IPure B1PC (clear), +19.00DRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00886158017189), received between Mar 23, 2022 and Mar 4, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  EVENT OCCURRED IN USA DAMAGED HAPTIC AFTER IMPLANTATION PROBLEM CODE: A0414, MATERIAL SPLIT CUT OR TORN TRAILING; DR IMPLANTED LENS TRAIL HAPTIC BROKEN NOTICED DURING SURGERY LENS HAD TO BE EXPLANTED AND REPLACED WITH A SULCUS LENS JJ ZA9003 PATIENT HEALTH NOT IMPACTED; NO PERMANENT OR NEGATIVE IMPACT ON PATIENT HEALTH EXPECTED EXPLANTATION DATE: (B)(6) 2023.

  Patient problems: Failure of Implant

  MAUDE report 18831007 ↗
• InjuryAug 25, 2022Unintended Ejection; Unintended Ejection

  INTRA-OPERATIVE COMPLICATIONS; IOL RELEASE ISSUE. SURGEON STATED THAT LENS UNFOLDED VERY FAST, LENS HAD ALREADY STARTED TO UNFOLD AS THE LENS ENTERED THE CAPSULE. SOME BLEEDING OF THE IRIS OCCURRED WHILE TRYING TO PUT THE LENS INTO THE BAG. SURGEON WAS NOT ABLE TO GET THE LENS INTO THE BAG WITHOUT THE POTENTIAL FOR FURTHER COMPLICATIONS. DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY. PATIENT IMPACT: DEVICE EXPLANTATION. PATIENT HAS RECOVERED AND IS FINE.

  Patient problems: Failure of Implant; Hyphema

  MAUDE report 15294441 ↗
• InjuryMar 24, 2022Break; Break

  DAMAGED HAPTIC AFTER IMPLANTATION HAPTIC WAS BROKEN WHEN THEY INSERTED LENS. DR HAD TO ENLARGE INCISION TO REMOVE THE HAPTIC. DR THEN EXPLANTED THE LENS. PATIENT HEALTH NOT IMPACTED; PATIENT HAS RECOVERED AND IS FINE.

  Patient problems: Failure of Implant

  MAUDE report 13875053 ↗
• InjuryMar 23, 2022Sharp Edges; Sharp Edges

  INTRA-OPERATIVE COMPLICATIONS. POSTERIOR CAPSULE RUPTURE. DOCTOR REPORTED THAT SOMETHING HAPPENED IN THE PREPPING OF THE LENS OR IN THE INJECTOR THAT IS CUTTING THE LENS LEADING HAPTIC. THIS IS CREATING A SHARP EDGE THAT IS CAUSING THE POSTERIOR CAPSULE TO TEAR WHEN THE SHARP EDGE ON THE HAPTIC COMES IN CONTACT WITH IT. LENS STILL IN THE EYE VIA REVERSE OPTIC CAPTURE. PATIENT HAS RECOVERED AND IS FINE; PATIENT HAS 2020 AND 2030 UNCORRECTED.

  Patient problems: Capsular Bag Tear

  MAUDE report 13862355 ↗