iSert Intraocular Lens 251 (yellow), +16.00DRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04547480450216), received between May 3, 2019 and Jan 5, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Failure to Eject” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2026Insufficient Device Problem Information

  EVENT OCCURRED IN CHINA. THE HAPTIC PUNCTURED AND RUPTURED THE CAPSULE AFTER IMPLANTING THE INTRAOCULAR LENS (IOL) INTO THE CAPSULAR BAG, A POSTERIOR CAPSULE RUPTURE WAS DISCOVERED. IT WAS SUSPECTED THAT THE IOL HAPTIC HAD TORN THE POSTERIOR CAPSULE. IN THIS CASE, THE RUPTURE WAS RELATIVELY SMALL, AND DURING FOLLOW-UP NO VITREOUS PROLAPSE, ELEVATED INTRAOCULAR PRESSURE, OR LENS DISPLACEMENT HAS BEEN OBSERVED. CLOSE FOLLOW-UP WILL CONTINUE. CAPSULAR BAG TEAR / RUPTURE; POSTERIOR CAPSULE RUPTURE; PROBLEM CODE: A26 - INSUFFICIENT DEVICE PROBLEM INFORMATION.

  Patient problems: Capsular Bag Tear

  MAUDE report 23968258 ↗
• InjuryNov 26, 2024Failure to Eject; Failure to Eject

  EVENT OCCURRED IN MALAYSIA. CLOGGING. IOL GOT STUCK IN THE NOZZLE DURING INSERTION. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY. PATIENT HEALTH NOT IMPACTED. IOL WAS EXPLANTED ON (B)(6) 2024. PROBLEM CODE: A050301 - FAILURE TO EJECT.

  Patient problems: Failure of Implant

  MAUDE report 20783666 ↗
• InjuryMay 3, 2019Break; Failure to Eject; Break; Failure to Eject

  THE LENS INJECTOR WAS CORRECTLY PREPARED & HANDED OVER TO THE SURGEON; BUT AS SOON AS THE IOL WAS CAREFULLY INJECTED INTO THE CAPSULAR BAG, THE SURGEON VERBALIZED THAT THE TRAILING HAPTIC IS SOMEHOW STUCK ON THE ROD TIP AS HE CAN'T RELEASE THE TRAILING HAPTIC COMPLETELY FROM TIP. THERE WAS ALSO RESISTANCE WHEN HE ATTEMPTED TO PULL OUT THE INJECTOR FROM THE INCISION, AND IN THE END THE TRAILING HAPTIC WAS DETACHED FROM THE OPTIC; THUS, HE HAD TO MAKE A BIGGER INCISION IN ORDER TO REMOVE THE IOL THAT WAS ALREADY INSIDE THE CAPSULAR BAG. WE HAVE TO OPEN AND RELOAD A NEW LENS, BUT THIS TIME IT WENT IN SMOOTHLY WITHOUT ANY ISSUES; THEN, HE NEEDED TO SUTURE THE INCISION JUST TO MAKE SURE THE EYE WON'T LEAK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8579843 ↗