TECNIS IOL ZKB00 (REF ZKB00U0080)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474559844), received between Aug 20, 2018 and Dec 6, 2018 — 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.

• InjuryDec 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ZKB00 8.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) OF A FEMALE PATIENT ON (B)(6) 2017. REPORTEDLY, THE PATIENT HAD HYPEROPIC RESULTS AND AN AR40 MODEL LENS WITH +1.0 DIOPTER WAS IMPLANTED, IN A SEPARATE SURGICAL PROCEDURE, AS A PIGGYBACK TO CORRECT THE MISS. IT WAS STATED THAT THE PATIENT IS OK. THERE WAS NO WOUND ENLARGEMENT AND NO VITRECTOMY. THE ZKB00 LENS REMAINS IMPLANTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8136960 ↗
• InjuryOct 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS MULTIFOCAL INTRAOCULAR LENS (MODEL ZKB00, +8.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S LEFT EYE. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT LENS WAS EXPLANTED BECAUSE OF PATIENT EXPERIENCING BLURRY VISION. REPORTEDLY AN ANTERIOR VITRECTOMY WAS PERFORMED. PATIENT'S VISION WAS IN NORMAL LIMITS POST OPERATIVE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available; Vitrectomy

  MAUDE report 8026246 ↗
• InjuryAug 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD BEEN EXPERIENCING STARBURSTS AT NIGHT AND GLARE SENSITIVITY. THE ZKB00 +8.0 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM HER RIGHT EYE (OD) AND REPLACED WITH A MONOFOCAL AR40 +7.0 LENS. AN INCISION ENLARGEMENT WAS REQUIRED TO REMOVE THE LENS. PATIENT WAS DOING WELL POST-SURGERY. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7799499 ↗