Sharpoint 72-1501Recalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · 15 DEGREE MICROKNIFE · Class 1
- 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 00848782027293), received between Jun 27, 2024 and Dec 31, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Dull, Blunt” (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
- Dull, Blunt1
- Insufficient Device Problem Information1
Patient problems
- Laceration(s)2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 31, 2025Dull, Blunt; Dull, Blunt
IT WAS REPORTED ON (B)(6) 2025, THAT A BLADE WAS DULL, INTRAOPERATIVELY. PATIENT INJURY OCCURRED WHICH RESULTED IN A DELAY TO SURGERY. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Laceration(s)
MAUDE report 23936407 ↗InjuryJun 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE BLADE WAS TURNING DURING THE SURGICAL PROCEDURE. A KNIFE WAS USED TO MAKE AN AUXILIARY INCISION WITH AN OPHTHALMIC SCALPEL AND IT WAS FOUND THAT THE BLADE OF THE KNIFE WAS TURNED OVER, WHICH RESULTED IN UNEVENNESS OF THE INCISION AND DAMAGE TO THE CORNEAL ENDOTHELIUM AFTER PUNCTURE. INTERVENTION WAS MADE DURING THE SURGICAL PROCEDURE TO REDUCE THE INFECTION CAUSED BY POOR INCISION CLOSURE AND COMPLETED THE SURGICAL PROCEDURE. THE PATIENT WAS TREATED WITH AN OPERATION CALLED "ULTRASONIC EMULSIFICATION REMOVAL OF CATARACT AND IOL IMPLANTATION IN THE RIGHT EYE" UNDER LOCAL ANESTHESIA.
Patient problems: Laceration(s)
MAUDE report 19629618 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.