IPureRecalls & reported problems across all models
Hoya Medical Singapore Pte. Ltd. · 24 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 49
- Deaths reported
- 0
- Injuries reported
- 41
- Recalls
- 0
We found 24 models of IPure by Hoya Medical Singapore Pte. Ltd. in the FDA's device registry (GUDID). Together they are named in 49 adverse event reports in the FDA's MAUDE database, received between Nov 13, 2020 and Jul 8, 2025 — classified as 41 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (16 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported IPure problems
Device problems
- Material Split, Cut or Torn16
- Sharp Edges14
- Break10
- Failure to Eject2
- Material Twisted/Bent2
- Crack1
- Device Handling Problem1
- Failure to Fold1
Patient problems
- Failure of Implant28
- Capsular Bag Tear17
- No Clinical Signs, Symptoms or Conditions10
- Hyphema1
- Insufficient Information1
- Unspecified Tissue Injury1
IPure models
24 models, most reported first. Each model has its own page with its reports, recalls and device details.
- IPure B1PC (clear), +20.00DIntraocular Lens5 reports
- IPure B1PC (clear), +23.00DIntraocular Lens5 reports
- IPure B1PC (clear), +19.00DIntraocular Lens4 reports
- IPure B1PC (clear), +19.50DIntraocular Lens4 reports
- IPure B1PC (clear), +21.50DIntraocular Lens4 reports
- IPure B1PC (clear), +17.00DIntraocular Lens3 reports
- IPure B1PC (clear), +21.00DIntraocular Lens3 reports
- IPure B1PC (clear), +22.00DIntraocular Lens3 reports
- IPure B3PC (clear), +19.50DIntraocular Lens2 reports
- IPure B1PY (yellow), +19.50DIntraocular Lens2 reports
- IPure B3PC (clear), +20.00DIntraocular Lens1 report
- IPure B3PC (clear), +26.00DIntraocular Lens1 report
- IPure B3PC (clear), +28.00DIntraocular Lens1 report
- IPure B1PC (clear), +11.50DIntraocular Lens1 report
- IPure B1PC (clear), +15.00DIntraocular Lens1 report
- IPure B1PC (clear), +16.50DIntraocular Lens1 report
- IPure B1PC (clear), +18.50DIntraocular Lens1 report
- IPure B1PC (clear), +20.50DIntraocular Lens1 report
- IPure B1PC (clear), +22.50DIntraocular Lens1 report
- IPure B1PC (clear), +24.50DIntraocular Lens1 report
- IPure B1PC (clear), +25.50DIntraocular Lens1 report
- IPure B1PC (clear), +26.00DIntraocular Lens1 report
- IPure B1PY (yellow), +25.00DIntraocular Lens1 report
- IPure B3PC (clear), +18.50DIntraocular Lens1 report
Recent IPure adverse event reports
The 15 most recent reports across all models, 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 ↗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; ROOT; HAPTICS ON DEVICE DUE TO PC TEAR RUPTURE DURING IOL IMPLANTATION. BROKEN HAPTIC DURING USE; LEADING HAPTIC DOES NOT FOLD AS PER IFU. HAPTIC STUCK TOOPTIC TEMPORARILY~ FINALLY HAPTIC IS SEPARATED. CAPSULAR BAG TEAR / RUPTURE. PRODUCT REMAINED IN EYE AFTER CLINICAL ASSESSMENT; PATIENT HEALTH NOT IMPACTED. PATIENT HAS RECOVERED AND IS FINE; LENS DEPLOYED AS NORMAL. PROBLEM CODE: A051102 - SHARP EDGES.
