TECNIS IOL ZMB00 (REF ZMB00U0210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474535640), received between Sep 30, 2016 and Apr 24, 2024 — classified as 5 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 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.

• InjuryApr 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DOCTOR REFERRED A FEMALE PATIENT TO ANOTHER DOCTOR TO SEE ABOUT AN YTTRIUM-ALUMINUM-GARNET (YAG) LASER TREATMENT. IT WAS REPORTED THAT THE PATIENT DOES HAVE A TINY BIT OF POSTERIOR CAPSULAR OPACIFICATION (PCO) IN THE RIGHT EYE (OD). THAT THE PATIENT STATED SHE COULD NOT READ ANYTHING IF IT IS LAYING ON HER DESK AND SHE IS LOOKING DOWN AT IT. THAT THE PATIENT HAS TO HOLD IT UP DIRECTLY IN FRONT OF HER TO READ. THE PATIENT REPORTED TO HER DOCTOR THAT WHEN SHE WEARS HER PERSONAL SUNGLASSES, NON-PRESCRIPTION (NON-RX), SHE SEES A "MAZE" ON THE INSIDE OF THE LENSES WITH EACH EYE. THE PATIENT DID NOT SAY SHE SEES RINGS, SHE SAID A MAZE WHICH THE DOCTOR HAD NO IDEA WHAT THAT WOULD BE ABOUT. ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT INDICATED THAT EVER SINCE HER CATARACT SURGERIES, THE PATIENT HAS NOT BEEN ABLE TO SEE AND HAS DISCOMFORT. THE PATIENT REPORTED THAT EVERYTHING IS BLURRY, HAS TO LOOK A LITTLE FROM THE SIDE, TILT IN VARIOUS DIRECTIONS, FEELS LIKE HER EYEBALLS & EVERYTHING AROUND THEM ARE SWOLLEN & HAS A FRAME AROUND THEM. THE PATIENT HAS PAIN DAILY IN HER EYES NO MATTER HOW MANY DROPS SHE USES, SHE EXPERIENCES PRESSURE AND FEELING OF A FRAME/RESTRICTION AROUND HER EYE,

  Patient problems: Blurred Vision; Eye Pain; Halo; Posterior Capsule Opacification; Visual Disturbances; Visual Impairment

  MAUDE report 19177912 ↗
• InjuryAug 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OCULAR SINISTER (LEFT EYE). PATIENT REPORTS COMPLAINTS OF DOUBLE VISION STARTING APPROXIMATELY 2 TO 3 YEARS AGO BUT DID NOT HAVE THE ISSUES CHECKED EARLIER BY A DOCTOR DUE TO THE COVID PANDEMIC. WHEN ASKED IF SYMPTOMS ARE DEBILITATING, PATIENT STATED CAN'T READ THE PAPER, CAN'T TAKE WALKS, AND CAN'T DRIVE AS IT IS NOT SAFE. DOUBLE VISION OCCURS WHEN BOTH EYES ARE OPEN. IF HE CLOSES EITHER EYE THE DOUBLE VISION GOES AWAY. PATIENT DOES NOT HAVE DIABETES BUT TAKES ATENOLOL TO REGULATE HIGH BLOOD PRESSURE. HE IS SCHEDULED TO SEE A SPECIALIST IN EARLY SEPTEMBER. PATIENT WAS INFORMED THAT THE IOL MODEL AND SERIAL NUMBER HE HAS IMPLANTED WAS NOT INVOLVED IN A PRODUCT RECALL. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 12368214 ↗
• InjuryApr 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZMB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT''S RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE BECAUSE OF DYSPHOTOPSIA. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES REQUIRED. THE REPLACEMENT LENS USED IS A MODEL ZCB00 BUT SAME DIOPTER LENS. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 10002740 ↗
• InjuryOct 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZMB00 21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6927525 ↗
• InjurySep 30, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED THAT SHE RECEIVED BILATERAL TECNIS MULTIFOCAL LENS IMPLANTS WITH HER CATARACT SURGERY. HER VISION IS NOW CLOUDY AND VERY BLURRY AND IT IS VERY DIFFICULT TO READ PRINT AND COMPUTER SCREENS; THERE IS ALWAYS GLARE. PATIENT NOTED SHE HAD LASIK SURGERY IN THE PAST. ADDITIONAL INFORMATION WAS OBTAINED FROM THE SURGERY CENTER. AT THE PATIENT'S LAST FOLLOW-UP, THE PATIENT'S UNCORRECTED VISUAL ACUITY (UCVA) FOR BOTH EYES WAS 20/40. THE DOCTOR'S DIAGNOSIS IS POSTERIOR CAPSULE FIBROSIS AND HE IS THINKING THAT THIS MAY BE THE CONTRIBUTING FACTOR TO THE PATIENT'S BLURRY VISION, DRYNESS AND OTHER VISUAL ISSUES. TREATMENT GIVEN WAS MEDICATION FOR DRYNESS. DOCTOR GAVE PATIENT MEDICAL TREATMENT FOR DRYNESS. DOCTOR ALSO INDICATED IN THE CHART THAT THERE'S NOTHING IN QUESTION WITH THE IMPLANTED LENS. HE REFERRED THE PATIENT TO A RETINA SPECIALIST FOR FURTHER WORK-UP ON THE PATIENT'S VISUAL CONCERNS. HE ALSO STATED THAT THE PATIENT MAY NEED YAG (YTTRIUM-ALUMINUM-GARNET) LASER FOR FUTURE TREATMENT. THE ZMB00 LENS IMPLANTED IN THE PATIENT'S LEFT EYE IS BEING CAPTURED IN THIS REPORT AND A SEPARATE MDR IS BEING FILED FOR THE ZLB00 LENS IMPLANTED IN THE RIGHT EYE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 5992337 ↗