TECNIS IOL ZCB00 (REF ZCB0000315)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474531949), received between Jan 31, 2019 and Feb 10, 2021 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS 1-PIECE INTRAOCULAR LENS (IOL) WAS DISPLACED BECAUSE OF THE PATIENT'S CAPSULAR BAG WAS COMPROMISED. THE LENS WAS EXPLANTED AND VITRECTOMY WAS PERFORMED. THE REPLACEMENT LENS IS AN ANTERIOR LENS, ZA9003 28.5 DIOPTER. PATIENT OUTCOME IS NOT PROVIDED AND THE LENS WAS DISCARDED. NO ADDITIONAL INFORMATION PROVIDED.

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

  MAUDE report 11309429 ↗
• InjuryOct 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED POST IMPLANT OF LENS MODEL ZCB00 31.5 DIOPTER INTRAOCULAR LENS (IOL), THE PATIENT POST-OP RESULTS WERE -6.0 DIOPTER, TARGET WAS -2.0 DIOPTER. BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) WAS 1.0 -8.0 DIOPTER. THE SURGEON DECIDED TO EXPLANT THE LENS REQUIRING INCISION ENLARGEMENT, AND THE LENS IS IN TWO PIECES. THE EXPLANTED LENS WAS REPLACED WITH A NEW LENS, 31.0 DIOPTER. POST-EXCHANGE THE NEXT MORNING, THE PATIENT¿S BCDVA WAS 0.5 -2.00 DIOPTER, TARGET WAS -2.0 DIOPTER, AND VISUAL ACUITY (VA) 1.0. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9177355 ↗
• InjuryJan 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCB00 31.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2019 BECAUSE THE PATIENT COMPLAINED ABOUT HAVING TO HOLD ITEMS TOO CLOSE TO SEE THEM. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER. REPORTEDLY, THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8295198 ↗