Sharpoint 74-1010Recalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · 2.0mm Sharptome™ Crescent Knife Angled, Bevel Up · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848782028351), received between Dec 9, 2022 and Jul 17, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Loose or Intermittent Connection1
Patient problems
- Bacterial Infection1
- Eye Injury1
- Itching Sensation1
- Laceration(s)1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 17, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED DURING THE SURGICAL PROCEDURE WHEN THE SURGEON USED THE KNIFE TO MAKE THE INCISION, THE BLADE TURNED OVER RESULTING IN DAMAGING THE CORNEAL ENDOTHELIUM. THE SURGEON REMOVED THE KNIFE AND REPLACED WITH A NEW ONE. NO ADDITIONAL INJURIES REPORTED.
Patient problems: Eye Injury; Laceration(s)
MAUDE report 19762186 ↗InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2022, DURING THE SURGERY, THERE WAS DEFORMATION OF THE BLADE, THE PATIENT''S EYES WERE ITCHY AFTER SURGERY, AND THERE WAS INFECTION. THE PATIENT REQUIRED A SECOND SURGERY TO REMEDY THE INFECTION DUE TO DAMAGE TO THE EXTERNAL TISSUES, AND THE SUBSEQUENT SURGERY WAS SUCCESSFUL, AND THE PATIENT STATUS WAS STABLE. ADRS REPORT CODE (B)(4).
Patient problems: Bacterial Infection; Itching Sensation
MAUDE report 15947839 ↗
Other Knife, ophthalmic devices
- ClearCut® 8065921541Alcon Laboratories, Inc. · Knife, ophthalmic2 recalls215 reports
- ClearCut®; Intrepid 8065992445Alcon Laboratories, Inc. · Knife, ophthalmic2 recalls170 reports
- ClearCut®; Intrepid 8065982465Alcon Laboratories, Inc. · Knife, ophthalmic1 recall153 reports
- V-Lance 8065912001Alcon Laboratories, Inc. · Knife, ophthalmic2 recalls68 reports
- ClearCut® 8065771541Alcon Laboratories, Inc. · Knife, ophthalmic2 recalls38 reports
- ClearCut® 8065771540Alcon Laboratories, Inc. · Knife, ophthalmic2 recalls30 reports
- ClearCut®; Intrepid 8065772465Alcon Laboratories, Inc. · Knife, ophthalmic2 recalls7 reports
- ClearCut®; Intrepid 8065982265Alcon Laboratories, Inc. · Knife, ophthalmic104 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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