VitreQ BF25.D02Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 88719214220910), received between Oct 29, 2025 and Jan 21, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2026Material Fragmentation; Detachment of Device or Device Component

  ON (B)(6) 2025, BVI VITREQ WAS INFORMED OF AN ISSUE CONCERNING OUR PRODUCT, BF25.D02. ACCORDING TO THE CUSTOMER, THE SILICONE TIP WAS FOUND TO BE MISSING PRIOR TO USE DURING THE PROCEDURE. AT THAT TIME, THE COMPLAINT WAS CONSIDERED NOT REPORTABLE, AND A PRODUCT RETURN WAS INITIATED. AFTER THE PRODUCT WAS RECEIVED AND EVALUATED, IT WAS CONCLUDED THAT, CONTRARY TO THE INITIAL ALLEGATION, THE BACKFLUSH WAS MOST LIKELY USED DURING SURGERY AND THAT THE TIP DETACHED AT SOME POINT DURING THE PROCEDURE. AS FAR AS BVI IS CURRENTLY AWARE, THERE WAS NO PATIENT IMPACT. THE MOST LIKELY SCENARIO IS THAT THE SURGEON IMMEDIATELY NOTICED THAT THE TIP HAD DETACHED AND REMOVED THE TIP REMNANTS FROM THE EYE AS PART OF THE ONGOING PROCEDURE. ALTHOUGH NONE OF THE INFORMATION RECEIVED TO DATE INDICATES THAT HARM OCCURRED, THE FAILURE MODE HAS THE POTENTIAL TO CAUSE SERIOUS INJURY IF IT RECURS. THEREFORE, THE EVENT IS CONSIDERED REPORTABLE TO THE COMPETENT AUTHORITIES AS A DEVICE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24129935 ↗
• MalfunctionJan 2, 2026Material Fragmentation; Detachment of Device or Device Component

  ON DECEMBER 8, 2025, BVI VITREQ WAS INFORMED OF AN ISSUE CONCERNING OUR PRODUCT, BF25.D02. ACCORDING TO THE CUSTOMER, THE SILICONE TIP WAS FOUND TO BE MISSING PRIOR TO USE DURING THE PROCEDURE. AT THAT TIME, THE COMPLAINT WAS CONSIDERED NOT REPORTABLE, AND A PRODUCT RETURN WAS INITIATED. AFTER THE PRODUCT WAS RECEIVED AND EVALUATED, IT WAS CONCLUDED THAT, CONTRARY TO THE INITIAL ALLEGATION, THE BACKFLUSH WAS MOST LIKELY USED DURING SURGERY AND THAT THE TIP DETACHED AT SOME POINT DURING THE PROCEDURE. AS FAR AS BVI IS CURRENTLY AWARE, THERE WAS NO PATIENT IMPACT. THE MOST LIKELY SCENARIO IS THAT THE SURGEON IMMEDIATELY NOTICED THAT THE TIP HAD DETACHED AND REMOVED THE TIP REMNANTS FROM THE EYE AS PART OF THE ONGOING PROCEDURE. ALTHOUGH NONE OF THE INFORMATION RECEIVED TO DATE INDICATES THAT HARM OCCURRED, THE FAILURE MODE HAS THE POTENTIAL TO CAUSE SERIOUS INJURY IF IT RECURS. THEREFORE, THE EVENT IS CONSIDERED REPORTABLE TO THE COMPETENT AUTHORITIES AS A DEVICE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23942628 ↗
• MalfunctionNov 7, 2025Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  ON (B)(6) 2025, BVI VITREQ WAS INFORMED ABOUT AN ISSUE CONCERNING OUR PRODUCT, BF25.D02. AS STATED BY THE CUSTOMER, AND VOLUNTARILY REPORTED TO THE ANSM, DURING INSERTION INTO THE VITRECTOMY TROCAR, THE SILICONE TIP DETACHED INSIDE THE EYE. OF THE THREE UNITS USED DURING TWO SEPARATE PROCEDURES (SAME BATCH NUMBER), TWO EXHIBITED THE SAME ISSUE. THE INCIDENT RESULTED IN A PROLONGATION OF THE OPERATING TIME. ADDITIONALLY, THE CUSTOMER EXPRESSED CONCERN ABOUT A POTENTIAL RISK OF LEAVING A PIECE OF TRANSPARENT SILICONE INSIDE THE EYE IF IT GOES UNNOTICED BY THE SURGEON. THE RISK RELATED TO DETACHMENT OF A SILICONE TIP FOR A BACKFLUSH DEVICE IS COVERED IN OUR RISK MANAGEMENT FILES. THE OTHER PROCEDURE IS REPORTED UNDER A SEPARATE EMDR REPORT #3012037425-2025-00003.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23498475 ↗
