IPure B1PC (clear), +20.00DRecalls & 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 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00886158017202), received between Mar 24, 2022 and Dec 29, 2023 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn2
- Sharp Edges2
- Break1
Patient problems
- Failure of Implant4
- Capsular Bag Tear2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryDec 29, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
EVENT OCCURRED IN USA. DAMAGED HAPTIC AFTER IMPLANTATION. LENS WAS CUT IN HALF AND EXPLANTED. PATIENT HEALTH NOT IMPACTED. PATIENT HASRECOVERED AND IS FINE. IMDRF CODE: A0414, MATERIAL SPLIT CUT OR TORN. IOL WAS EXPLANTED ON (B)(6) 2023.
Patient problems: Failure of Implant
MAUDE report 18418795 ↗InjuryJul 11, 2023Sharp Edges; Sharp Edges
INTRA-OPERATIVE COMPLICATIONS: POSTERIOR CAPSULE RUPTURE. IT WAS REPORTED: LENS ON FIELD; POSTERIOR CAPSULE BREAK; COULD NOT USE LENS. PATIENT HEALTH NOT IMPACTED; PATIENT HAS RECOVERED AND IS FINE.
Patient problems: Capsular Bag Tear
MAUDE report 17297392 ↗InjuryJun 7, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
DAMAGED HAPTIC AFTER IMPLANTATION. THE DOCTOR WAS INSERTING THE IOL INTO THE LEFT EYE OF PATIENT AND THE HAPTIC BROKE IN THE EYE. THE IOL WAS EXPLANTED, AND THEN INSERTED ANOTHER IOL AND SUCCESSFULLY. PATIENT IMPACT: EXPLANTATION. PATIENT HEALTH NOT IMPACTED; PATIENT HAS RECOVERED AND IS FINE.
Patient problems: Failure of Implant
MAUDE report 17080622 ↗InjuryFeb 21, 2023Sharp Edges; Sharp Edges
DR. INSERTED THE LENS INTO THE BAG AND THE BAG TORE. THE DOCTOR FEELS THAT THE LENS HAD SHARP EDGE THAT CAUSED THE BAG TO RIP. LENS WAS EXPLANTED. PATIENT HEALTH WAS NOT IMPACTED.
Patient problems: Capsular Bag Tear; Failure of Implant
MAUDE report 16410688 ↗MalfunctionMar 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; NO PERMANENT OR NEGATIVE IMPACT ON PATIENT HEALTH EXPECTED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 13875039 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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