TECNIS IOL ZCT300 (REF ZCT300U170)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474553262), received between Mar 3, 2017 and Jun 18, 2020 — classified as 6 injuries, 1 malfunction.

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

• InjuryJun 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE MODEL ZCT300 17.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S RIGHT EYE. THE IOL WAS EXPLANTED. THE CUSTOMER DID NOT PROVIDE ANY FURTHER INFORMATION.

  Patient problems: No Code Available

  MAUDE report 10166206 ↗
• InjuryJul 2, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT TECNIS TORIC INTRAOCULAR LENS (MODEL ZCT300 +17.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE BECAUSE OF ROTATION AND PATIENT DISSATISFACTION. A LENS FROM ANOTHER MANUFACTURER WAS USED AS REPLACEMENT FOR THE PATIENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8751750 ↗
• InjuryMay 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT'S LEFT EYE (OS) WAS PLANNED FOR EXPLANTED (B)(6) 2018. PER ACCOUNT, BOTH PATIENT'S EYES (OU) WERE IMPLANTED WITH ZCT 300 INTRAOCULAR LENSES. OS HAD POST-OP REFRACTIVE SURPRISE; +4.75 - 1.00 X 075 = 6/7 AND HIS RIGHT EYE (OD) WAS FINE WITH POST-OP REFRACTION; +0.50 - 1.00 -140 = 6/7. IT WAS NOTED THAT THE REASON FOR REFRACTIVE SURPRISE ON OS IS BECAUSE OF PROFOUND PSC, (POSTERIOR SUBCAPSULAR CATARACT), AND A NUCLEAR CATARACT. THESE FACTORS PREVENTED THE IOL MASTER MEASUREMENTS, NECESSITATED A-SCAN AND THUS GENERATED AN INACCURATE BIOMETRY. THE LENS FROM THE PATIENT¿S LEFT EYE IS PLANNED FOR EXPLANT TO REPLACE THE TORIC IOL. THE REPLACEMENT LENS WILL BE A DIFFERENT POWER INTRAOCULAR LENS. THE PATIENT'S OS WAS IMPLANTED (B)(6) 2018; THE RIGHT EYE WAS IMPLANTED, (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7532026 ↗
• InjuryNov 30, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A TECNIS TORIC INTRAOCULAR LENS (MODEL ZXT300, +17.0 DIOPTER) WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE ON (B)(6) 2017, FROM THE LEFT EYE OF A FEMALE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REVEALED THAT THE INCISION WAS ENLARGED TO REMOVE THE LENS. NO VITRECTOMY WAS PERFORMED, NO COMPLICATIONS AND NO OTHER MEDICAL OR SURGICAL INTERVENTION WAS REPORTED. IT WAS ALSO MENTIONED THAT THE IOL, IMPLANTED ON (B)(6) 017, WAS IN PATIENT'S EYE FOR A MONTH AND THE DOCTOR FELT THE POWER WAS NOT RIGHT SO THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER TORIC LENS, SAME MODEL SMALLER DIOPTER (+14.5). THE PATIENT WAS REPORTED DOING WELL WHEN DISCHARGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7073609 ↗
• InjuryOct 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR FOUND OUT THAT THE CAPSULAR BAG COLLAPSED AFTER IMPLANTING A ZCT300 17.0 DIOPTER INTRAOCULAR LENS (IOL) ON (B)(6) 2017. IT WAS THEN REMOVED AND REPLACED WITH A DIFFERENT KIND OF LENS. REPORTEDLY, THE DOCTOR PERFORMED A VITRECTOMY, BUT NO INCISION ENLARGEMENT OR SUTURES WERE REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 6933142 ↗
• MalfunctionSep 28, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT300 17.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) ON (B)(6) 2017. POST-OPERATIVELY, IT HAD ROTATED 24 DEGREES AT THE 6-MONTH DOCTOR VISIT. IT WAS REPORTED THAT NO REPOSITIONING OR FURTHER INTERVENTION IS REQUIRED. THERE WAS REPORTEDLY NO PATIENT COMPLICATION OR INJURY, INCLUDING ANY INTERFERENCE WITH ACTIVITIES IN DAILY LIFE. REPORTEDLY, PATIENT IS DOING WELL. THE PROTOCOL-DEFINED SLIT LAMP MEASUREMENT WAS 75 DEGREES ON (B)(6) 2017, VERSUS THE OPERATIVE PLACEMENT OF 99 DEGREES ON (B)(6) 2017. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6901592 ↗
• InjuryMar 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE BECAUSE OF UNEXPECTED VISUAL OUTCOME AND MECHANICAL COMPLICATIONS OF THE LENS. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS CLARIFIED THAT THE PATIENT HAD A LONG LEFT EYE AND THE SURGEON NEEDED A DIFFERENT KIND OF LENS FOR STABILIZATION. NO INCISION ENLARGEMENT, NO VITRECTOMY PERFORMED, NO SUTURES USED AND NO PATIENT INJURY WAS REPORTED. REPORTEDLY, A TORIC NON-AMO LENS WAS IMPLANTED AS REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6375378 ↗