TECNIS IOL ZCB00 (REF ZCB0000110)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474531536), received between May 23, 2017 and Apr 7, 2021 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Scratched Material” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TECNIS MONOFOCAL INTRAOCULAR LENS (IOL) WAS REMOVED FROM THE PATIENT'S RIGHT (OD) EYE IN A SECONDARY PROCEDURE BECAUSE OF A MYOPIC SURPRISE. A REPLACEMENT LENS IS THE SAME MODEL AT A LOWER DIOPTER (8.5). THERE WAS NO ADDITIONAL INTERVENTION. REPORTEDLY, THE PATIENT IS DOING FINE POST-EXCHANGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 11626088 ↗
• InjuryApr 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT EYE DUE TO REFRACTIVE SURPRISE AND IOL POWER. ADDITIONAL INFORMATION STATES THERE WAS NO INCISION ENLARGEMENT, SUTURE OR VITRECTOMY PERFORMED. THE REPLACEMENT LENS IS A TECNIS MODEL 14.0 DIOPTER. PATIENT IS DOING FINE POST-OP. THE EXPLANTED LENS IS NOT AVAILABLE FOR RETURN. VISUAL ACUITY PRE-OP (PRE-INITIAL IMPLANT): 20/100, VISUAL ACUITY POST-OP (POST-INITIAL IMPLANT) 20/100, VISUAL ACUITY POST-OP (POST-REPLACEMENT): 20/25+. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9951885 ↗
• MalfunctionDec 29, 2017Scratched Material; Scratched Material

  THE DOCTOR FOUND A SCRATCH NEAR THE OPTIC OF THE INTRAOCULAR LENS (IOL). THERE WAS NO PATIENT INVOLVEMENT OR INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Patient Involvement

  MAUDE report 7153740 ↗
• InjuryJul 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS IMPLANTED AND REMOVED DURING THE INITIAL PROCEDURE DUE TO THE CAPSULE NOT INTACT ENOUGH TO HOLD THE LENS. THE PATIENT REQUIRED A VITRECTOMY FOLLOWING THE LENS REMOVAL. THE VITRECTOMY WAS DUE TO PATIENT ANATOMY. AN INCISION ENLARGEMENT WAS REQUIRED. THEN LENS WAS CUT IN HALF AND DISCARDED. THE DOCTOR ATTEMPTED A NEW LENS IMPLANT, WITH AN ANTERIOR CHAMBER LENS; MODEL AND TYPE UNKNOWN, HOWEVER THIS WAS UNSUCCESSFUL. THE PATIENT WENT HOME APHAKIC FOLLOWING THIS ATTEMPTED IMPLANT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 6736479 ↗
• InjuryMay 23, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE BECAUSE OF A DEFECT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6585672 ↗