iSert Intraocular Lens 250 (clear), +22.50DRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04547480480831), received between Jun 20, 2016 and Feb 27, 2026 — classified as 15 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inaccurate Information” (8 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 17 most recent of 17 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 24466412 ↗
• InjuryDec 27, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT OCCURRED IN MALAYSIA. DAMAGED HAPTIC AFTER IMPLANTATION. TRAILING; MIDDLE. 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 21031302 ↗
• 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 20785985 ↗
• InjuryJul 12, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REPORTED CASE OF INFLAMMATION (B)(6). THE IOL WAS IMPLANTED ON (B)(6) 2021. THE INFLAMMATION WAS FIRST REPORTED BY PATIENT WITHIN WEEK 3. 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 14989177 ↗
• InjuryJul 12, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REPORTED CASE OF INFLAMMATION / UVEITIS IN MEXICO. (B)(6) 2022: MANUFACTURER'S FIRST DATE OF AWARENESS. THE IOL WAS IMPLANTED ON (B)(6) 2022. THE INFLAMMATION WAS FIRST REPORTED BY PATIENT WITHIN WEEK 3. PATIENT WAS TREATED WITH STEROIDS AND ANTIBIOTICS. RESOLUTION OF INFLAMMATION WAS NOTED ON (B)(6) 2022. (B)(6) 2022: AUTHORIZED COUNTRY REPRESENTATIVE ASSESSED AS A REPORTABLE EVENT TO COFEPRIS BY END OF YEAR.

  Patient problems: Uveitis

  MAUDE report 14989137 ↗
• InjuryJun 2, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IMPLANT DATE: (B)(6) 2021. ON (B)(6) 2021 PROBLEMS: OPTIC OPACIFICATION. SIGNS OF INFLAMMATION/INFECTION; PRODUCT REMAINED IN EYE AFTER CLINICAL ASSESSMENT. ON (B)(6) 2021, PATIENT RETURNED TO THE HOSPITAL FOR DIAGNOSIS AND TREATMENT AS ENDOPHTHALMITIS. PATIENT WAS CURED AFTER 3 DAYS OF MOXIFLOXACIN, TOBRAMYCIN AND DEXAMETHASONE EYE DROPS AND BROMFENAC (SODIUM HYDRATE). PATIENT HAS RECOVERED AND IS FINE.

  Patient problems: Inflammation; Visual Impairment

  MAUDE report 11922917 ↗
• InjuryDec 27, 2019Inaccurate Information; Inaccurate Information

  COMPLAINT DESCRIPTION: PATIENT GOT 5 DIOPTRE MYOPIA. ERROR OF PREDICTED REFRACTIVE. SEVERE DYSPHOTOPSIA. 58 YEARS OLD, MALE, WHITE. IMPLANT DATE WAS (B)(6) 2019. PATIENT IMPACT: ADDITIONAL INFORMATION: MYOPIA, REFRACTIVE ERROR, SEVERE DYSPHOTOPSIA, PERMANENT OR NEGATIVE IMPACT ON PATIENT HEALTH EXPECTED. SECONDARY SURGERY REQUIRED ON FUTURE DATE.

  Patient problems: Visual Impairment

  MAUDE report 9527306 ↗
• InjuryDec 27, 2019Inaccurate Information; Inaccurate Information

  COMPLAINT DESCRIPTION: PATIENT GOT 5 DIOPTRE MYOPIA. ERROR OF PREDICTED REFRACTIVE. SEVERE DYSPHOTOPSIA. 54 YEARS OLD, FEMALE, WHITE. IMPLANT DATE WAS (B)(6) 2019. PATIENT IMPACT: ADDITIONAL INFORMATION: MYOPIA, REFRACTIVE ERROR, SEVERE DYSPHOTOPSIA, PERMANENT OR NEGATIVE IMPACT ON PATIENT HEALTH EXPECTED. SECONDARY SURGERY REQUIRED ON FUTURE DATE.

  Patient problems: Visual Impairment

  MAUDE report 9527299 ↗
• InjuryDec 27, 2019Inaccurate Information; Inaccurate Information

  COMPLAINT DESCRIPTION: PATIENT GOT 5 DIOPTRE MYOPIA. ERROR OF PREDICTED REFRACTIVE. SEVERE DYSPHOTOPSIA. PATIENT IMPACT - ADDITIONAL INFORMATION: MYOPIA, REFRACTIVE ERROR, SEVERE DYSPHOTOPSIA, PERMANENT OR NEGATIVE IMPACT ON PATIENT HEALTH EXPECTED. SECONDARY SURGERY REQUIRED ON FUTURE DATE.

