TECNIS IOL ZKB00 (REF ZKB00U0105)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474559899), received between Sep 14, 2016 and May 31, 2019 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 10.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO UNEXPECTED POST-OP REFRACTION. A REPLACEMENT LENS WAS A NON-JOHNSON AND JOHNSON LENS. THERE IS NO INCISION ENLARGEMENT OR SUTURE USED. REPORTEDLY, PATIENT IS DOING FINE POST-SURGERY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8660537 ↗
• InjurySep 14, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT HAD A TECNIS 1 MULTIFOCAL (TMF) INTRAOCULAR LENS (IOL) PLACED IN HIS EYE AND HE DID NOT HAVE GOOD VISION. THE PATIENT DID NOT SHARE THE EXACT DATE OF THE SURGERY. THE PATIENT HAS VISITED A RETINAL SPECIALIST AND THEY STATED THERE WAS NOTHING WRONG WITH HIS EYE BUT HE NEEDED AN EXPLANT OF THE LENS. THE PATIENT WAS ABLE TO FIND A DOCTOR IN HIS AREA THAT HAS EXPERIENCE WITH THE TMF IOLS AND HAS AN APPOINTMENT SCHEDULED TO DETERMINE POSSIBLE OPTIONS WITH IMPLANTED LENSES AND IF AN EXPLANT IS REQUIRED DUE TO GLARE ESPECIALLY IN HIS LEFT (OS) EYE WITH IMPLANT: ZLB00. THE PATIENT ALSO HAS A ZKB00 IN HIS RIGHT (OD) EYE. THROUGH FOLLOW UPS, THE PATIENT CONFIRMED THAT HE IS FRUSTRATED WITH THE TWO LENSES IMPLANTED IN HIS EYES LAST YEAR. HIS SYMPTOMS OF GLARE AND NOT HAVING GOOD VISION OVERALL IS BOTHERING HIM TOO MUCH. HOWEVER, HE IS ABLE TO DRIVE, READ BUT HE IS ANNOYED WITH THE GLARES AND POOR OVERALL VISION. THE PATIENT HAS BEEN TO SEVERAL DOCTORS AND NEXT WEEK HE HAS AN APPOINTMENT WITH ONE MORE DOCTOR. HIS DOCTORS ARE SUGGESTING EXPLANT HOWEVER, THE PATIENT IS HESITANT. THE PATIENT STATED HE KNOWS THAT THERE ARE RISKS AND HE IS ANXIOUS AS THEY MAY BE

  Patient problems: Halo; Visual Disturbances

  MAUDE report 5951522 ↗