TECNIS IOL ZKB00 (REF ZKB00U0155)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05050474559998), received between Oct 5, 2016 and Jun 7, 2021 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Crack” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT THE PATIENT WAS COMPLAINING OF BLURRY VISION AT EVERY RANGE AND COULD NOT TOLERATE THE MULTIFOCAL INTRAOCULAR LENS (IOL). THE LENS WAS EXPLANTED FROM PATIENT'S RIGHT EYE AND REPLACED WITH A COMPETITOR'S LENS. THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTION WAS REQUIRED. THE PATIENT DOES NOT HAVE ANY ISSUES POST-OP. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 11949209 ↗
• InjuryDec 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 15.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. THE LENS REMAINS IMPLANTED, BUT AN AR40 MODEL LENS WITH 1.0 DIOPTER WAS IMPLANTED IN THE PATIENT'S LEFT EYE AS A PIGGYBACK. THERE WAS NO INCISION ENLARGEMENT AND NO VITRECTOMY. REPORTEDLY, THE PATIENT IS DOING OKAY. INTRAOCULAR LENS (IOL) MASTER RESULTS INDICATED THAT THE A CONSTANT USED WAS CORRECT (119.3 SRKT). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8136685 ↗
• InjurySep 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 15.5. DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT WAS UNABLE TO ADJUST TO THE LENS. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS A NON-JOHNSON AND JOHNSON LENS. REPORTEDLY, THE PATIENT S FINE NOW. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7846912 ↗
• InjuryJul 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 15.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE AND LATER EXPLANTED BECAUSE OF A REFRACTIVE CHANGE DUE TO A LASIK PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7725112 ↗
• InjuryJul 3, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE TECNIS MULTIFOCAL INTRAOCULAR LENS (MODEL ZKB00, +15.5 DIOPTER) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE IN A SECONDARY PROCEDURE BECAUSE OF A MECHANICAL COMPLICATION AND THE PATIENT NOT-ADAPTING TO THE LENS. DURING THE EXPLANT PROCEDURE, AN INCISION ENLARGEMENT WAS PERFORMED AND SUTURES WERE USED. A COMPETITOR LENS (+14.0 DIOPTER) WAS IMPLANTED AS A REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7658023 ↗
• InjuryNov 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (MODEL ZKB00, +15.5 DIOPTER) WAS IMPLANTED IN THE RIGHT EYE OF A (B)(6) YEAR-OLD MALE PATIENT ON (B)(6) 2017. REPORTEDLY, AT 6 WEEKS POST IMPLANTATION THE PATIENT WAS NOT ABLE TO SEE BETTER THAN 20/40 FOR DISTANCE AND NEAR VISION. IT WAS ALL BLUR. THE LENS WAS EXPLANTED ON (B)(6) 2017 AND REPLACED WITH A NON-AMO MONOFOCAL LENS (DIOPTER SIZE UNKNOWN). NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 6995262 ↗
• InjurySep 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 15.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017, DUE TO POOR VISION AND IT BEING A MISPOWERED LENS FOR THE PATIENT. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED. THERE WAS NO POST-OPERATIVE PATIENT INJURY. THE LENS WAS REPLACED WITH A ZLB00 17.0 DIOPTER IOL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 6877383 ↗
• MalfunctionJan 20, 2017Crack; Crack

  IT WAS REPORTED THAT DURING INSERTION INTO THE EYE, AN INTRAOCULAR LENS (IOL) WAS CRACKING AS IT WAS BEING ADVANCED IN THE CARTRIDGE. PATIENT CONTACT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6267534 ↗
• InjuryNov 8, 2016Adverse 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 THE PATIENT'S LEFT EYE AS THE PATIENT REPORTED THEY DID NOT HAVE NEAR VISION. AN INCISION ENLARGEMENT WAS REQUIRED AT EXPLANT. THERE WAS NO PATIENT INJURY REPORTED POST OP. THE LENS WAS REPLACED WITH A MODEL ZCB00, MONOFOCAL LENS, A LARGER DIOPTER SIZE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6088106 ↗
• InjuryOct 5, 2016Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE, AS LENS DISLOCATED. THERE WAS ALSO VITREOUS PROLAPSE (CAPSULE COLLAPSE) AND A VITRECTOMY PERFORMED AT EXPLANT OF THE LENS. NO INCISION ENLARGEMENT, SUTURES, OR PATIENT INJURY WAS REPORTED. THE DATE THE LENS DISLOCATED WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; No Code Available; Vitrectomy

  MAUDE report 5998971 ↗