• MalfunctionNov 7, 2025Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  ON OCTOBER 16TH, 2025, BVI VITREQ WAS INFORMED ABOUT AN ISSUE CONCERNING OUR PRODUCT, BF25.D02. AS STATED BY THE CUSTOMER, AND VOLUNTARILY REPORTED TO THE ANSM, DURING INSERTION INTO THE VITRECTOMY TROCAR, THE SILICONE TIP DETACHED INSIDE THE EYE. OF THE THREE UNITS USED DURING TWO SEPARATE PROCEDURES (SAME BATCH NUMBER), TWO EXHIBITED THE SAME ISSUE. THE INCIDENT RESULTED IN A PROLONGATION OF THE OPERATING TIME. ADDITIONALLY, THE CUSTOMER EXPRESSED CONCERN ABOUT A POTENTIAL RISK OF LEAVING A PIECE OF TRANSPARENT SILICONE INSIDE THE EYE IF IT GOES UNNOTICED BY THE SURGEON. THE RISK RELATED TO DETACHMENT OF A SILICONE TIP FOR A BACKFLUSH DEVICE IS COVERED IN OUR RISK MANAGEMENT FILES. THE OTHER PROCEDURE IS REPORTED UNDER A SEPARATE EMDR REPORT #3012037425-2025-00004.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23498456 ↗
• MalfunctionOct 29, 2025Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  ON (B)(6) 2025, WE WERE NOTIFIED THAT THE "DEVICE WAS CLOGGED FROM THE BEGINNING OF USE AND COULD NOT BE USED" FOR A BF25.D02 BACKFLUSH DEVICE. HOWEVER, DURING RETURNED DEVICE INVESTIGATION IT WAS FOUND THAT THE SILICONE TIP WAS CUT OFF. HOSPITAL WAS CONTACTED TO REQUEST FOLLOW-UP INFORMATION FOR THE DEVICE WHERE THE TIP CAME OFF. AS FAR AS BVI IS CURRENTLY AWARE THERE IS NO PATIENT IMPACT, THE MOST LIKELY SCENARIO IS THAT THE SURGEON IMMEDIATELY NOTICED THAT THE TIP CAME OFF AND HAD REMOVED THE TIP REMAINS FROM THE EYE AS PART OF THE ONGOING PROCEDURE. ALTHOUGH NONE OF THE INFORMATION RECEIVED TO DATE POINT THAT HARM OCCURRED, THE FAILURE MODE HAS THE POTENTIAL TO CAUSE SERIOUS INJURY IF IT RECURS. THEREFORE, THE EVENT IS CONSIDERED REPORTABLE TO THE COMPETENT AUTHORITIES AS A DEVICE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23412591 ↗
• MalfunctionOct 29, 2025Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  ON 01OCT2025, WE WERE NOTIFIED THAT THE "TIP CAME OFF DURING USE IN SURGERY" FOR A BF25.D02 BACKFLUSH DEVICE. HOSPITAL WAS CONTACTED TO REQUEST FOLLOW-UP INFORMATION FOR THE DEVICE WHERE THE TIP CAME OFF. AS FAR AS BVI IS CURRENTLY AWARE THERE IS NO PATIENT IMPACT, THE MOST LIKELY SCENARIO IS THAT THE SURGEON IMMEDIATELY NOTICED THAT THE TIP CAME OFF AND HAD REMOVED THE TIP REMAINS FROM THE EYE AS PART OF THE ONGOING PROCEDURE. ALTHOUGH NONE OF THE INFORMATION RECEIVED TO DATE POINT THAT HARM OCCURRED, THE FAILURE MODE HAS THE POTENTIAL TO CAUSE SERIOUS INJURY IF IT RECURS. THEREFORE, THE EVENT IS CONSIDERED REPORTABLE TO THE COMPETENT AUTHORITIES AS A DEVICE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23411510 ↗