iSert Intraocular Lens 250 (clear), +21.00DRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 04547480480800), received between Dec 1, 2015 and May 28, 2026 — classified as 16 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (7 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2026Material Split, Cut or Torn

  EVENT OCCURRED IN CHINA. DAMAGED HAPTIC AFTER IMPLANTATION AS WE CHECKED WITH THE HOSPITAL, THERE WAS NO MORE INFORMATION FOR THIS CASE, THE HOSPITAL CAN NOT CONFIRM WHICH HAPTIC WAS DAMAGED, THE ENGLISH TRANSLATION OF THIS INITIAL REPORT IS THAT A PRELOADED ASPHERIC POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) WAS DELIVERED TO THE OPERATING ROOM BY THE NURSE. DURING THE SURGICAL PROCEDURE, THE SURGEON IDENTIFIED THAT THE IOL HAPTIC WAS BROKEN, WHICH SERIOUSLY IMPACTED THE SURGICAL PROCESS. AND AFTER WE RECHECKED AGAIN, THE INCIDENT WAS INITIALLY REPORTED BY THE ADMIN IN THE HOSPITAL, BUT NOT THE SURGEON, SO INITIAL INFORMATION WAS WRONG. AN ADVERSE EVENT REPORTED IN MARCH BY (B)(6) HOSPITAL, S/N: (B)(6) AFTER COMMUNICATION WITH THE OPERATING SURGEON, IT WAS REPORTED THAT DURING IMPLANTATION, A SLIGHT FRACTURE WAS OBSERVED IN THE BLUE-COLORED PORTION OF THE HAPTIC. THE SURGEON ATTEMPTED TO IMPLANT THE LENS, BUT IT WAS FOUND THAT IT COULD NOT BE PROPERLY SUPPORTED WITHIN THE CAPSULAR BAG. THEREFORE, THE IOL WAS CUT AND REMOVED. IOL WAS EXPLANTED ON (B)(6) 2026 PROBLEM CODE: A0414 - MATERIAL SPLIT, CUT OR TORN

  Patient problems: Failure of Implant

  MAUDE report 25326166 ↗
• InjuryMay 28, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT OCCURRED IN MALAYSIA. DAMAGED HAPTIC AFTER IMPLANTATION. LEADING. INCREASED INCISION SIZE. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY. PATIENT HEALTH NOT IMPACTED. IOL WAS EXPLANTED ON (B)(6) 2025. PROBLEM CODE: A0414 - MATERIAL SPLIT, CUT OR TORN.

  Patient problems: Failure of Implant

  MAUDE report 22102111 ↗
• InjuryDec 27, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT OCCURRED IN MALAYSIA. DAMAGED HAPTIC AFTER IMPLANTATION. TRAILING; TIP. INCREASED INCISION SIZE. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY. PATIENT HEALTH NOT IMPACTED. IOL WAS EXPLANTED ON (B)(6) 2024. PROBLEM CODE: A0414 - MATERIAL SPLIT, CUT OR TORN.

  Patient problems: Failure of Implant

  MAUDE report 21031274 ↗
• InjuryNov 26, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT OCCURRED IN MALAYSIA. DAMAGED HAPTIC AFTER IMPLANTATION. TRAILING; TIP; DAMAGED HAPTIC. INCREASED INCISION SIZE. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY. PATIENT HEALTH NOT IMPACTED. IOL WAS EXPLANTED ON (B)(6) 2024. PROBLEM CODE: A0414 - MATERIAL SPLIT, CUT OR TORN.

  Patient problems: Failure of Implant

  MAUDE report 20785054 ↗
• InjuryDec 9, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT OCCURRED IN CHINA. DAMAGED HAPTIC AFTER IMPLANTATION. TRAILING. IMDRF CODE: A0414, MATERIAL SPLIT CUT OR TORN. INCREASED INCISION SIZE. IOL WAS EXPLANTED ON (B)(6) 2023.

  Patient problems: Failure of Implant

  MAUDE report 18298247 ↗
• InjuryNov 22, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT OCCURRED IN MALAYSIA. DAMAGED HAPTIC AFTER IMPLANTATION. IMDRF CODE: A0414, MATERIAL SPLIT CUT OR TORN. INCREASED INCISION SIZE. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY. PATIENT HEALTH NOT IMPACTED. IOL WAS EXPLANTED ON (B)(6) 2023.

  Patient problems: Failure of Implant

  MAUDE report 18196337 ↗
• InjuryJul 12, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REPORTED CASE OF INFLAMMATION / UVEITIS IN MEXICO. THE IOL WAS IMPLANTED ON (B)(6) 2022. THE INFLAMMATION WAS OBSERVED 13 DAYS AFTER THE SURGERY - (B)(6) 2022. PATIENT WAS TREATED WITH STEROIDS AND ANTIBIOTICS FOR 3 WEEKS AND HAS RECOVERED. (B)(6) 2022: MANUFACTURER'S DATE OF AWARENESS. (B)(6) 2022: AUTHORIZED COUNTRY REPRESENTATIVE ASSESSED AS A REPORTABLE EVENT TO COFEPRIS BY END OF YEAR.

