TECNIS IOL ZMB00 (REF ZMB00U0200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474535626), received between Dec 21, 2016 and Feb 13, 2019 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT REPORTED THAT SHE WAS IMPLANTED WITH A MODEL ZMB00 INTRAOCULAR LENS (IOL) IN EACH EYE. SHE WANTED TO KNOW IF WE HAD ANY REPORTS OF LENSES LOSING POTENCY AFTER A FEW YEARS. THE LENSES WERE IMPLANTED ABOUT 4 YEARS AGO, HER EYES HAVE BEEN RED AND SWOLLEN ADDITIONALLY, SHE CANNOT SEE AS WELL AS SHE USED TO. SHE HAS SEEN HER DOCTOR ABOUT THESE ISSUES. THROUGH FOLLOW-UP WITH THE PATIENT, IT WAS LEARNED HER VISION WAS OKAY UNTIL ABOUT 6 MONTHS WHEN HER VISUAL ISSUES OF NOT SEEING WELL STARTED. RECENTLY, SOMETHING IS WRONG WITH HER RETINA (SHE REPORTS SHE HEARD WRINKLE IN RETINA) AND SHE IS SEEING A RETINA SPECIALIST. FOLLOW-UP WITH THE PHYSICIAN¿S OFFICE CONFIRMED THAT THE PATIENT WAS JUST IN THE CLINIC A FEW DAYS AGO FOR FOLLOW-UP. THE CONTACT PERSON PROVIDED PRODUCT IDENTIFIERS AS WELL AS IMPLANT DATES FOR EACH IOL. SHE ADDED THAT IN THE PATIENT¿S CHART, IT IS NOTED THE PATIENT HAS GLAUCOMA, MACULAR PUCKER, DRY EYE, AND IS SEEING A RETINA SPECIALIST. THE CHART ALSO INDICATED THAT IN (B)(6) 2014, THE PATIENT'S BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/20 BOTH EYES (OU) BUT THEN IN HER RECENT VISIT HER BCVA WAS 20/50 FOR THE LEFT EYE (OS) AND 20/30 FOR THE RIGHT (OD). TH

  Patient problems: Dry Eye(s); Inflammation; Visual Impairment

  MAUDE report 8337461 ↗
• InjuryNov 28, 2018Device Dislodged or Dislocated; Unintended Movement; Device Dislodged or Dislocated; Unintended Movement

  IT WAS REPORTED THAT THE LENS WAS IMPLANTED IN PATIENT¿S RIGHT EYE THAT HAD CAPSULAR TEAR. LENS DISLOCATED POST OPERATIVELY AND WAS NOTICED ON DAY 54 POST IMPLANTATION. THE LENS WAS PLANNED TO BE EXPLANTED IN SECONDARY SURGERY BECAUSE OF PATIENT EXPERIENCING CLOUDY VISION, DOUBLE VISION AND DECREASED VISUAL ACUITY. REPORTEDLY THE LENS WAS SCHEDULED TO BE EXPLANTED ON (B)(6) 2018. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT SURGERY WAS ABORTED DUE TO UNSTABLE CAPSULE. ONE 10-0 SUTURE WAS USED ON THE PRIMARY INCISION WHICH WAS NOT ENLARGED. PATIENT WAS DOING FINE. THE LENS IS STILL IMPLANTED. VISUAL ACUITY PRE-OP - 20/400 BCVA (BEST CORRECTIVE VISUAL ACUITY). VISUAL ACUITY POST-OP - 20/100, PINHOLE 20/60. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8109533 ↗
• InjuryFeb 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS MULTIFOCAL INTRAOCULAR LENS (MODEL ZMB00 +20.0 DIOPTER) WAS EXPLANTED IN A SECONDARY PROCEDURE BECAUSE OF PATIENT COMPLAINED OF BLURRY VISION, HALOS, AND TROUBLE SEEING DISTANCE AND NEAR. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT VITRECTOMY WAS PERFORMED DURING THE EXPLANT AND TECNIS MONOFOCAL INTRAOCULAR LENS (MODEL Z9002 +19.0 DIOPTER) WAS IMPLANTED AS THE REPLACEMENT LENS FOR THE PATIENT. ALSO NOTED WAS THE PATIENT UNDERWENT A YAG (YTTRIUM-ALUMINUM-GARNET) PROCEDURE PRIOR TO EXPLANT. PATIENT WAS DOING FINE BUT HAD BLURRY VISION AT DISCHARGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Impairment

