TECNIS IOL ZCB00 (REF ZCB0000050)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474534612), received between Oct 18, 2018 and Nov 19, 2020 — classified as 4 injuries, 2 malfunctions.

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.

• MalfunctionNov 19, 2020Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  AFTER INSERTING AN INTRAOCULAR LENS (IOL) IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE), IT WAS REPORTED THERE WAS A FOLDING ISSUE; LENS WAS INSERTED BUT WAS NOT LEFT IMPLANTED. THE LENS WAS REMOVED WITHOUT INCISION ENLARGEMENT. OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE, IT WAS REPORTED THE PATIENT HAS RECOVERED. THE LENS WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10870192 ↗
• InjuryMar 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (MODEL ZCB00 5.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE (OD) IN SECONDARY SURGICAL PROCEDURE AS THE PATIENT WANTED SOMETHING DIFFERENT. LENS FROM ANOTHER MANUFACTURER WAS USED AS THE REPLACEMENT LENS. NO SURGICAL AND/OR MEDICAL INTERVENTIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES WERE REPORTED. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9879911 ↗
• InjuryDec 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S EYE. REASON FOR EXPLANT IS UNKNOWN/NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9468443 ↗
• InjuryOct 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZCB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE. REPORTEDLY, THE DOCTOR INITIALLY IMPLANTED A NON-JOHNSON AND JOHNSON IOL. PATIENT THEN HAD AN UNEXPECTED POST-OP REFRACTIVE OUTCOME. HE DID AN IOL EXCHANGE AND REPLACED THE NON-JOHNSON AND JOHNSON IOL WITH A ZCB00 LENS. AFTER THE EXCHANGE HOWEVER, THE PATIENT ONCE AGAIN HAD AN UNEXPECTED POST-OP REFRACTIVE OUTCOME (-4.5). THE DOCTOR WANTS TO DO ANOTHER EXCHANGE IN THIS EYE. FURTHER FOLLOW-UP CONFIRMED THAT THE SUSPECT ZCB00 WAS EXPLANTED AND REPLACED WITH AN AR40M IOL. THE PATIENT REFRACTED TO +3.50. IT WAS LEARNT THAT THE DOCTOR IS EXTREMELY FRUSTRATED AND NOT SURE WHAT TO DO NEXT. HE WILL MOST LIKELY REFER THE PATIENT TO ANOTHER SURGEON. PRODUCT WAS NOT KEPT FOR RETURN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9206289 ↗
• InjuryAug 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A MODEL ZCB00 INTRAOCULAR LENS WAS INSERTED THE PATIENT¿S CAPSULE TORE. THE LENS WAS REMOVED FROM THE EYE AND WAS NOT REPLACED. THE PATIENT LEFT WITHOUT A LENS. THE ACCOUNT DOESN'T BELIEVE A VITRECTOMY WAS REQUIRED AND THERE IS NO OTHER MEDICAL INTERVENTION NOTED. THE CUSTOMER BELIEVES THE PATIENT IS FINE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Capsular Bag Tear; No Code Available

  MAUDE report 8938619 ↗
• MalfunctionOct 18, 2018Break; Break

  IT WAS REPORTED THAT A TECNIS MONOFOCAL INTRAOCULAR LENS (MODEL ZCB00 +5.0 DIOPTER) HAD BROKEN HAPTIC. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7982727 ↗