TECNIS IOL ZCT300 (REF ZCT300U205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474553330), received between Dec 5, 2016 and Jun 9, 2021 — classified as 6 injuries, 3 malfunctions.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAPTIC DETACHED INSIDE THE PATIENT'S EYE. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS OF SAME MODEL (SN (B)(4)). HOWEVER, THERE WAS NO INJURY AND THERE WAS NO INTERVENTION THAT WAS REQUIRED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971626 ↗
• InjurySep 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT300 20.5 DIOPTER INTRAOCULAR LENS (IOL) WAS INSERTED AND THEN REMOVED BECAUSE THE PATIENT'S CHAMBER WAS WEAK AND WOULD NOT HOLD THE LENS. A VITRECTOMY WAS REQUIRED. VIA FOLLOW-UP THE CUSTOMER SAID THAT THERE DIDN'T APPEAR TO BE ANYTHING WRONG WITH THE LENS. THE PATIENT HAS A WEAK ANATOMY. A BACKUP IOL WAS USED TO COMPLETE THE PROCEDURE. THE CUSTOMER LATER FOLLOWED-UP TO PROVIDE MORE DETAILED INFORMATION. THE LENS WAS INJECTED INTO THE CAPSULAR BAG. IT WAS DIFFICULT TO KEEP THE BAG OPEN WHEN INSERTING THE LENS. ADDITIONAL VISCOELASTIC WAS INJECTED AROUND THE LENS. EVEN WITH THIS, THE LENS SEEMED TO DRAG ON THE CAPSULE. THE IOL WAS INSERTED AND VISCOELASTIC WAS IRRIGATED AND IT WAS VERY DIFFICULT TO REMOVE BEHIND THE LENS. THE ANTERIOR CHAMBER WAS INJECTED WITH BALANCED SALT SOLUTION AND WHEN ROTATING THE IOL IT WAS NOTED THAT THE POSTERIOR CAPSULE WAS OPENED. THE DECISION WAS MADE TO REMOVE THE TORIC IOL AS THERE WAS NOT ENOUGH CAPSULAR SUPPORT FOR THE LENS. ADDITIONAL VISCOELASTIC WAS USED TO DEEPEN THE CHAMBER. MICRO SCISSORS AND GRASPERS WERE USED TO HOLD AND CUT THE LENS. THE LENS WAS REMOVED WITHOUT PROBLEMS. AN ANTERIOR MECHANICAL VITRECTOMY WAS DONE

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 9137901 ↗
• InjuryAug 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT300 INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO UNEXPECTED POST-OP REFRACTION. AN INCISION ENLARGEMENT WAS PERFORMED BUT NO VITRECTOMY AND NO SUTURES. THE IOL WAS EXCHANGE FOR AN IOL OF A DIFFERENT MODEL AND DIOPTER. REQUESTS WERE MADE FOR ADDITIONAL INFORMATION BUT NO RESPONSE WAS RECEIVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8913569 ↗
• InjuryNov 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS TORIC INTRAOCULAR LENS (MODEL ZCT300, +20.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S OPERATIVE EYE BECAUSE OF PATIENT EXPERIENCING BLURRY AND DOUBLE VISION. THERE WAS NO VITRECTOMY, NO SUTURES AND NO INCISION ENLARGEMENT PERFORMED. REPORTEDLY LENS WITH MODEL AAB00, +18.5 DIOPTER WAS USED AS REPLACEMENT FOR THE PATIENT. PATIENT HAD NO ISSUES AND NO PROBLEMS POST OPERATIVELY. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8040638 ↗
• MalfunctionSep 28, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT MODEL ZCT300 TECNIS TORIC IOL (INTRAOCULAR LENS) WAS PLACED AT 90 DEGREES IN HER RIGHT EYE (OD) AND WAS MEASURED AT 103 DEGREES IN 6-MONTH STUDY VISIT. THERE IS NO IOL REPOSITIONING PLAN AT THIS TIME AS OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. FURTHERMORE, THERE WAS NO PATIENT INJURY. PRODUCT WILL NOT BE RETURNED AS IT REMAINS IMPLANTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7918732 ↗
• InjuryApr 6, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A TECNIS INTRAOCULAR LENS (MODEL ZCT300, +20.5 DIOPTER) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE IN A SECONDARY PROCEDURE. A LENS MODEL ZCT300, +18.5 DIOPTER WAS IMPLANTED AS A REPLACEMENT. NO INCISION ENLARGEMENT, NO VITRECTOMY WAS PERFORMED AND NO OTHER MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS REPORTED DOING GOOD WHEN DISCHARGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7402099 ↗
• InjuryMar 29, 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 FROM THE RIGHT EYE OF FEMALE PATIENT DUE TO RESIDUAL ASTIGMATISM. REPORTEDLY, THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY WAS PERFORMED, NO SUTURES WERE USED AND NO PATIENT POST-OP INJURY WAS REPORTED. A DIFFERENT TORIC LENS WAS IMPLANTED, ZCT150 +21,0 DIOPTER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6444309 ↗
• InjuryFeb 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO MECHANICAL FAILURE. FURTHER INFORMATION WAS PROVIDED AND STATED THAT MECHANICAL FAILURE REFERS TO HALOS/GLARE AND BLURRY VISION AND THAT IT IS UNKNOWN IF IT'S DUE TO THE LENS OR DUE TO A PATIENT ISSUE. A VITRECTOMY WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 6306010 ↗
• MalfunctionDec 5, 2016Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE OF A (B)(6) YEAR-OLD MALE PATIENT. THE LENS WAS PLACED AT 95 DEGREES AND IT WAS MEASURED AT 111 DEGREES AT THE SIX MONTH POST-OP VISIT, WITH A MISALIGNMENT OF 16 DEGREES. THE PATIENT WAS REPORTED COMPLAINING OF TIRED EYES, BUT THE VISUAL ACUITY WAS FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6145499 ↗