iSert Intraocular Lens 250 (clear), +21.50DRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04547480480817), received between Dec 1, 2015 and Feb 27, 2026 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2026Material Split, Cut or Torn

  EVENT OCCURRED IN MALAYSIA. DAMAGED HAPTIC AFTER IMPLANTATION. TRAILING; MIDDLE; DAMAGED HAPTIC. WOUND STRETCH; 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 24466364 ↗
• InjuryDec 3, 2025Optical Decentration; Optical Decentration

  EVENT OCCURRED IN CHINA. THE PATIENT, WHO HAD SUFFERED FROM PROGRESSIVE VISUAL IMPAIRMENT IN THE RIGHT EYE FOR OVER 2 YEARS AND WAS IN THE MATURE STAGE OF CATARACT, UNDERWENT PHACOEMULSIFICATION AND INTRAOCULAR LENS (IOL) IMPLANTATION IN THE RIGHT EYE AT OUR HOSPITAL ON (B)(6) 2025. ON THE FIRST POSTOPERATIVE DAY ((B)(6) 2025), THE PATIENT WAS CONSCIOUS, IN GOOD SPIRITS, AND HAD NO DISCOMFORT SUCH AS EYE PAIN OR HEADACHE. PHYSICAL EXAMINATION REVEALED CONJUNCTIVAL CONGESTION, CORNEAL ENDOTHELIAL EDEMA AND FOLDS, A NORMAL ANTERIOR CHAMBER DEPTH, A PUPIL DIAMETER OF 2.5 MM, AND A WELL-POSITIONED IOL WITH GOOD REFLECTION. THE PATIENT REQUESTED DISCHARGE AND WAS DISCHARGED ACCORDINGLY. ON THE MORNING OF THE SECOND POSTOPERATIVE DAY ((B)(6) 2025), THE PATIENT RETURNED TO OUR OUTPATIENT CLINIC COMPLAINING OF PAIN IN THE OPERATED EYE. THE INTRAOCULAR PRESSURE WAS FOUND TO BE ELEVATED, AND THE IOL WAS DISLOCATED INFEROTEMPORALLY. THE PHYSICIAN ADMINISTERED 250 ML OF 20% MANNITOL INTRAVENOUSLY TO LOWER THE INTRAOCULAR PRESSURE, AND THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO ANOTHER HOSPITAL FOR FURTHER TREATMENT. AT THE EXTERNAL HOSPITAL, THE PATIENT UNDERWENT "VITRECTOMY AND IOL REPOSITIO

  Patient problems: Failure of Implant

  MAUDE report 23711783 ↗
• InjuryDec 27, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT OCCURRED IN MALAYSIA. DAMAGED HAPTIC AFTER IMPLANTATION. TRAILING; MIDDLE. CORNEAL EDEMA; INCREASED INCISION SIZE. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY. PATIENT HEALTH NOT IMPACTED. NO PERMANENT OR NEGATIVE IMPACT ON PATIENT HEALTH EXPECTED. IOL WAS EXPLANTED ON (B)(6)2024. PROBLEM CODE: A0414 - MATERIAL SPLIT, CUT OR TORN.

  Patient problems: Failure of Implant

  MAUDE report 21029269 ↗
• InjuryAug 21, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT OCCURRED IN CHINA. DAMAGED HAPTIC AFTER IMPLANTATION. TRAILING; ROOT; DAMAGED HAPTIC. 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 20013864 ↗
• InjuryNov 21, 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. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY. WOUND STRETCH; INCREASED INCISION SIZE. IOL WAS EXPLANTED ON (B)(6) 2023.

  Patient problems: Failure of Implant

  MAUDE report 18188554 ↗
• InjuryMay 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANT DATE: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. EVENT OCCURRED IN (B)(6). MANUFACTURER'S DATE OF AWARENESS: 19 APR 2022 INFLAMMATION; CORNEAL EDEMA, BULBAR HYPEREMIA, BLURRY VISION, CELL ADHESION. PATIENT CONDITION AND SYMPTOMS: VISUAL DISTRIBANCES. HEALTH IMPACT: MEDICATION REQUIRED.

  Patient problems: Visual Disturbances

  MAUDE report 14418493 ↗
• MalfunctionDec 8, 2017Break; Detachment Of Device Component

  FOLLOW-UP REPORT: IT WAS STATED THAT THE TRAILING LENS HAPTIC WAS FOUND TO BE MISSING AFTER INSERTION OF THE LENS. THE BROKEN HAPTIC HAD REMAINED INSIDE THE CARTRIDGE. IT WAS ALSO CLARIFIED THAT NO INCISION ENLARGEMENT OR SUTURES WERE REQUIRED FOR THIS SURGERY. THE PHYSICIAN ATTRIBUTED THE ISSUE TO THE LENS BECOMING STUCK IN THE DELIVERY DEVICE. REGARDING THE PROGNOSIS, THE PATIENT IS DOING WELL. BASED ON THIS INFORMATION, THE REPORTED EVENT IS NO LONGER CONSIDERED SERIOUS.

  Patient problems: Tissue Damage

  MAUDE report 7100720 ↗
• InjuryFeb 1, 2017Packaging Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED HOYA 250 LENS ON (B)(6) 2016 AT OUTPATIENT SURGICAL CENTER IN (B)(6). AFTER 2 MONTHS, (B)(6) 2016 THE SURGEON REMOVED THE LENS DUE TO "POWER MISS." ON JAN 13, 2017 HOYA RECEIVED INFORMATION FROM B AND L STATING THE SURGEON BELIEVED THE HOYA IOL WAS MISLABELED. ON (B)(6) 2016 THE HOYA LENS WAS REMOVED AND REPLACED WITH A B AND L LI61AO MODEL LENS +18.5 DIOPTER. ON (B)(6) 2017 MODEL LI61AO +18.5 DIOPTER LENS WAS EXCHANGED AND SURGEON BELIEVED A "POWER MISS" AND REPLACED WITH LI61AO + 20.0 DIOPTER. ALSO REPORTED HOYA LENS NHR505R1 +21.5 WAS IMPLANTED ON (B)(6) 2016 AND A DAY AFTER, ON (B)(6) 2016 THE PATIENT DEVELOPED MYOPIC SIGHT -4.00. THE SIZE OF CAPSULORHEXIS WAS 5.L VICTUS WITH INTENDED TARGET -2.00. PHYSICIAN BELIEVES BOTH HOYA AND B&L LENSES WERE MISLABELED AND TO BE THE MOST LIKELY CAUSE OF THE REFRACTIVE ERROR. THE PATIENT'S CURRENT PROGNOSIS AND TREATMENT ON (B)(6) 2017 (1 DAY POST-OP) IS EDEMA.

  Patient problems: Edema

  MAUDE report 6294668 ↗
• InjuryDec 1, 2015Insufficient Device Problem Information

  HAPTIC TORE IN THE EYE WHEN ROTATED. INCISION WAS ENLARGED TO EXPLANT THE LENS.

  Patient problems: Eye Injury

  MAUDE report 5259693 ↗