TECNIS IOL ZMB00 (REF ZMB00U0185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474535596), received between Nov 8, 2016 and Oct 18, 2022 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO A HYPEROPIC SURPRISE. THE PATIENT HAD A REFRACTIVE ERROR OF -3.50 AND FOGGY VISION, BEST CORRECTED VISION WAS 20/50. THE REPLACEMENT LENS WAS NOT PROVIDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 15621797 ↗
• InjuryNov 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SURGEON THAT THE PATIENT WILL BE UNDERGOING AN EXPLANT OF THE INTRAOCULAR LENS FROM A MODEL ZMB00 TO ZLB00 OF SAME DIOPTER. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9283790 ↗
• InjuryMar 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZMB00 18.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) 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 RIGHT EYE. A SEPARATE REPORT WILL BE FILED FOR THE LEFT EYE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 7351577 ↗
• InjuryOct 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZMB00 18.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE (OS) ON (B)(6) 2014. THE PATIENT COMPLAINED THAT IMMEDIATELY AFTER THE IMPLANTATION SHE HAD FLOATERS, BLURRINESS, AND HALOS. REPORTEDLY, THE PATIENT WENT BACK TO THE DOCTOR WHO THEN PERFORMED LASER IN BOTH HER EYES, WHICH RESOLVED THE FLOATERS. HOWEVER, THE BLURRINESS AND HALOS ARE STILL PRESENT. ALSO, THE PATIENT COMPLAINS THAT SHE CONSTANTLY MUST BLINK WHILE DRIVING JUST TO SEE AND DOES NOT DRIVE AT NIGHT ANY LONGER DUE TO THE HALOS. IN FOLLOW UP IT WAS LEARNED THAT THE PATIENT HAS BEEN GOING BACK AND FORTH TO DOCTOR FOR FOLLOW-UP BUT TO NO AVAIL. LAST FOLLOW-UP WAS WHEN THE DOCTOR DID LASER WHICH HELPED BUT ONLY WITH THE FLOATERS. THE BLURRINESS, HALOS/GLARES ARE STILL PRESENT. THE RIGHT EYE IS NOT AS BAD AS THE LEFT EYE BUT BOTH ARE EXPERIENCING THE SAME THING. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENSES IMPLANTED. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE PATIENT'S RIGHT EYE. A SEPARATE REPORT WILL BE FILED FOR THE LEFT EYE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 6950660 ↗
• InjuryOct 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZMB00 18.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE (OS) ON (B)(6)2014. THE PATIENT COMPLAINED THAT IMMEDIATELY AFTER THE IMPLANTATION SHE HAD FLOATERS, BLURRINESS, AND HALOS. REPORTEDLY, THE PATIENT WENT BACK TO THE DOCTOR WHO THEN PERFORMED LASER IN BOTH HER EYES, WHICH RESOLVED THE FLOATERS. HOWEVER, THE BLURRINESS AND HALOS ARE STILL PRESENT. ALSO, THE PATIENT COMPLAINS THAT SHE CONSTANTLY MUST BLINK WHILE DRIVING JUST TO SEE AND DOES NOT DRIVE AT NIGHT ANY LONGER DUE TO THE HALOS. IN FOLLOW UP IT WAS LEARNED THAT THE PATIENT HAS BEEN GOING BACK AND FORTH TO DOCTOR FOR FOLLOW-UP BUT TO NO AVAIL. LAST FOLLOW-UP WAS WHEN THE DOCTOR DID LASER WHICH HELPED BUT ONLY WITH THE FLOATERS. THE BLURRINESS, HALOS/GLARES ARE STILL PRESENT. THE RIGHT EYE IS NOT AS BAD AS THE LEFT EYE BUT BOTH ARE EXPERIENCING THE SAME THING. 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; Halo; Visual Disturbances

  MAUDE report 6950658 ↗
• InjuryMay 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE BECAUSE THE PATIENT WAS COMPLAINING OF HALOS AND GLARE. THE LENS WAS REPLACED WITH A NON-AMO LENS, MODEL AND DIOPTER UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THERE WAS NO PATIENT INJURY, NO CAPSULE TEAR AND NO VITRECTOMY WAS PERFORMED. THE INCISION HAD TO BE ENLARGED AND 3 OR 4 SUTURES WERE REQUIRED. THE PATIENT WAS REPORTED DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 6549781 ↗
• InjuryNov 8, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT PRESENTED WITH TOXIC ANTERIOR SEGMENT SYNDROME (TASS) AFTER IMPLANTATION OF A MODEL ZMB00 17.0 DIOPTER INTRAOCULAR LENS (IOL) INTO THE LEFT EYE. FIRST DAY POST-OP INFLAMED, REFERRED TO AN OPHTHALMIC SPECIALIST. THE IOL REMAINS IMPLANTED. VISUAL ACUITY IN THE LEFT EYE IS 20/40 UNCORRECTED AND 20/25-2 CORRECTED. THE PATIENT'S CURRENT STATUS IS INDICATED AS RECOVERED.

  Patient problems: Inflammation; No Code Available; Pain; Red Eye(s)

  MAUDE report 6088281 ↗