TECNIS IOL ZMB00 (REF ZMB00U0195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474535619), received between Sep 6, 2016 and May 22, 2017 — classified as 5 injuries.

The most frequently reported specific device problem is “Difficult to Insert” (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.

• InjuryMay 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT A MALE PATIENT IS EXTREMELY UNHAPPY HIS SURGERY RESULTS POST BILATERAL IMPLANTATION OF A ZMB00 LENS IN EACH EYE. PATIENT FEELS HIS VISION HAS BEEN RUINED. HE CAN SEE CRYSTAL CLEAR WITHIN 10-18 INCHES DISTANCE AND HAS GOOD VISION AT AROUND 10 FEET. THE PROBLEM IS HE HAS ¿GAPS¿ IN HIS VISION. HIS VISION IS BLURRY BETWEEN 18 INCHES ¿ 36 INCHES. HIS JOB REQUIRES HIM TO USE FOUR (4) COMPUTER MONITORS AT ONE TIME AND IT¿S VERY IMPORTANT HE CAN READ THOSE MONITORS. ADDITIONALLY, PATIENT IS ALSO EXPERIENCING HALOS AT NIGHT TIME/NIGHT VISION. THROUGH FOLLOW-UP IT WAS CLARIFIED THAT PATIENT CAN SEE CLEARLY FROM 7-14 INCHES, VISION IS BLURRY FROM 14-36 INCHES AND THEN VISION IS CLEAR AGAIN BEYOND 36 INCHES. DURING THE SURGERY ON THE LEFT EYE, HE COMPLAINED TO THE SURGEON THAT HE FELT PAIN DURING THE PROCEDURE AND THE SURGEON TOLD HIM SHE WAS ALMOST DONE. THERE IS CAPSULAR WRINKLING IN THE RIGHT EYE WHICH WILL BE TREATED WITH A LASER ON (B)(6) 2017. PATIENT DOES NOT HAVE ANY PAIN NOW, BUT AT THE END OF THE DAY HIS EYES FEEL TIRED AND HIS VISION IS BLURRY. THE LENS IN HIS LEFT EYE FEELS SMALL BUT THERE IS NO PAIN. HE ALSO COMPLAINED ABOUT BLURRY VISION AT THE 1-MONTH

  Patient problems: Blurred Vision; Halo; No Code Available; Visual Disturbances

  MAUDE report 6583572 ↗
• InjuryMar 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZMB00 19.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A MALE PATIENT'S RIGHT EYE DUE TO PATIENT EXPERIENCING BLURRY VISION AND MONOCULAR DIPLOPIA WHICH HAVE BEEN MONITORED BY THE PHYSICIAN FOR 1 YEAR UNTIL THE PATIENT COULD NOT DEAL WITH IT ANYMORE. THE PATIENT FELT UNSAFE WHEN WALKING OR DRIVING. THE LENS WAS REPLACED WITH A ZCB00 IOL. IT WAS REPORTED THAT THE PATIENT'S DIPLOPIA WAS RESOLVED AFTER EXPLANTATION.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 6438130 ↗
• InjuryNov 18, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZMB00 19.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO POOR READING AND POINT TOO CLOSE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6115337 ↗
• InjuryNov 15, 2016Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE INTRAOCULAR LENS, A MODEL ZMB00, 19.5 DIOPTER WAS EXPLANTED AND REPLACED WITH A LARGER DIOPTER LENS, A 20.5 DIOPTER, THE SAME MODEL LENS. THE REASON FOR THE EXPLANT WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6104829 ↗
• InjurySep 6, 2016Difficult to Insert; Difficult to Insert

  THE SURGEON HAD DIFFICULTY INSERTING THE INTRAOCULAR LENS (IOL) INTO THE PATIENT'S EYE AND HAD TO ENLARGE THE INCISION TO TAKE THE IOL OUT AND INSERT A NEW ONE. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Code Available

  MAUDE report 5931542 ↗