  Patient problems: Uveitis

  MAUDE report 14989069 ↗
• InjuryJun 2, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IMPLANT DATE: (B)(6) 2021. (B)(6) 2021 PROBLEMS: OPTIC OPACIFICATION. SIGNS OF INFLAMMATION/INFECTION; PRODUCT REMAINED IN EYE AFTER CLINICAL ASSESSMENT. PATIENT RETURNED TO THE HOSPITAL ON (B)(6) AND WAS DIAGNOSED AS ENDOPHTHALMITIS. PATIENT WAS TREATED WITH MOXIFLOXACIN, TOBRAMYCIN AND DEXAMETHASONE EYE DROPS, AND BROMFENAC (SODIUM HYDRATE), AFTER LAVAGE THERE WAS STILL EXUDATIVE MEMBRANE ON THE SECOND DAY. THEN A VITRECTOMY WAS PERFORMED AND THE PATIENT WAS HOSPITALIZED FOR CONTINUOUS TREATMENT. DURING THIS PERIOD, EYE DROPS WERE CONTINUOUSLY USED, AND VANCOMYCIN WAS INFUSED FOR 10 DAYS. PATIENT WAS DISCHARGED ON (B)(6) .

  Patient problems: Inflammation; Visual Impairment

  MAUDE report 11922744 ↗
• InjuryFeb 16, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  TORN HAPTIC. DAMAGED HAPTIC AFTER IMPLANTATION. EXPLANTATION CAPSULAR BAG TEAR/RUPTURE. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY. PATIENT HAS RECOVERED AND IS FINE.

  Patient problems: Capsular Bag Tear

  MAUDE report 11335401 ↗
• InjuryJun 11, 2019Break; Break

  TRAILING HAPTIC BROKE. THE LENS HAD TO BE EXPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8689667 ↗
• MalfunctionMay 3, 2019Break; Break

  AT IMPLANTATION IN THE PATIENTS EYE - THE TRAILING HAPTIC LOST ITS BLUE TIP IN THE INJECTOR. THE LENS WAS CUT AND REPLACED WITH A NEW LENS. PATIENT IMPACT: LENGTHENING OF PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8579848 ↗
• MalfunctionMay 3, 2019Break; Break

  REPORTING RELATED TO "PARTIAL SEPARATION OF PMMA/ACRYLIC JOINT NOTICED DURING IMPLANTATION". THE HAPTIC SNAPPED AWAY FROM LENS UPON INSERTION AND WAS LEFT TRAPPED INSIDE THE APPLICATOR. LENS LEFT IN PATIENT EYE. PATIENT OUTCOME: UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8579781 ↗
• InjuryAug 30, 2018Break; Break

  IT WAS REPORTED THAT THE HAPTIC BROKE OFF UPON INSERTION AND THE INCISION WAS ENLARGED TO REMOVE THE LENS INTRAOPERATIVELY. THE LENS WAS REPLACED WITH THE SAME TYPE AND DIOPTER LENS. NO SUTURES WERE REQUIRED. PATIENT PROGNOSIS IS GOOD, ALTHOUGH IT WAS NOTED THAT THERE MAY BE MORE THAN THE USUAL SWELLING POST-SURGERY.

  Patient problems: Inflammation

  MAUDE report 7835453 ↗
• InjuryJan 26, 2018Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT DEVELOPED ENDOPHTHALMITIS AFTER THE LENS WAS IMPLANTED AND THE LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED BUT HAS NOT BEEN RECEIVED.

  Patient problems: Endophthalmitis

  MAUDE report 7222810 ↗
• InjuryJan 26, 2018Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT DEVELOPED ENDOPHTHALMITIS AFTER THE LENS WAS IMPLANTED AND THE LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED BUT HAS NOT BEEN RECEIVED.

  Patient problems: Endophthalmitis

  MAUDE report 7221823 ↗
• InjuryJul 28, 2017Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A LENS HAS BEEN EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6751526 ↗
• InjuryFeb 24, 2016Sticking; Sticking

  IT WAS REPORTED THAT AN INCIDENT OCCURRED WITH THE HOYA ISERTODEL 250 LENS, IN WHICH THE PMMA TIP WAS EMBEDED INTO THE OPTIC, NOTED AFTER IOL IMPLANT. SEVERAL DIFFERENT ATTEMPTS TO UNFOLD THE HAPTIC WERE PERFORMED BY THE SURGEON. THE SURGEON CUT OUT THE LENS INTO SEVERAL PIECES FOR SEPARATION OF HAPTIC FROM THE PATIENT'S EYE. ACCORDING TO SURGEON, PATIENT PROGNOSIS IS REPORTED AS DOING FINE, WITH SOME EXPECTED CORNEAL EDEMA.

  Patient problems: Corneal Edema

  MAUDE report 5459106 ↗
• InjuryDec 1, 2015Split

  DOCTOR STATED THAT THE CARTRIDGE SPLIT AS THE INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT'S EYE CAUSING A TEAR OF THE PATIENT'S CAPSULORHEXIS. THE LENS WAS NOTED AS FINE. THE PATIENT WAS ALSO NOTED AS FINE. THE LENS WAS NOT EXPLANTED.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 5259710 ↗