TECNIS IOL ZCB00 (REF ZCB0000265)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474531840), received between Aug 25, 2016 and Aug 30, 2022 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Sticking” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 30, 2022Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL), DESPITE BEING CORRECTLY POSITIONED, LOCKED THE CARTRIDGE, DAMAGING THE OPTICAL ZONE. IT OCCURRED DURING IMPLANTATION/APPLICATION. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15324605 ↗
• InjurySep 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCB00 26.5 DIOPTER LENS WAS INSERTED INTO THE CAPSULAR BAG WHEN SOMETHING HAPPENED TO THE BAG AND THE INTRAOCULAR LENS (IOL) WAS REMOVED. A VITRECTOMY WAS PERFORMED. THE LENS WAS REPLACED DURING THE SAME PROCEDURE WITH A DIFFERENT IOL, A SENSAR LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 9101431 ↗
• InjuryAug 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHEN CUSTOMER WAS ABOUT TO IMPLANT THE INTRAOCULAR LENS, THE CAPSULE STARTED TO COLLAPSE. THIS WAS OBSERVED WHILE INSERTING LENS INTO THE PATIENT'S LEFT EYE. REPORTEDLY ONLY THE TIP OF LENS WAS INSERTED AND THEN SURGEON REMOVED THE LENS IN THE SAME SURGICAL PROCEDURE. PATIENT HAS RECOVERED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 8853949 ↗
• MalfunctionJan 30, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT A ZCB00 26.5 DIOPTER INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE RIGHT EYE (OD) OF THE PATIENT ON (B)(6) 2018. THE LENS WAS REPLACED WITH THE SAME MODEL AND DIOPTER DUE TO LENS BEING RIPPLED. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7229574 ↗
• MalfunctionDec 1, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHAT WAS DESCRIBED AS GLUE WAS FOUND ON THE INTRAOCULAR LENS (IOL). THERE WAS NO PATIENT INVOLVEMENT/INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Patient Involvement

  MAUDE report 7073939 ↗
• InjurySep 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT A FEMALE PATIENT WAS SCHEDULED FOR AN IOL EXPLANT, MODEL ZCB00 (26.5 DIOPTER) ON THE RIGHT EYE (OD) DUE TO MYOPIC SURPRISE, THE PATIENT HAD DECREASED VISUAL ACUITY. IT WAS CONFIRMED THAT THE EXPLANT WAS PERFORMED ON (B)(6) 2017 AND THE REPLACEMENT LENS WAS THE SAME MODEL BUT A LOWER DIOPTER (24.5). IT WAS REPORTED THAT THE PATIENT WAS DOING WELL WHEN DISCHARGED. THERE WAS NO INCISION ENLARGEMENT REQUIRED, NO VITRECTOMY PERFORMED AND NO OTHER MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED. VISUAL ACUITY PRE-OP (PRE-INITIAL IMPLANT) 20/50, VISUAL ACUITY POST-OP (POST-INITIAL IMPLANT) 20/60, VISUAL ACUITY POST-OP (POST-REPLACEMENT) 20/25.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 6844182 ↗
• MalfunctionMar 10, 2017Sticking; Sticking

  IT WAS REPORTED THAT AFTER INSERTION INTO THE EYE OF AN INTRAOCULAR LENS (IOL), THE HAPTICS WERE STUCK TOGETHER ON THE OPTIC. NO PATIENT INJURY WAS REPORTED. REPORTEDLY THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6397508 ↗
• MalfunctionAug 25, 2016Sticking; Sticking

  IT WAS INITIALLY REPORTED THAT THE HAPTICS OF AN INTRAOCULAR LENS (IOL) WERE STICKING AFTER INSERTION INTO THE PATIENT'S EYE. NO PATIENT INJURY REPORTED AND THE LENS REMAINED IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE HAPTICS WERE STICKING ON THE LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5902771 ↗