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SHARKSKIN 711.88Recalls & reported problems

Alcon Laboratories, Inc. · 27+SHARKSKIN ILM FORCEPS DSP · Class 1

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07612717071551), received between Jun 30, 2022 and Jun 30, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Difficult to Open or Close3
  • Noise, Audible3

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 30, 2022Difficult to Open or Close; Noise, Audible; Difficult to Open or Close; Noise, Audible

    A PHYSICIAN REPORTED THAT DURING A VITRECTOMY PROCEDURE THREE OPHTHALMIC FORCEPS HAD MESHING FAILURE AND MADE A SQUEAKING NOISE WHEN OPENING AND CLOSING DURING INSERTION. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14876743 ↗
  • MalfunctionJun 30, 2022Difficult to Open or Close; Noise, Audible; Difficult to Open or Close; Noise, Audible

    A PHYSICIAN REPORTED THAT DURING A VITRECTOMY PROCEDURE THREE OPHTHALMIC FORCEPS HAD MESHING FAILURE AND MADE A SQUEAKING NOISE WHEN OPENING AND CLOSING DURING INSERTION. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14876704 ↗
  • MalfunctionJun 30, 2022Difficult to Open or Close; Noise, Audible; Difficult to Open or Close; Noise, Audible

    A PHYSICIAN REPORTED THAT DURING A VITRECTOMY PROCEDURE THREE OPHTHALMIC FORCEPS HAD MESHING FAILURE AND MADE A SQUEAKING NOISE WHEN OPENING AND CLOSING DURING INSERTION. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14876544 ↗

Other Forceps, ophthalmic devices

All Forceps, ophthalmic devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.