IPure B3PC (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 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886158015772), received between Nov 13, 2020 and Jul 8, 2025 — classified as 2 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.
Reports received per month
Most reported problems
Device problems
- Break1
- Crack1
Patient problems
- Failure of Implant1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 8, 2025Crack; Crack
EVENT OCCURRED IN UNITED STATES. DAMAGED OPTIC AFTER IMPLANTATION. CRACKED OR BROKEN OPTIC (MIDDLE). THE PATIENT IS CURRENTLY STABLE. THERE WAS NO HARM TO THE PATIENT. AN IRREGULAR MAIN WOUND OCCURRED DURING THE CASE, BUT IT WAS SEALED WELL WITH SUTURE. THE PHYSICIAN REMOVED THE BISECTED OPTIC FROM THE ANTERIOR CHAMBER. THERE WILL BE NO ONGOING TREATMENT. SUTURES WILL BE REMOVED WHEN WOUND IS STABLE. IOL WAS EXPLANTED ON (B)(6) 2025. PROBLEM CODE: A0404 - CRACK.
Patient problems: Failure of Implant
MAUDE report 22446902 ↗InjuryNov 13, 2020Break; Break
IOL GOT STUCK IN THE NOZZLE DURING INSERTION. USER ERROR AS TECH PRESSED SLIDER FORWARD SHE LIKELY DISPUTED BODY OF INJECTOR CAUSING LENS TO SPLIT IN HALF. SURGEON INSERTED SPLIT LENS, WIDENED INCISION AND REMOVED IOL WITH NO INJURY TO PATIENT. PATIENT IMPACT: INTRA-OPERATIVE EXPLANT INCREASED INCISION SIZE; PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY; INCREASED INCISION REQUIRED SUTURES TO CLOSE; PATIENT HEALTH NOT IMPACTED; PATIENT HAS RECOVERED AND IS FINE; NO PERMANENT OR NEGATIVE IMPACT ON PATIENT HEALTH EXPECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10837781 ↗
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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