SHARKSKIN 705.88PRecalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 07612717071544), received between Sep 2, 2021 and Apr 2, 2026 — classified as 7 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (25 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, 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Activation Problem

  A CUSTOMER REPORTED THAT DURING SURGERY, CLAMPS IN THE OPHTHALMIC FORCEPS DID NOT OPEN. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24765380 ↗
• MalfunctionSep 17, 2025Difficult to Open or Close; Difficult to Open or Close

  A PHYSICIAN REPORTED THAT FORCEPS COULD NOT OPEN UP DURING VITRECTOMY SURGERY. PROCEDURE WAS COMPLETED WITH ANOTHER FORCEPS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23072037 ↗
• MalfunctionMay 21, 2025Difficult to Open or Close; Difficult to Open or Close

  A PHYSICIAN REPORTED THAT DURING VITRECTOMY SURGERY A TIP OF THE FORCEPS CANNOT BE OPENED WHEN PRESSING THE HANDLE. PATIENT IMPACT WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22060183 ↗
• MalfunctionFeb 5, 2025Activation Problem; Activation Problem

  A NURSE REPORTED THAT DURING VITRECTOMY SURGERY, AN OPHTHALMIC FORCEPS DID NOT WORK AND TIP DID NOT OPEN. THE FORCEPS REMAINED IN THE CLOSED POSITION. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING THE PRODUCT WITH ANOTHER ONE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21313305 ↗
• MalfunctionJan 17, 2025Difficult to Open or Close; Difficult to Open or Close

  A NURSE REPORTED THAT THE OPHTHALMIC FORCEPS WOULD NOT OPEN NORMALLY. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21176722 ↗
• MalfunctionDec 12, 2024Difficult to Open or Close; Difficult to Open or Close

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE SURGERY WAS COMPLETED BY REPLACING THE FORCEPS. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20913895 ↗
• MalfunctionNov 8, 2024Difficult to Open or Close; Difficult to Open or Close

  A CUSTOMER REPORTED THAT THE JAW OF AN OPHTHALMIC FORCEPS WOULD NOT OPEN. IT WAS NOTED THAT VITREORETINAL SURGERY WAS SCHEDULED, AND THERE WAS NO PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 20639684 ↗
• MalfunctionMar 1, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED THAT AN OPHTHALMIC FORCEPS TIPS STUCK TOGETHER AND IT COULD NOT MOVE DURING THE SURGERY. THE PROCEDURE WAS COMPLETED ON THE SAME DAY AND THERE WAS NO REPORT OF PATIENT HARM AND PROCEDURE DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18815080 ↗
• MalfunctionFeb 19, 2024Difficult to Open or Close; Difficult to Open or Close

  A NURSE REPORTED THAT OPHTHALMIC FORCEPS GOT STUCK DURING SURGERY. THE DETAILS OF PROCEDURE AND PATIENT HARM WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE. ADDITIONAL INFORMATION RECEIVED REPORTING THAT DURING VITRECTOMY SURGERY FORCEPS GOT STUCK. PROCEDURE WAS COMPLETED WITH ALTERNATIVE PRODUCT AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18729400 ↗
• MalfunctionJan 18, 2024Difficult to Open or Close; Difficult to Open or Close

  A CUSTOMER REPORTED THAT THEY FOUND THE TIP OF THE FORCEPS WAS NOT WORKING. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. UPON ADDITIONAL INFORMATION RECEIVED IT WAS REPORTED THAT THE FORCEPS WERE GETTING STUCK DURING VITRECTOMY SURGERY AND THE PROCEDURE WAS COMPLETED WITH THE HELP OF NEW FORCEPS AND THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18532476 ↗
• MalfunctionJan 2, 2024Difficult to Open or Close; Difficult to Open or Close

  A CUSTOMER REPORTED THAT DURING THE VITRECTOMY SURGERY OPHTHALMIC FORCEPS WAS USED AND IT WOULD NOT OPEN, WHICH GOT STUCK IN CLOSED POSITION. THE SURGERY WAS COMPLETED BY USING THE ALTERNATIVE FORCEPS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18424080 ↗
• MalfunctionSep 25, 2023Device Damaged by Another Device; Device Damaged by Another Device

  A GOVERNMENT AGENCY WAS REPORTED THAT AN OPHTHALMIC OPERATING FORCEPS ARE BROKEN BY THE HAPTICS DURING THE SURGERY. THERE WAS NO REPORT OF PROCEDURE AND PATIENT HARM DETAILS. ADDITIONAL INFORMATION AS BEEN REQUESTED AND NON E RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17806472 ↗
• 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 17727155 ↗
• 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 17727152 ↗
• 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. SUBSEQUENTLY 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 17727151 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED VIA A CLINICAL STUDY THAT DURING A VITRECTOMY/ CATARACT COMBINATION SURGERY WITH THE USE OF DISPOSABLE OPHTHALMIC PRODUCT A PATIENT EXPERIENCED RETINAL TEAR, DETACHMENT OF RETINA AND DECREASE IN VISUAL ACUITY. PATIENT WAS HOSPITALIZED AND INTERVENTION WAS GIVEN AND THE SYMPTOMS ARE STILL CONTINUING . NO FURTHER INFORMATION EXPECTED AS THE DETAILS WERE RECEIVED FROM A CLINICAL STUDY. THIS IS SEVEN OF ELEVEN REPORTS FOR THIS ISSUE AND REPRESENTS THE OPHTHALMIC FORCEPS.