  Patient problems: Visual Impairment

  MAUDE report 9527294 ↗
• InjuryDec 27, 2019Inaccurate Information; Inaccurate Information

  COMPLAINT DESCRIPTION: PATIENT GOT 3.5 DIOPTRE MYOPIA. ERROR OF PREDICTED REFRACTIVE. SEVERE DYSPHOTOPSIA. MALE, WHITE. IMPLANT DATE WAS (B)(6) 2019. PATIENT IMPACT: ADDITIONAL INFORMATION: MYOPIA, REFRACTIVE ERROR, SEVERE DYSPHOTOPSIA, PERMANENT OR NEGATIVE IMPACT ON PATIENT HEALTH EXPECTED. SECONDARY SURGERY REQUIRED ON FUTURE DATE.

  Patient problems: Visual Impairment

  MAUDE report 9527290 ↗
• InjuryDec 27, 2019Inaccurate Information; Inaccurate Information

  COMPLAINT DESCRIPTION: PATIENT GOT 5.25 DIOPTRE MYOPIA. ERROR OF PREDICTED REFRACTIVE. SEVERE DYSPHOTOPSIA. MALE, WHITE. IMPLANT DATE WAS (B)(6) 2019. PATIENT IMPACT: ADDITIONAL INFORMATION: MYOPIA, REFRACTIVE ERROR, SEVERE DYSPHOTOPSIA, PERMANENT OR NEGATIVE IMPACT ON PATIENT HEALTH EXPECTED. SECONDARY SURGERY REQUIRED ON FUTURE DATE.

  Patient problems: Visual Impairment

  MAUDE report 9527287 ↗
• InjuryDec 27, 2019Inaccurate Information; Inaccurate Information

  COMPLAINT DESCRIPTION: PATIENT GOT 3.5 DIOPTRE MYOPIA. ERROR OF PREDICTED REFRACTIVE. SEVERE DYSPHOTOPSIA. MALE, WHITE. IMPLANT DATE WAS (B)(6) 2019. PATIENT IMPACT: ADDITIONAL INFORMATION: REFRACTIVE ERROR, MYOPIA, SEVERE DYSPHOTOPSIA, PERMANENT OR NEGATIVE IMPACT ON PATIENT HEALTH EXPECTED. SECONDARY SURGERY REQUIRED ON FUTURE DATE.

  Patient problems: Visual Impairment

  MAUDE report 9527277 ↗
• InjuryDec 27, 2019Inaccurate Information; Inaccurate Information

  COMPLAINT DESCRIPTION: PATIENT GOT MYOPIA. ERROR OF PREDICTED REFRACTIVE. SEVERE DYSPHOTOPSIA. FEMALE, WHITE. IMPLANT DATE WAS (B)(6) 2019. PATIENT IMPACT ADDITIONAL INFORMATION: REFRACTIVE ERROR, MYOPIA, SEVERE DYSPHOTOPSIA, PERMANENT OR NEGATIVE IMPACT ON PATIENT HEALTH EXPECTED. SECONDARY SURGERY REQUIRED ON FUTURE DATE.

  Patient problems: Visual Impairment

  MAUDE report 9527270 ↗
• InjuryDec 27, 2019Inaccurate Information; Inaccurate Information

  COMPLAINT DESCRIPTION: REFRACTIVE SURPRISE -4.5DPT. ACCORDING TO CUSTOMER ALL LENSES 22.5 DPT WITH EXP DATE 20210531 HAVE THIS PROBLEM. PATIENT IMPACT: REFRACTIVE ERROR, MYOPIA, SEVERE DYSPHOTOPSIA.

  Patient problems: Visual Impairment

  MAUDE report 9527261 ↗
• MalfunctionMay 3, 2019Break; Break

  REPORTING RELATED TO "BREAKAGE IN THE ACRYLIC PART OF THE HAPTIC NOTICED DURING OR AFTER IMPLANTATION". BROKEN HAPTIC, LENS LEFT IN PATIENT EYE / LENS LEFT IN SITU. PATIENT OUTCOME: UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8579787 ↗
• InjurySep 14, 2018Break; Break

  IT WAS REPORTED THAT "THE LENS TRAILING HAPTIC BROKE OFF UPON INSERTION INTO THE PATIENT'S LEFT EYE. THE SURGEON ENLARGED THE INCISION AND USED SCISSORS TO CUT THE LENS IN HALF AND SAFELY REMOVED FROM THE EYE. A DIFFERENT LENS WAS IMPLANTED INTRAOPERATIVELY WITHOUT ISSUES. THE POSTERIOR CAPSULE REMAINED INTACT. PATIENT IS DOING GOOD."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7878250 ↗
• MalfunctionJun 20, 2016Break

  IT WAS REPORTED THAT ONE OF THE "LEGS" (HAPTIC) WAS ALMOST COMPLETELY OFF. THIS WAS NOTICED WHEN THE LENS WAS CLOSE TO BEING FULLY IMPLANTED. THE LENS WAS THEN REMOVED AND REPLACED. PATIENT OUTCOME IS UNKNOWN AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 5736135 ↗