TECNIS IOL ZCB00 (REF ZCB0000280)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474531871), received between Feb 26, 2018 and Sep 10, 2024 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE NON PRE-LOADED ZCB00 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). DUE TO COMPLAINTS OF REFRACTIVE SURPRISE, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A ZCB00 21.0 DIOPTER IOL. PATIENT SYMPTOMS PERSISTED FOR THREE (03) MONTHS. THE LENS EXCHANGE PROCEDURE DID NOT REQUIRE ANY SUTURES OR VITRECTOMY. BOTH NO AND UNKNOWN WERE PROVIDED AS ANSWERS FOR INCISION ENLARGEMENT. PATIENT PROGNOSIS POST-LENS EXCHANGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 20178599 ↗
• InjuryMay 15, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE SURGEON PULLED SOME PARTICLE OUT OF A PATIENT'S EYE FROM THE INJECTOR AFTER INJECTING IOL. ADDITIONAL INFORMATION REVEALED THAT WHEN IMPLANTING THE LENS, THERE WAS AN ADDITIONAL SHARP PIECE THAT CAME OUT WITH IT. IT ALMOST LOOKED LIKE THIS WAS A SHREDDED PIECE OF THE INTERNAL CARTRIDGE THAT GOT FORMED AS THE METAL PLUNGER WAS PUSHING THE LENS INTO THE EYE. IT HAPPENED AS IT INJECTED THE LENS INTO THE EYE. IT OCCURRED BECAUSE THE METAL PLUNGER MAY HAVE SCRAPED THE INTERNAL UNDERSIDE OF THE CARTRIDGE AND RIPPED A PIECE OFF, WHICH WAS SUBSEQUENTLY IMPLANTED IN THE EYE. THE IMPLANTED PIECE CREATED AN IRIS DEFECT DURING REMOVAL. THAT PATIENT IS CURRENTLY IMPLANTED WITH THAT IOL AND HAS SOME POSTOPERATIVE BLOOD, SOME GLARE, AND DISCOMFORT, BUT IS DOING OK. NO SURGICAL AND MEDICAL INTERVENTIONS ARE REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury; Eye Pain; Hyphema; Visual Disturbances

  MAUDE report 19317497 ↗
• MalfunctionDec 23, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE INNER PACKAGING THAT PROTECTS THE INTRAOCULAR LENS AND ENSURES ITS STERILITY HAD A HOLE IN THE BACK. THERE WAS NO PATIENT CONTACT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 11062406 ↗
• InjuryApr 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT STATUS POST HYPEROPIC LASIK IN THE RIGHT EYE WITH INTRAOCULAR LENS (IOL) IMPLANT. THROUGH FOLLOW-UP, IT WAS LEARNED THE SURGEON WAS TARGETING -2.50 FOR NEAR VISION AND THE POST-OP OUTCOME WAS AS EXPECTED. THE PATIENT REQUESTED FOR VISION TO BE CORRECTED FOR DISTANCE INSTEAD. THEREFORE, THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER ZCB00 LENS BUT LOWER DIOPTER (25.0). THERE WERE NO UNPLANNED SUTURES OR A VITRECTOMY REQUIRED AT LENS EXCHANGE. THE REPLACEMENT LENS WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9955921 ↗
• InjuryJun 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST IMPLANT OF THE INTRAOCULAR LENS (IOL) THE PATIENT WAS IMPACTED WITH DECREASED VISUAL ACUITY AND MYOPIC OUTCOME AFTER CATARACT SURGERY. THERE WAS A VITRECTOMY PERFORMED AND A SUTURE WAS PLACED. SUTURE WAS NOTED AS STANDARD PROCEDURE FOR THIS CASE. THERE WAS NO INCISION ENLARGEMENT REQUIRED. THE REPLACEMENT LENS WAS THE SAME MODEL BUT A LOWER DIOPTER. THE PATIENT WAS REPORTED TO BE DOING FINE WHEN DISCHARGED. VISUAL ACUITY PRE-OP (PRE-INITIAL IMPLANT): 20/40 (WITH GLASSES); VISUAL ACUITY POST-OP (POST-INITIAL IMPLANT):20/60; VISUAL ACUITY POST-OP (POST-REPLACEMENT):20/25+2. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Impairment; Vitrectomy

  MAUDE report 8694524 ↗
• InjuryAug 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR WAS TRYING OUT A SMALLER BLADE TO MAKE INCISION ENLARGEMENTS BEFORE CATARACT IMPLANTATION. THE DOCTOR INSERTED THE INSERTION SYSTEM, ENCOMPASSING A ZCB00 28.0 DIOPTER LENS, INTO THE ''SMALLER'' INCISION SITE AND AS THE LENS ADVANCED INTO THE PATIENT'S RIGHT EYE (OD), THE LEADING HAPTIC CAUGHT ON THE INCISION SITE. THEREFORE, THE INSERTION SYSTEM/LENS WAS REMOVED, THE INCISION SITE WAS ENLARGED, AND THEN REPLACED WITH A BACK UP LENS OF THE SAME MODEL AND DIOPTER. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7793043 ↗
• InjuryAug 9, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZCB00 28.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. IT WAS LATER EXPLANTED ON (B)(6) 2018, BECAUSE THE PATIENT WAS NOT HAPPY WITH LENS POWER. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 20.5. REPORTEDLY, THE PATIENT IS DOING GOOD POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7770986 ↗
• InjuryFeb 26, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS WAS EXPLANTED FROM THE PATIENT'S EYE BECAUSE THE INCORRECT DIOPTER SIZE WAS IMPLANTED. REPORTEDLY A ZCB00 +28.0 DIOPTER WAS IMPLANTED INSTEAD OF A ZCB00 +20.0 DIOPTER. APPARENTLY THE CARTON BOX STATED ZCB00 +20.0 BUT THE LENS INSIDE WAS A ZCB00 +28.0 INSTEAD. THEY DISCOVERED IT BECAUSE THE STICKERS IN THE PATIENT¿S CHART SHOWED IT WAS A ZCBOO +28.0. THE CARTON BOX WAS DISCARDED BY THE CUSTOMER. A ZCB00 +20.0 WAS THEN IMPLANTED AS A REPLACEMENT AND THE PATIENT WAS REPORTED BEING FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7298354 ↗