iSert Intraocular Lens 251 (yellow), +22.00DRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04547480450339), received between May 6, 2016 and Jul 31, 2026 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2026Material Split, Cut or Torn

  Event occurred in China.Damaged haptic after/during implantation.The patient underwent cataract surgery with implantation of an intraocular lens (IOL). After the IOL was injected and implanted during the procedure, it was noted that the distal end of the posterior haptic had fractured. The broken haptic fragment remained inside the injector, resulting in loss of integrity of the implanted IOL's posterior haptic.Subsequent examination revealed no retained intraocular foreign body and no evidence of ocular structural damage at present. However, there remains a potential risk of IOL decentration/dislocation and capsular bag instability.Problem Code: A0414 - Material Split, Cut or Torn.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50108010 ↗
• InjuryMar 4, 2026Sharp Edges

  EVENT OCCURRED IN CHINA. LEADING; CAPSULAR BAG TEAR / RUPTURE; PATIENT HEALTH NOT IMPACTED. THE PATIENT, (B)(6), UNDERWENT PHACOEMULSIFICATION WITH INTRAOCULAR LENS IMPLANTATION UNDER TOPICAL ANESTHESIA ON (B)(6) 2026. DURING THE IMPLANTATION PROCESS, THE ANTERIOR HAPTIC OF THE INTRAOCULAR LENS TORE THE POSTERIOR CAPSULE WHILE UNFOLDING. AFTER ADJUSTING THE POSITION OF THE INTRAOCULAR LENS, IT WAS CENTERED IN THE CAPSULAR BAG. THE SURGERY WAS COMPLETED SMOOTHLY WITH NO ADVERSE EFFECTS. ALTHOUGH WE REQUESTED THE HOSPITAL TO PROVIDE SURGICAL PHOTOS, NO PICTURES OR VIDEOS WERE AVAILABLE FOR THE INVESTIGATION. PROBLEM CODE: A051102 - SHARP EDGES.

  Patient problems: Capsular Bag Tear

  MAUDE report 24510716 ↗
• InjuryJan 27, 2021Break; Break

  DAMAGED HAPTIC AFTER IMPLANTATION. HAPTIC TIP WAS SEPARATED AND STUCK IN INJECTOR DURING USE. INTRA-OPERATIVE EXPLANTATION, A NEW LENS WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11235921 ↗
• InjurySep 9, 2019Break; Break

  ON (B)(6) 2019 AT 10 AM, THE PATIENT WAS ACCEPTED THE SURGERY OF CATARACT PHACO AND IOL IMPLANTATION. AFTER IMPLANTATION, DOCTOR FOUND THE OPTIC OF LENS WAS INSERT INTO PATIENT EYE, HOWEVER HAPTIC WERE REMAIN AT INJECTOR, DOCTOR CONSIDERED THAT THE IOL HAS BEEN CRACKED OR BROKEN. IN ORDER TO PREVENT FROM INJURY TO THE PATIENT, DOCTOR EXPLANTED THE CRACKED IOL FROM PATIENT EYE AT 10:05AM AND REPLACED A NEW IOL TO CONTINUE WITH SURGERY. FINALLY, IT HAS BEEN DONE SUCCESSFULLY, THERE WAS NO INJURY TO PATIENT. PATIENT IMPACT: INTRA-OPERATIVE EXPLANTATION. EVENT OCCURRED IN CHINA, AND WAS REPORTED BY THE HOSPITAL AS AE TO CHINESE AUTHORITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8976751 ↗
• MalfunctionApr 4, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  WHEN THE LENS WAS INSERTED ONE OF THE HAPTICS BROKE OFF, THE LENS WAS REMOVED AND REPLACED WITH ANOTHER ONE. NO PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8484746 ↗
• InjuryJan 12, 2018Break

  IT WAS REPORTED THAT THE CAPSULAR BAG WAS BROKEN AS THE SURGEON WAS ATTEMPTING TO POSITION THE LENS IN THE EYE. THE LENS HAD TO BE REMOVED AS A RESULT. ADDITIONAL INFORMATION WAS REQUESTED BUT HAS NOT BEEN RECEIVED.

  Patient problems: No Code Available

  MAUDE report 7186099 ↗
• MalfunctionMay 6, 2016Torn Material

  THE HOYA 251 TORE DURING IOL INSERTION, AND PART OF THE TRAILING HAPTIC WAS STILL IN THE INJECTOR. THE SURGEON HAD TO ENLARGE THE INCISION TO CUT OUT THE INITIAL LENS, AND ANOTHER HOYA WAS IMPLANTED. SURGERY WAS COMPLETED AND PATIENT PROGNOSIS WAS REPORTED AS GOOD.

  Patient problems: Tissue Damage

  MAUDE report 5638008 ↗