IPure B1PC (clear), +16.50DRecalls & 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 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00886158017134), received between Jul 11, 2023 and Jul 11, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Sharp Edges” (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
Device problems
- Sharp Edges1
Patient problems
- Capsular Bag Tear1
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 11, 2023Sharp Edges; Sharp Edges
INTRA-OPERATIVE COMPLICATIONS: POSTERIOR CAPSULE RUPTURE, EXPLANTATION WHILE INSERTING THE IOL IN THE BAG, THE LENS SEEMED UNSTABLE. AFTER INSPECTING THE POSTERIOR CAPSULE, IT WAS NOTED THAT THE IOL WAS THROUGH THE POSTERIOR CAPSULE. AT THAT TIME, SURGEON EXPLANTED THE IOL AND,PROCEEDED TO DO AN ANTERIOR VITRECTOMY. THE SURGEON USED ANOTHER IOL IN THE SULCUS AND THE POWER WAS CHANGED AS WELL. THE SURGERY WAS A SUCCESS. PATIENT HEALTH WAS NOT IMPACTED; PATIENT HAS RECOVERED AND IS FINE.
Patient problems: Capsular Bag Tear; Failure of Implant
MAUDE report 17297405 ↗
Other Intraocular Lens devices
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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