SHARKSKIN 706.88Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07612717071537), received between Aug 29, 2023 and Sep 12, 2023 — classified as 4 injuries.

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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THROUGH A LITERATURE STUDY REGARDING THE UTILIZATION OF INTRAOPERATIVE OCT (IOCT) GUIDANCE FOR THE REMOVAL OF EPIRETINAL MEMBRANE (ERM) AND INTERNAL LIMITING MEMBRANE (ILM). THIS PROCEDURE INVOLVED THE USE OF OPHTHALMIC FORCEPS WITH A LASER-ABLATED TIP SURFACE. THE STUDY INCLUDED PATIENTS WHO HAD UNDERGONE 23- AND 25-GAUGE PARS PLANA VITRECTOMY (PPV) TO ADDRESS VITREORETINAL INTERFACE DISORDERS. THE SURGERY INVOLVED FACILITATING THE REMOVAL OF ERM AND ILM USING MICROSCOPE-INTEGRATED IOCT AND OPHTHALMIC FORCEPS. IN ADDITION, TWO PATIENTS WITH IDIOPATHIC MACULAR PUCKER DISEASE WHO HAD UNDERGONE VITRECTOMY EXPERIENCED RETINAL HEMORRHAGE. SUBSEQUENT IOCT VIDEO ANALYSIS CONDUCTED AFTER THE SURGERY REVEALED HYPERREFLECTIVITY OF THE INNER RETINAL LAYERS, WHICH WAS ASSOCIATED WITH RETINAL HEMORRHAGE IN BOTH PATIENTS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17727154 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THROUGH A LITERATURE STUDY REGARDING THE UTILIZATION OF INTRAOPERATIVE OCT (IOCT) GUIDANCE FOR THE REMOVAL OF EPIRETINAL MEMBRANE (ERM) AND INTERNAL LIMITING MEMBRANE (ILM). THIS PROCEDURE INVOLVED THE USE OF OPHTHALMIC FORCEPS WITH A LASER-ABLATED TIP SURFACE. THE STUDY INCLUDED PATIENTS WHO HAD UNDERGONE 23- AND 25-GAUGE PARS PLANA VITRECTOMY (PPV) TO ADDRESS VITREORETINAL INTERFACE DISORDERS. THE SURGERY INVOLVED FACILITATING THE REMOVAL OF ERM AND ILM USING MICROSCOPE-INTEGRATED IOCT AND OPHTHALMIC FORCEPS. IN ADDITION, TWO PATIENTS WITH IDIOPATHIC MACULAR PUCKER DISEASE WHO HAD UNDERGONE VITRECTOMY EXPERIENCED RETINAL HEMORRHAGE. SUBSEQUENT IOCT VIDEO ANALYSIS CONDUCTED AFTER THE SURGERY REVEALED HYPERREFLECTIVITY OF THE INNER RETINAL LAYERS, WHICH WAS ASSOCIATED WITH RETINAL HEMORRHAGE IN BOTH PATIENTS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17727153 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THROUGH A LITERATURE STUDY REGARDING THE UTILIZATION OF INTRAOPERATIVE OCT (IOCT) GUIDANCE FOR THE REMOVAL OF EPIRETINAL MEMBRANE (ERM) AND INTERNAL LIMITING MEMBRANE (ILM). THIS PROCEDURE INVOLVED THE USE OF OPHTHALMIC FORCEPS WITH A LASER-ABLATED TIP SURFACE. THE STUDY INCLUDED PATIENTS WHO HAD UNDERGONE 23- AND 25-GAUGE PARS PLANA VITRECTOMY (PPV) TO ADDRESS VITREORETINAL INTERFACE DISORDERS. THE SURGERY INVOLVED FACILITATING THE REMOVAL OF ERM AND ILM USING MICROSCOPE-INTEGRATED IOCT AND OPHTHALMIC FORCEPS. IN ADDITION, TWO PATIENTS WITH IDIOPATHIC MACULAR PUCKER DISEASE WHO HAD UNDERGONE VITRECTOMY EXPERIENCED RETINAL HEMORRHAGE. SUBSEQUENT IOCT VIDEO ANALYSIS CONDUCTED AFTER THE SURGERY REVEALED HYPERREFLECTIVITY OF THE INNER RETINAL LAYERS, WHICH WAS ASSOCIATED WITH RETINAL HEMORRHAGE IN BOTH PATIENTS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17727095 ↗
• InjuryAug 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THROUGH A LITERATURE STUDY REGARDING THE UTILIZATION OF INTRAOPERATIVE OCT (IOCT) GUIDANCE FOR THE REMOVAL OF EPIRETINAL MEMBRANE (ERM) AND INTERNAL LIMITING MEMBRANE (ILM). THIS PROCEDURE INVOLVED THE USE OF OPHTHALMIC FORCEPS WITH A LASER-ABLATED TIP SURFACE. THE STUDY INCLUDED PATIENTS WHO HAD UNDERGONE 23- AND 25-GAUGE PARS PLANA VITRECTOMY (PPV) TO ADDRESS VITREORETINAL INTERFACE DISORDERS. THE SURGERY INVOLVED FACILITATING THE REMOVAL OF ERM AND ILM USING MICROSCOPE-INTEGRATED IOCT AND OPHTHALMIC FORCEPS. IN ADDITION, TWO PATIENTS WITH IDIOPATHIC MACULAR PUCKER DISEASE WHO HAD UNDERGONE VITRECTOMY EXPERIENCED RETINAL HEMORRHAGE. SUBSEQUENT IOCT VIDEO ANALYSIS CONDUCTED AFTER THE SURGERY REVEALED HYPERREFLECTIVITY OF THE INNER RETINAL LAYERS, WHICH WAS ASSOCIATED WITH RETINAL HEMORRHAGE IN BOTH PATIENTS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17643040 ↗