iSert Intraocular Lens 251 (yellow), +20.50DRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04547480450308), received between Jun 3, 2016 and Apr 15, 2026 — classified as 10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2026Sharp Edges

  EVENT OCCURRED IN CHINA. AFTER IMPLANTATION OF THE INTRAOCULAR LENS INTO THE CAPSULAR BAG, A POSTERIOR CAPSULE RUPTURE WAS NOTED. REPEATED REVIEW OF THE SURGICAL VIDEO SUGGESTED A SUSPICION THAT THE POSTERIOR CAPSULE WAS TORN BY THE IOL HAPTIC. CURRENTLY, THE INTRAOCULAR LENS REMAINS WELL POSITIONED, INTRAOCULAR PRESSURE IS NORMAL, AND VISUAL ACUITY IS 0.4. CLOSE FOLLOW-UP WILL BE CONDUCTED. CAPSULAR BAG TEAR / RUPTURE. PRODUCT REMAINED IN EYE AFTER CLINICAL ASSESSMENT. PATIENT HEALTH NOT IMPACTED PROBLEM CODE: A051102 - SHARP EDGES.

  Patient problems: Capsular Bag Tear

  MAUDE report 24891884 ↗
• InjuryJul 11, 2023Scratched Material; Scratched Material

  EVENT OCCURRED IN VIETNAM. ORIGINALLY ASSESSED AS NOT REPORTABLE TO LOCAL AUTHORITIES. OVD USED WAS REPORTED AS "UNKNOWN." DAMAGED OPTIC AFTER IMPLANTATION. PROBLEM CODE: A0415 SCRATCHED MATERIAL. IMPLANT DATE: (B)(6) 2020. EXPLANT DATE: (B)(6) 2020. PATIENT IMPACT: DEVICE EXPLANTATION.

  Patient problems: Failure of Implant

  MAUDE report 17297457 ↗
• InjuryJul 11, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT OCCURRED IN VIETNAM. ORIGINALLY ASSESSED AS NOT REPORTABLE TO LOCAL AUTHORITIES. OVD USED WAS REPORTED AS "UNKNOWN." DAMAGED HAPTIC AFTER IMPLANTATION PROBLEM CODE: (B)(4). MATERIAL SPLIT CUT OR TORN IMPLANT DATE: (B)(6) 2020. EXPLANT DATE: (B)(6)2020. PATIENT IMPACT: DEVICE EXPLANTATION.

  Patient problems: Failure of Implant

  MAUDE report 17297450 ↗
• InjuryJun 28, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT OCCURRED IN VIETNAM. ORIGINALLY ASSESSED AS NOT REPORTABLE TO LOCAL AUTHORITIES. OVD USED WAS REPORTED AS "UNKNOWN." DAMAGED HAPTIC AFTER IMPLANTATION PROBLEM CODE: A0414 MATERIAL SPLIT, CUT OR TORN IMPLANT DATE: (B)(6)2020. EXPLANT DATE: (B)(6)2020. PATIENT IMPACT: DEVICE EXPLANTATION.

  Patient problems: Failure of Implant

  MAUDE report 17218182 ↗
• InjuryJun 28, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT OCCURRED IN VIETNAM. ORIGINALLY ASSESSED AS NOT REPORTABLE TO LOCAL AUTHORITIES. OVD USED WAS REPORTED AS "UNKNOWN." DAMAGED HAPTIC AFTER IMPLANTATION PROBLEM CODE: A0414 MATERIAL SPLIT, CUT OR TORN IMPLANT DATE: (B)(6) 2020. EXPLANT DATE: (B)(6) 2020. PATIENT IMPACT: DEVICE EXPLANTATION.

  Patient problems: Failure of Implant

  MAUDE report 17218171 ↗
• InjuryDec 2, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  SURGERY DATE: (B)(6)2022. DATE OF EVENT: (B)(6)2022. POST-OPERATIVE COMPLICATIONS INFLAMMATORY RESPONSE AFTER IMPLANTATION TOXIC ANTERIOR SEGMENT SYNDROME (TASS).

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 15911712 ↗
• InjuryJul 12, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REPORTED CASE OF INFLAMMATION (B)(6). DATE OF SURGERY: (B)(6) 2022. DATE OF EVENT - NOT PROVIDED. (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 14989218 ↗
• InjuryJul 12, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REPORTED CASE OF INFLAMMATION / UVEITIS IN MEXICO. DATE OF SURGERY: (B)(6) 2022. DATE OF EVENT - NOT PROVIDED. 05-MAY-2022: MANUFACTURER'S DATE OF AWARENESS. 15-JUN-2022: AUTHORIZED COUNTRY REPRESENTATIVE ASSESSED AS A REPORTABLE EVENT TO COFEPRIS BY END OF YEAR.

  Patient problems: Uveitis

  MAUDE report 14989168 ↗
• InjuryFeb 18, 2021Material Opacification; Material Opacification

  IMPLANT DATE: (B)(6) 2020. DATE OF EVENT: (B)(6) 2021. PATIENT HAS DEVELOPED POSTERIOR CAPSULAR OPACIFICATION AFTER IMPLANTATION OF IOL. THIS RESULTED IN DROP IN VISUAL ACUITY. YAG NG TREATMENT DONE AND THE CONDITION OF THE PATIENT IS BETTER THAN PREVIOUS.

  Patient problems: Visual Impairment

  MAUDE report 11346076 ↗
• InjuryMay 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INITIAL COMPLAINT INFORMATION RECEIVED FROM DISTRIBUTOR STATED THAT: "THE TECH STATED THE CAPSULE TORE AFTER THE IOL WAS IMPLANTED. THE IOL WAS THEN EXPLANTED AND REPLACED WITH A DIFFERENT IOL." ADDITIONAL INFORMATION IN THE DATA COLLECTION FORM RECEIVED FROM THE DISTRIBUTOR INDICATED THAT: "CAPSULE TORE WHEN IOL INSERTED. SURGEON THEN REMOVED THE IOL, PERFORMED A VITRECTOMY, AND INSERTED A DIFFERENT IOL." "IOL WAS REMOVED/EXPLANTED - DATE: (B)(6) 2018"

  Patient problems: Capsular Bag Tear; Vitrectomy; Vitreous Loss

  MAUDE report 7542008 ↗
• MalfunctionJun 3, 2016Entrapment of Device; Material Split, Cut or Torn

  TORN HAPTIC WAS REPORTED DURING IOL INSERTION. THE TRAILING HAPTIC WAS STUCK IN THE INTRODUCER. THE IOL WAS STILL USED. PATIENT OUTCOME IS UNKNOWN AT THIS TIME. THE LENS WAS NOT EXPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5698955 ↗