IPure B1PC (clear), +19.50DRecalls & reported problems
Hoya Medical Singapore Pte. Ltd. · Foldable, posterior chamber intraocular lens (IOL), preloaded in an injector that automatically folds the lens as it is advanced, prior to insertion. Single use. · Class 3 · Implant
All models of IPure (24)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00886158017196), received between Mar 23, 2022 and Jun 12, 2024 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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.
Reports received per month
Most reported problems
Device problems
- Break2
- Material Split, Cut or Torn1
- Sharp Edges1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Capsular Bag Tear1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJun 12, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
EVENT OCCURRED IN USA. DAMAGED HAPTIC AFTER IMPLANTATION. LEADING; MIDDLE; BROKEN HAPTIC DURING USE; LEADING HAPTIC DOES NOT FOLD AS PER IFU; HAPTIC STUCK TO OPTIC TEMPORARILY~ FINALLY HAPTIC IS SEPARATED. INCREASED INCISION SIZE; PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY; PATIENT HEALTH NOT IMPACTED; TORIC IOL MISALIGNMENT OR ROTATION. PROBLEM CODE: A0414, MATERIAL SPLIT CUT OR TORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19525236 ↗MalfunctionMay 17, 2022Break; Break
DAMAGED HAPTIC AFTER IMPLANTATION. BROKEN HAPTIC DURING USE; LENS WAS PARTIALLY INSERTED WHEN THEY NOTICED THE BROKEN HAPTIC AND THEN IT WAS REMOVED. PATIENT HEALTH NOT IMPACTED; PATIENT HAS RECOVERED AND IS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14418790 ↗MalfunctionMay 17, 2022Break; Break
DAMAGED HAPTIC AFTER IMPLANTATION. BROKEN HAPTIC DURING USE; LENS WAS PARTIALLY INSERTED WHEN THEY NOTICED THE BROKEN HAPTIC AND THEN IT WAS REMOVED. PATIENT HEALTH NOT IMPACTED; PATIENT HAS RECOVERED AND IS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14418384 ↗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 13862682 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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