TECNIS IOL ZCB00 (REF ZCB0000090)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474531499), received between Mar 29, 2017 and Dec 2, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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. 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.

• MalfunctionDec 2, 2024Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF MONOFOCAL NON-PRELOADED INTRAOCULAR LENS (IOL) WAS BROKEN AFTER IMPLANTATION. IOL WAS FULLY INSERTED INTO PATIENT'S EYE. THERE WAS NO INCISION ENLARGEMENT. NO VITRECTOMY WAS REQUIRED. DIRECTIONS FOR USE WERE FOLLOWED. AS PER ADDITIONAL INFORMATION RECEIVED, THE REMOVED IOL WAS REPLACED WITH SAME MODEL IOL. THERE WAS NO ANY PATIENT INJURY. PATIENT HAS RECOVERED. THE REMOVED IOL WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20828265 ↗
• MalfunctionSep 24, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO PATIENT'S OPERATIVE EYE; HOWEVER, LENS WAS REMOVED DURING THE SAME SURGERY DUE TO A MISSING HAPTIC. NO FURTHER COMPLICATIONS OCCURRED AND NO OTHER INTERVENTIONS WERE REQUIRED. ANOTHER LENS OF SAME MODEL WAS USED AS THE REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12530599 ↗
• MalfunctionApr 19, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE SURGEON THOUGHT THAT THERE WAS A SPECK ON THE INTRAOCULAR LENS (IOL) AFTER INJECTION INTO THE PATIENT'S EYE. REPORTEDLY, THE LENS WAS REMOVED AND REPLACED. NO INCISION ENLARGEMENT, NO SUTURE WAS USED AND NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7445911 ↗
• MalfunctionSep 26, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT'S EYE, A PIECE OF PLASTIC WAS NOTICED ON TOP OF THE LENS. REPORTEDLY, THE PLASTIC WAS REMOVED FROM THE EYE. THE ACCOUNT COMMENTED THAT THEY DON'T KNOW IF THE PLASTIC WAS COMING FROM THE LENS OR THE UNFOLDER (CARTRIDGE). ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE LENS WAS LEFT IN THE PATIENT'S EYE. NO INCISION ENLARGEMENT, NO VITRECTOMY WAS PERFORMED AND NO SUTURES WERE USED. THE PATIENT WAS REPORTED BEING FINE. THIS MDR IS TO RECORD THE LENS. A SEPARATE REPORT WILL BE FILED FOR THE CARTRIDGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6894752 ↗
• MalfunctionSep 1, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS STUCK IN THE CARTRIDGE AS IT WAS BEING INSERTED INTO THE EYE. THERE WAS PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Information

  MAUDE report 6839575 ↗
• MalfunctionMar 29, 2017Crack; Torn Material; Crack; Torn Material

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL), MODEL ZCB00, WAS CRACKED/TORN AND IT HAD A TORN HAPTIC. PATIENT CONTACT WAS REPORTED. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER ZCB00 LENS, DIOPTER SIZE NOT PROVIDED. NO INCISION ENLARGEMENT, NO SUTURE USED AND NO PATIENT INJURY WAS REPORTED. REPORTEDLY THE LENS WAS DISCARDED BY THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6444573 ↗