  Patient problems: Retinal Detachment; Retinal Tear; Visual Impairment

  MAUDE report 17200008 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED VIA A CLINICAL STUDY THAT DURING A VITRECTOMY/ CATARACT COMBINATION SURGERY WITH THE USE OF DISPOSABLE OPHTHALMIC PRODUCT A FEMALE PATIENT EXPERIENCED RETINAL TEAR, DETACHMENT OF RETINA. PATIENT WAS HOSPITALIZED AND UNKNOWN INTERVENTION WAS GIVEN, THE SYMPTOMS ARE CONTINUING. NO FURTHER INFORMATION EXPECTED AS THE DETAILS WERE RECEIVED FROM A CLINICAL STUDY.

  Patient problems: Retinal Detachment; Retinal Tear

  MAUDE report 17198264 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED VIA A CLINICAL STUDY THAT DURING A VITRECTOMY/ CATARACT COMBINATION SURGERY BY USING DISPOSABLE OPHTHALMIC FORCEPS AND HANDPIECES A MALE PATIENT EXPERIENCED EPIRETINAL MEMBRANE RECURRENCE, VITREOUS HEMORRHAGE AND PROLIFERATIVE VITREORETINOPATHY. PATIENT WAS HOSPITALIZED AND UNKNOWN INTERVENTION WAS GIVEN.

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

  MAUDE report 17197862 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED VIA A CLINICAL STUDY THAT DURING A VITRECTOMY/ CATARACT COMBINATION SURGERY INCLUDING MEMBRANE PEELING AND REATTACHMENT OF RETINA TO IMPROVE CURRENT VISION WITH THE USE OF DISPOSABLE OPHTHALMIC PRODUCTS A PATIENT EXPERIENCED RETINAL TEAR, DETACHMENT OF RETINA AND DECREASE IN VISUAL ACUITY. PATIENT WAS HOSPITALIZED AND INTERVENTION WAS GIVEN AND THE SYMPTOMS WERE CONTINUING. NO FURTHER INFORMATION EXPECTED AS THE DETAILS WERE RECEIVED FROM A CLINICAL STUDY. THIS IS SEVENTH OF ELEVEN REPORTS FOR THIS EVENT AND REPRESENTS THE OPHTHALMIC FORCEPS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Retinal Detachment; Retinal Tear

  MAUDE report 17196871 ↗
• MalfunctionJun 15, 2023Difficult to Open or Close; Difficult to Open or Close

  A NURSE REPORTED THAT DURING A VITRECTOMY SURGERY AN OPHTHALMIC FORCEPS DID NOT WORK. SURGERY WAS COMPLETED BY AN ALTERNATE FORCEP. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17133560 ↗
• MalfunctionApr 21, 2023Break; Break

  A NURSE REPORTED THAT DURING PARS PLANA VITRECTOMY PROCEDURE, FORCEPS PIECE WAS DETACHED FROM THE HANDLE. PHYSICIAN SEARCHED THE INTRAOCULAR PORTION OF THE EYE BUT, THEY WERE UNABLE TO FIND THE FORCEPS. NO PATIENT HARM WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16783013 ↗
• MalfunctionApr 12, 2023Difficult to Open or Close; Difficult to Open or Close

  A HEALTHCARE PROFESSIONAL REPORTED THAT OPHTHALMIC FORCEPS CLAMPS WERE LOCKED WHEN STARTED AND CLOSED. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED NONE RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16724022 ↗
• MalfunctionApr 6, 2023Difficult to Open or Close; Difficult to Open or Close

  A CUSTOMER REPORTED THAT FORCEPS STUCK FULLY CLOSED DURING SURGERY, THE FORCEPS WAS REMOVED FROM PATIENT¿S EYE AND THE PROCEDURE WAS COMPLETED WITH A NEW FORCEPS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16688417 ↗
• MalfunctionMar 16, 2023Difficult to Open or Close; Difficult to Open or Close

  A CUSTOMER REPORTED THAT DURING THE VITRO RETINAL SURGERY OPHTHALMIC FORCEPS WAS STUCK IN THE CLOSED POSITION. SURGERY WAS COMPLETED WITH NEW FORCEPS ON THE SAME DAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16554532 ↗
• MalfunctionJan 24, 2023Difficult to Open or Close; Difficult to Open or Close

  A PHYSICIAN REPORTED THAT DURING VITRECTOMY PROCEDURE AFTER INSERTION OF OPHTHALMIC FORCEPS INTO THE EYE FROM THE TROCAR WITH THE TIP CLOSED, THE TIP OF FORCEPS DID NOT OPEN WHEN THE GRIP WAS LOOSENED TO OPEN IT. THE SURGERY WAS COMPLETED AFTER REPLACING THE OPHTHALMIC FORCEPS WITH ANOTHER ONE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16232426 ↗