Patient problems: Capsular Bag Tear
MAUDE report 20185616 ↗InjurySep 10, 2024Sharp Edges; Sharp Edges
EVENT OCCURRED IN USA. DAMAGED HAPTIC AFTER IMPLANTATION. LEADING; ROOT. WHEN HE WENT TO SPIN THE LENS INTO PLACE IT APPEARED THE HAPTICS TORE THE CAPSULE. BROKEN HAPTIC DURING USE. CAPSULAR BAG TEAR / RUPTURE. PRODUCT REMAINED IN EYE AFTER CLINICAL ASSESSMENT. HE LEFT LENS IMPLANTED; PATIENT HEALTH NOT IMPACTED. PATIENT HAS RECOVERED AND IS FINE; LENS DEPLOYED AS NORMAL. TORIC IOL MISALIGNMENT OR ROTATION. PROBLEM CODE: A051102 - SHARP EDGES
Patient problems: Capsular Bag Tear
MAUDE report 20185598 ↗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 ↗InjurySep 10, 2024Sharp Edges; Sharp Edges
EVENT OCCURRED IN USA. DAMAGED HAPTIC AFTER IMPLANTATION. WHEN HE WENT TO SPIN THE LENS INTO PLACE IT APPEARED THE HAPTICS TORE THE CAPSULE. ROOT; BROKEN HAPTIC DURING USE; 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. HE LEFT LENS IMPLANTED. BUT QUESTIONED WHETHER THE HAPTICS HAD CHANGED. LENS DEPLOYED AS NORMAL. WHEN HE WENT TO ROTATE THE HAPTICS TORE THE BAG. PROBLEM CODE: A051102 - SHARP EDGES.
Patient problems: Capsular Bag Tear
MAUDE report 20185361 ↗InjuryJun 12, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
EVENT OCCURRED IN USA. DAMAGED HAPTIC AFTER IMPLANTATION. LEADING; TIP; DAMAGED HAPTIC; 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; PROBLEM CODE: A0414, MATERIAL SPLIT CUT OR TORN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19525243 ↗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 ↗InjuryMar 4, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
EVENT OCCURRED IN USA DAMAGED HAPTIC AFTER IMPLANTATION PROBLEM CODE: A0414, MATERIAL SPLIT CUT OR TORN TRAILING; DR IMPLANTED LENS TRAIL HAPTIC BROKEN NOTICED DURING SURGERY LENS HAD TO BE EXPLANTED AND REPLACED WITH A SULCUS LENS JJ ZA9003 PATIENT HEALTH NOT IMPACTED; NO PERMANENT OR NEGATIVE IMPACT ON PATIENT HEALTH EXPECTED EXPLANTATION DATE: (B)(6) 2023.
Patient problems: Failure of Implant
MAUDE report 18831007 ↗InjuryFeb 16, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
EVENT OCCURRED IN USA. DAMAGED HAPTIC AFTER IMPLANTATION. PROBLEM CODE: A0414, MATERIAL SPLIT CUT OR TORN. TRAILING; LENS WAS IMPLANTED AND THEN HAD TO BE EXPLANTED DUE TO BROKEN TRAIL HAPTIC PATIENT HEALTH NOT IMPACTED; PATIENT HAS RECOVERED AND IS FINE; NO PERMANENT OR NEGATIVE IMPACT ON PATIENT HEALTH EXPECTED. EXPLANTATION DATE: (B)(6) 2023.
Patient problems: Failure of Implant
MAUDE report 18724493 ↗InjuryJan 9, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
COMPLAINT REFERENCE (B)(4). DAMAGED HAPTIC AFTER IMPLANTATION. IMDRF CODE: A0414, MATERIAL SPLIT CUT OR TORN. LEADING HAPTIC BROKE OFF UPON INSERTION IOL NEEDED TO BE CUTOUT OF PATIENTS EYE AND ANOTHER B1PY WAS SUCCESSFULLY IMPLANTED BY THE SURGEON (B)(6) TO THE PATIENT. IOL WAS EXPLANTED ON (B)(6) 2023.
Patient problems: Failure of Implant
MAUDE report 18476318 ↗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 ↗InjuryDec 20, 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. LEADING HAPTIC BROKE OFF UPON INSERTION IOL NEEDED TO BE CUTOUT OF PATIENTS EYE AND ANOTHER B1PY WAS SUCCESSFULLY IMPLANTED BY THE SURGEON NOHARM TO THE PATIENT IOL WAS EXPLANTED ON (B)(6) 2023.
Patient problems: Failure of Implant
MAUDE report 18369675 ↗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 ↗InjurySep 12, 2023Failure to Fold; Failure to Fold
INTRA-OPERATIVE COMPLICATIONS: POSTERIOR CAPSULE RUPTURE, EXPLANTATION. LEAD HAPTIC UNFOLDED INFERIORLY AND BROKE THE BAG AND DOCTOR HAD TO PERFORM A VITRECTOMY. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY. PATIENT IMPACT: DEVICE EXPLANTATION.
Patient problems: Capsular Bag Tear; Failure of Implant
MAUDE report 17733639 ↗
Other Hoya Medical Singapore Pte. Ltd. products
All Hoya Medical Singapore Pte. Ltd. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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