THE MATERIAL COULD NOT BE REMOVED. NO PATIENT CONTACT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 6472800 ↗
• InjuryFeb 3, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZCT150 23.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO AN UNEXPLAINED REFRACTIVE SURPRISE. LENS WAS REPLACED WITH THE SAME MODEL LENS, A SLIGHTLY LARGER, 24.5 DIOPTER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6301916 ↗
• MalfunctionJan 5, 2017Torn Material; Torn Material

  THE SURGEON NOTICED RESISTANCE UPON TWISTING THE PLUNGER, THE INTRAOCULAR LENS (IOL) BECAME MANGLED/TORN AS IT WAS ADVANCED INTO THE EYE AND WAS REMOVED. THE IOL WAS LOADED PER THE DIRECTIONS FOR USE. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6227821 ↗