IPure B1PC (clear), +21.00DRecalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00886158017226), received between Nov 27, 2023 and Sep 10, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Sharp Edges” (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
- Sharp Edges2
- Material Split, Cut or Torn1
Patient problems
- Capsular Bag Tear2
- Failure of Implant1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 10, 2024Sharp Edges; Sharp Edges
EVENT OCCURRED IN USA. DAMAGED HAPTIC AFTER IMPLANTATION. LEADING; ROOT; BROKEN HAPTIC DURING USE. LEADING HAPTIC DOES NOT FOLDAS PER IFU. WHEN HE WENT TO SPIN THE LENS INTO PLACE IT APPEARED THE HAPTICS TORE THECAPSULE. CAPSULAR BAG TEAR / RUPTURE. PRODUCT REMAINED IN EYE AFTER CLINICAL ASSESSMENT. PATIENT HEALTH NOT IMPACTED; HE IMPLANTED LENS LIKE HE ALWAYS DOES. TORIC IOL MISALIGNMENT OR ROTATION. PROBLEM CODE: A051102 - SHARP EDGES.
Patient problems: Capsular Bag Tear
MAUDE report 20185670 ↗InjurySep 10, 2024Sharp Edges; Sharp Edges
EVENT OCCURRED IN USA. DAMAGED HAPTIC AFTER IMPLANTATION. LEADING; WHEN HE WENT TO SPIN THE LENS INTO PLACE IT APPEARED THEATRICS TORE THE CAPSULE. ROOT; BROKEN HAPTIC DURING USE. TRAILING HAPTIC DOES NOT FOLD AS PER IFU. CAPSULAR BAG TEAR / RUPTURE. PRODUCT REMAINED IN EYE AFTER CLINICAL ASSESSMENT. PATIENT HEALTH NOT IMPACTED; PATIENT HAS RECOVERED AND IS FINE. PROBLEM CODE: A051102 - SHARP EDGES.
Patient problems: Capsular Bag Tear
MAUDE report 20185572 ↗InjuryNov 27, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
EVENT OCCURRED IN USA. DAMAGED HAPTIC AFTER IMPLANTATION. IMDRF CODE: A0414, MATERIAL SPLIT CUT OR TORN. LEAD HAPTIC DID NOT TUCK PROPERLY CAME OUT STRAIGHT. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY. PATIENT HEALTH NOT IMPACTED. IOL WAS EXPLANTED ON (B)(6) 2023.
Patient problems: Failure of Implant
MAUDE report 18211730 ↗
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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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