  MAUDE report 7281531 ↗
• InjuryFeb 16, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZMB00 20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. ON POST OP DAY 1, THE PATIENT WAS UNHAPPY WITH THE LENS. THE LENS WAS LATER EXPLANTED ON (B)(6) 2018. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT, LARGER DIOPTER OF 22.0. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7279202 ↗
• InjurySep 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) YEAR-OLD MALE PATIENT REPORTED THAT HE HAD A BILATERAL INTRAOCULAR LENS IMPLANTS ON (B)(6) 2016. SINCE THE SURGERY THE PATIENT HAS EXPERIENCED DOUBLE VISION WITH HIS LEFT EYE (ZLB00 LENS IMPLANTED) AND HALOS WITH HIS RIGHT EYE (ZMB00 LENS IMPLANTED). THE PATIENT ALSO SUFFERS OF ASTIGMATISM. REPORTEDLY, THE SURGEON GAVE THE PATIENT EYE DROPS BUT THEY DIDN'T HELP. THE LENSES REMAIN IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED AND THE SURGEON COMMENTED THAT THE PATIENT NEEDS EYE DROPS. THE PATIENT SUFFERED OF METAMORPHOPSIA OF SECOND DEGREE MER IN THE LEFT EYE, BUT NO SURGERY WAS PERFORMED FOR THE MER. REPORTEDLY, THIS DOES NOT AFFECT THE PATIENT'S DAILY ACTIVITIES, BUT THE SURGEON STATED THAT A MEDICAL/SURGICAL INTERVENTION FOR THE MER IN THE LEFT EYE IS POSSIBLE. VISUAL ACUITY PRE-OP: RIGHT EYE ¿ 20/30; LEFT EYE -20/40, VISUAL ACUITY POST-OP: RIGHT EYE ¿ 20/20; LEFT EYE ¿ 20/25. THIS MDR IS TO RECORD THE ZMB00 LENS IMPLANTED IN THE RIGHT EYE. A SEPARATE REPORT WILL BE FILED FOR THE ZLB00 LENS IMPLANTED IN THE LEFT EYE.

  Patient problems: Halo; No Code Available

  MAUDE report 6892940 ↗
• InjuryMay 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL ZMB00 +20.0 DIOPTERS, WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE BECAUSE OF COMPLICATIONS OF THE IOL AND VISUAL DISTURBANCES. A NON-AMO LENS, +21.0 DIOPTERS, WAS IMPLANTED AS THE REPLACEMENT. REPORTEDLY, THE INCISION WAS NOT ENLARGED TO REMOVE THE LENS, A VITRECTOMY WAS NOT PERFORMED, AND SUTURES WERE NOT USED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6574306 ↗
• InjuryDec 21, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTATION OF A ZMB00 20.0 DIOPTER INTRAOCULAR LENS(IOL), THE PATIENT EXPERIENCED A REFRACTIVE SURPRISE, HALOS/GLARE ISSUES THAT HAS AFFECTED THE PATIENT'S DAILY ACTIVITIES. LENS WAS EXPLANTED (B)(6) 2016 AND REPLACED WITH A ZCB00 20.0 DIOPTER IOL. THERE WERE NO INCISION ENLARGEMENT, VITRECTOMY OR LENS ROTATION PERFORMED. PATIENT IS NOW HAPPY WITH HIS VISION AFTER THE LENS REPLACEMENT. PATIENT'S VISUAL ACUITY: VISUAL ACUITY PRE-OP (PRE-INITIAL IMPLANT): 20/30-1. VISUAL ACUITY POST-OP (POST-INITIAL IMPLANT): 20/25-2. VISUAL ACUITY POST-OP (POST-REPLACEMENT): 20/20. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 6197316 ↗