TECNIS IOL ZCB00 (REF ZCB0000300)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474531918), received between Feb 21, 2017 and Oct 27, 2023 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS SCRATCHED AND COULDN'T BE USED. ADDITIONAL INFORMATION RECEIVED STATED THAT THE SCRATCH WAS NOTICED DURING IMPLANTATION OF IOL IN THE PATIENTS RIGHT EYE. THE LENS WAS PARTIALLY INSERTED AND REMOVED AS DOCTOR SAW SCRATCH AND DID NOT WANT TO TAKE CHANCE OF IT BEING SCRATCHED AND NOT WORK IN PATIENT EYE. THERE WAS NO PATIENT INJURY AND NO OTHER MEDICAL OR SURGICAL INTERVENTION REQUIRED. THERE WAS NO USE ERROR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER BACK UP IOL OF SAME MODEL AND DIOPTER. THE LENS WAS DESTROYED AND NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18022618 ↗
• InjuryOct 3, 2023Difficult to Fold, Unfold or Collapse; Adverse Event Without Identified Device or Use Problem; Difficult to Fold, Unfold or Collapse; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT NON-PRELOADED MONOCULAR INTRAOCULAR LENS (IOL) WITH MODEL ZCB00 DISPLACED INFERIONASALLY. SURGEON HAD TO CUT OUT AND USE BACKUP LENS WITH MODEL ZA9003 IN SAME SURGICAL PROCEDURE. SUTURES WERE REQUIRED, AFTER A NEW LENS, THE PATIENT RECOVERED WITHOUT ISSUE. ADDITIONAL INFORMATION REVEALED THAT THE SURGERY PROCEEDED NORMALLY WITH LENS REMOVAL. THE CAPSULAR BAG WAS RE-INFLATED WITH VISCOELASTIC AND THE CAPSULAR BAG WAS INTACT. THE ZCB00 LENS WAS PLACED IN THE EYE USING A SHOOTER AND ALLOWED TO UNFOLD IN THE CAPSULAR BAG. THE INSERTER WAS NOT ADVANCED INTO THE ANTERIOR CHAMBER. A KUGLEN HOOK WAS USED TO PUSH THE TRAILING HAPTIC FROM THE ANTERIOR CHAMBER INTO THE CAPSULAR BAG, AND A TEAR IN THE POSTERIOR CAPSULE WAS SEEN WITH THE LEADING HAPTIC GOING THROUGH THE TEAR. IOL WAS BROUGHT BACK INTO THE ANTERIOR CHAMBER AND REMOVED FROM THE EYE BY CUTTING EACH LENS INTO THREE PIECES AND REPLACING THEM WITH A THREE-PIECE SULCUS LENS. PATIENT HAS BEEN REFERRED TO A RETINA SPECIALIST FOR EVALUATION BECAUSE THE SULCUS IOL DISLOCATED. APPOINTMENT IS SCHEDULED FOR 9/14/2023.NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear

  MAUDE report 17864964 ↗
• InjuryAug 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCB00 30.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT EXPERIENCED ANISOMETROPIA. THERE WAS NO INCISION ENLARGEMENT AND THERE WAS NO PATIENT INJURY. THE REPLACEMENT LENS WAS ANOTHER ZCB00 MODEL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7823042 ↗
• InjuryAug 17, 2018Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAPTIC WAS NEARLY BROKEN FROM THE OPTIC. AS A RESULT, LENS WAS REMOVED AND REPLACED WITH AN INCISION ENLARGEMENT. SURGERY WAS SUCCESSFULLY COMPLETED USING THE BACK-UP LENS, SAME MODEL AND DIOPTER. PATIENT WAS DISCHARGED WITH NO COMPLICATIONS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7793659 ↗
• InjurySep 5, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED AS THE PATIENT WAS NOT SATISFIED WITH HIS/HER FAR VISION. THE IOL WAS REPLACED WITH AN IOL OF THE SAME MODEL BUT DIFFERENT DIOPTER. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Code Available

  MAUDE report 6843612 ↗
• InjuryFeb 21, 2017Difficult To Position; Difficult To Position

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WOULD NOT POSITION CORRECTLY IN THE EYE. REPORTEDLY THE LENS WAS CUT OUT OF THE EYE. AN UNDEFINED PATIENT INTERVENTION/INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Injury; No Code Available; No Consequences Or Impact To Patient

  MAUDE report 6347814 ↗