TECNIS IOL ZMB00 (REF ZMB00U0190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474535602), received between Sep 2, 2016 and Feb 12, 2021 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Unfold or Unwrap” (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 18, 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.

• InjuryFeb 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT WAS IMPLANTED WITH A SYMFONY LENS IN THE RIGHT EYE (OD) ON (B)(6) 2020 WITH 20/25 DISTANCE AND J2 AT NEAR BUT THE PATIENT WAS NOT HAPPY WITH HIS READING VISION. THUS, THE DOCTOR DECIDED TO USE A ZMB00 MODEL FOR FELLOW (LEFT) EYE (OS). THE PATIENT UNDERWENT AN UNCOMPLICATED FLACS, PHACO, AND INTRAOCULAR LENS (IOL), MODEL ZMB00 WAS IMPLANTED IN LEFT EYE (OS) ON (B)(6) 2020. REPORTEDLY THE PATIENT BECAME HYPEROPIC +1.50 D, WITH 20/60 DISTANCE AND J2 AT NEAR WITH GLARE AND BLURRY VISION. BLURRY VISION AT DISTANCE AND NEAR POST-OP HYPEROPIC SURPRISE WAS REPORTED. THE PATIENT WAS REFRACTED ON (B)(6) 2021 WITH THE FOLLOWING RESULTS: OD: +0.50 SPHERE OD - 20/25. OS: +1.50-0.25 X 015 - 20/15 WITH MUCH SUBJECTIVE IMPROVEMENT AND LOSS OF THE HALOS. VISUAL ACUITY PRE-OPERATIVE: 20/40. VISUAL ACUITY POST-OPERATIVE: 20 . (B)(6) 2021 - SANS CORRECTION (SC) 20/60 SC J2 . REFRACTION OS: +150 - 0.25 X015 - 20/15. THE DOCTOR STATED THAT HE DID NOT UNDERSTAND THE HYPEROPIC SURPRISE IN THE LEFT EYE (OS) AS HE DID THE CORRECT MEASUREMENTS; AND THE 19.0 DIOPTER WAS SUPPOSED TO BE CORRECT FOR THE PATIENT, HOWEVER HE DECIDED TO EXPLANT THE LENS AND PUT IN A 21.5 DIOPTER

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 11320194 ↗
• InjuryMar 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZMB00 19.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2012. POST-OPERATIVELY, THE PATIENT COMPLAINED OF NOT BEING ABLE TO READ ANYMORE AND BLURRY VISION. REPORTEDLY, THERE IS NO PLAN TO EXPLANT THE LENS, BUT THE PATIENT WAS PRESCRIBED EYEGLASSES. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENSES IMPLANTED. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE PATIENT''S LEFT EYE. A SEPARATE REPORT WILL BE FILED FOR THE RIGHT EYE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 7351581 ↗
• MalfunctionFeb 26, 2018Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT WHILE INSERTING A TECNIS MULTIFOCAL INTRAOCULAR LENS (IOL) MODEL ZMB00 19.0 DIOPTER, INTO THE PATIENT¿S LEFT EYE, THE LENS FLIPPED SO THE PHYSICIAN CUT IT UP AND REMOVED IT. HOWEVER, IN FOLLOW UP IT WAS CLARIFIED THAT THE LENS DID NOT UNFOLD PROPERLY SO IT WAS REMOVED FROM THE EYE. ANOTHER TECNIS MULTIFOCAL INTRAOCULAR LENS MODEL ZMB00 OF A LOWER DIOPTER (18.5) WAS IMPLANTED AS THE REPLACEMENT LENS. THE PATIENT IS REPORTED TO BE DOING FINE POST-OP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7296441 ↗
• 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 6583580 ↗
• InjurySep 2, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT DEVELOPED TASS (TOXIC ANTERIOR SEGMENTS SYNDROME) POST IMPLANT OF A ZMB00 INTRAOCULAR LENS. ADDITIONAL INFORMATION WAS PROVIDED BY THE SURGICAL SITE AND IT WAS LEARNED THAT TWO WEEKS AFTER ONSET, TASS WAS STILL PRESENT. FURTHER FOLLOW UP CONFIRMED THE LENS IS STILL IMPLANTED AND THE ADVERSE EVENT WAS NOT RELATED TO THE LENS. THE PATIENT WAS PLACED ON DUREZOL EVERY HOUR IN THE OPERATED EYE.

  Patient problems: No Code Available

  MAUDE report 5926978 ↗