TECNIS IOL ZCT225 (REF ZCT225U205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474552746), received between Jun 9, 2017 and Aug 4, 2020 — classified as 7 injuries.

The most frequently reported specific device problem is “Unintended Movement” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL)WAS IMPLANTED IN THE PATIENT'S LEFT EYE AND WAS SETTING AT 25 DEGREES AND SHOULD HAVE GONE IN AT 173 DEGREES. REFRACTION -1 =225 AT 143 DEGREES AND THAT GIVES THE PATIENT 20/20 VISION. THROUGH FOLLOW-UP, IT WAS LEARNED THE INCIDENT WAS FIRST OBSERVED THREE WEEKS POST-OPERATIVE. THE PATIENT NOTICED IMPAIRED VISION IN HIS LEFT EYE COMPARED TO HIS RIGHT EYE. THEREFORE, THE LENS WAS REPOSITIONED. THE SLIT LAMP SHOWED THE SURGEON 21 DEGREES, TO REPOSITION TO 163 DEGREES PER WEBSITE SUGGESTION. AFTER THE REPOSITION, FROM DAY ONE PATIENT STATED HIS VISION WAS BETTER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 10360616 ↗
• InjuryMay 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE FROM PATIENT'S RIGHT EYE DUE TO REFRACTIVE SURPRISE. THE REPLACEMENT LENS USED IS A MODEL ZCB00 WITH LOWER DIOPTER (21.0). PATIENT OUTCOME WAS REPORTED AS NO COMPLICATIONS. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Code Available

  MAUDE report 10031416 ↗
• InjuryJan 23, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT PATIENT¿S VISION HAS BEEN BAD SINCE SURGERY IN (B)(6) 2017, RECENTLY WAS TOLD BY HIS HEALTHCARE PROVIDER THAT HE HAS ASTIGMATISM IN HIS LEFT EYE WHEN HE THOUGHT IT SHOULD HAVE BEEN FIXED WITH THE SURGERY, HE CAN¿T GET EYE GLASSES BECAUSE HIS PRESCRIPTION KEEPS CHANGING AND IS NOT HAPPY WITH THE LENSES. REPORTEDLY HE WAS RECOMMENDED TO USE READING GLASSES. HE ASSUMES THAT HIS LENS MAY HAVE SHIFTED. PATIENT IS EXPERIENCING SCATTERED LIGHT, HALOS, STARBURSTS, DOUBLE VISION ESPECIALLY AT NIGHT. HE CAN SEE OF ABOUT 4 FEET AWAY, ANYTHING CLOSER IS BLURRY, HE CAN WATCH TELEVISION OK, HE CANNOT READ A BOOK, HE CAN USE HIS IPAD, BUT NEEDS TO ZOOM ALL THE WAY IN TO SEE IT. HE REALLY NEEDS GLASSES, BUT WITH HIS PRESCRIPTION CONSTANTLY CHANGING HE CAN¿T AFFORD TO BUY NEW GLASSES EVERY TIME. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT HIS ASTIGMATISM WAS NEVER RESOLVED, AND HIS DAILY ACTIVITIES ARE ISSUE AND HIS NIGHT VISION IS TERRIBLE. PATIENT THINKS THAT HIS LENS IN BOTH EYES HAS ROTATED DUE TO WHICH HE IS HAVING THIS ISSUE. PATIENT REPORTED THAT VISUAL ACUITY ISSUE WAS RIGHT AWAY AFTER THE SURGERY AND HAD BECOME WORSE AFTER THE LEFT EYE SURGERY. THIS EVE

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 9619862 ↗
• InjuryMar 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT225 20.5 DIOPTER INTRAOCULAR LENS (IOL) WAS INSERTED AND REMOVED FROM THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. THERE WAS NO PRODUCT QUALITY ISSUE, THE DOCTOR CHOOSE THE WRONG LENS. THERE WAS AN INCISION ENLARGEMENT, BUT NO VITRECTOMY AND NO SUTURES USED. THERE WAS NO PATIENT INJURY AND NO COMPLICATIONS POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7384415 ↗
• InjurySep 18, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (MODEL ZCT225, +20.5 DIOPTER) WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE FROM A (B)(6) MALE PATIENT BECAUSE OF AN HYPEROPIC OUTCOME AFTER THE FIRST SURGERY. REPORTEDLY, ANOTHER LENS, SAME MODEL HIGHER DIOPTER (+22.5) WAS IMPLANTED AS A REPLACEMENT WITHOUT COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6874007 ↗
• InjuryJun 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT225. 20.5 DIOPTER WAS EXPLANTED FROM A FEMALE PATIENT'S LEFT EYE DUE TO VARIED REFRACTIVE OUTCOME. ACCORDING TO THE PHYSICIAN, THE PATIENT EXPERIENCED VISUAL DISTURBANCE, ANISOMETROPIA AND PSEUDO PHAKIA. THE LENS WAS REPLACED WITH THE SAME MODEL LENS WITH A LOWER DIOPTER (19.0). THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES REQUIRED. NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6648725 ↗
• InjuryJun 9, 2017Break; Unintended Movement; Break; Unintended Movement

  IT WAS REPORTED THAT ORIGINALLY A RELOCATION OF THE LENS WAS SCHEDULED, BUT IT WAS FOUND THAT THE HAPTIC HAD A PIECE TORN OFF. THE LENS WAS THEN EXPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Code Available

  MAUDE report 6629044 ↗