BAERVELDT GLAUCOMA IMPLANT (250) BG103250Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 05050474513013), received between Aug 18, 2017 and May 15, 2026 — classified as 4 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Complete Blockage; Device Difficult to Setup or Prepare

  THE FOLLOWING WAS REPORTED REGARDING THE JOHNSON (JNJ) GLAUCOMA SHUNT. THE SURGEON SAID THAT THE PRODUCT FEELS DIFFERENT AND ASKED IF THE MATERIAL HAD CHANGED. THE SURGEON RECENTLY SEVERED A SHUNT WHILE TYING WITH A SUTURE AND HAS NEVER HAD THIS HAPPEN BEFORE. WHAT THE SURGEON FOUND MOST CONCERNING IS THAT AFTER SHE TIED OFF THE TUBE, WHEN SHE THEN INJECTED BALANCE SALT SOLUTION (BSS) INTO THE TUBE, IT SWELLED UP, EXPANDED LIKE AN INNER TUBE. "THAT NEVER HAPPENED BEFORE". NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25194668 ↗
• MalfunctionNov 5, 2025Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT DURING A SURGICAL PROCEDURE, A GLAUCOMA SHUNT IMPLANT WAS IMPLANTED AND THEN IMMEDIATELY EXPLANTED DUE TO THE SURGEON IDENTIFYING A LEAK IN THE TUBING OF THE DEVICE. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE, AND NO HARM TO THE PATIENT WAS OBSERVED. THE DEVICE HAD POSITIVE PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23483207 ↗
• MalfunctionOct 20, 2025Break; Break

  IT WAS REPORTED THAT THE TUBE ON THE BAERVELDT SHUNT SPLIT DURING THREADING OR TYING OFF AFTER INSERTION. THE FULLY IMPLANTED SHUNT, WHICH CONTACTED THE PATIENT¿S LEFT EYE, WAS REPLACED WITH ANOTHER BAERVELDT SHUNT DURING THE SAME PROCEDURE TO COMPLETE THE OPERATION. THERE WAS NO PATIENT INJURY, AND NO UNPLANNED SUTURES WERE REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23342601 ↗
• MalfunctionMay 6, 2025Break; Break

  THE SIDE PART OF THE BG103-250 MODEL GLAUCOMA SHUNT SHEARED OFF AS THE DOCTOR WAS SUTURING THE SHUNT AS PER USUAL. THE SHUNT WAS REMOVED AND A NEW ONE WAS UTILIZED TO COMPLETE THE SAME PROCEDURE. THE SUSPECT SHUNT IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21973686 ↗
• InjuryAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE GLAUCOMA IMPLANT WAS REMOVED/EXPLANTED DUE TO PATIENT REPORTS OF PAIN AND HAVING ISSUES WITH IT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort; Eye Pain

  MAUDE report 19986779 ↗
• MalfunctionJul 10, 2024Break; Break

  IT WAS REPORTED THAT A GLAUCOMA SHUNT WAS REMOVED FROM THE PATIENT'S LEFT EYE DUE TO BROKEN SHUNT WHILE THE CUSTOMER WAS TRYING TO TIE THE TUBE. IT WAS NOTED THAT EVENT WAS DUE TO A PRODUCT ISSUE. THERE WAS PATIENT CONTACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE GLAUCOMA SHUNT WAS REPLACED WITH A DIFFERENT SHUNT. PROCEDURE WENT WELL. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES DONE. THE PATIENT IS DOING FINE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19715895 ↗
• MalfunctionDec 12, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT A GLAUCOMA IMPLANT WAS FULLY INSERTED INTO A PATIENT¿S LEFT EYE AND WOULD NOT FLUSH. THEREFORE, THE DOCTOR TOOK IT OUT AND REPLACED IT WITH A NEW SHUNT OF THE SAME MODEL. THE ISSUE WAS NOTICED AFTER INSERTION. NO SURGICAL AND/OR MEDICAL INTERVENTIONS REQUIRED. THE PATIENT IS DOING FINE AND NO INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18315584 ↗
• InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE GLAUCOMA IMPLANT WAS IMPLANTED ON (B)(6) 2021, IT WAS THEN REMOVED IN MAY 2022. THE PATIENT IS EXPERIENCING INFLAMMATION, IRRITATION, AND CONSTANT WATERING OF THE EYE. THE PATIENT BELIEVES THE BODY HAS REJECTED THE IMPLANT. THE PATIENT IS CURRENTLY UNDER TREATMENT WITH THE SAME IMPLANTING PHYSICIAN AND ON THE FOLLOWING MEDICATIONS: PREDNISONE FOR 3 DAYS; EORZOLAMIEEHCI ,TIMOLOLMALEATE; BROMFENAC SOLUTION. THE PATIENT REPORTED HAVING PERMANENT EYE AND OPTIC DAMAGE AND IS SUGGESTING THAT IT MIGHT BE THE IMPLANT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Excessive Tear Production; Eye Injury; Inflammation; Red Eye(s)

  MAUDE report 16401660 ↗
• MalfunctionNov 14, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT AN GLAUCOMA IMPLANT SHUNT THAT WOULD NOT FLUSH FOR THE SURGEON. THROUGH FOLLOW-UP, IT WAS LEARNED THERE WAS NO PATIENT CONTACT. THE SURGEON USED A DIFFERENT SHUNT FOR THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15788968 ↗
• MalfunctionJun 28, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE BAERVELDT SHUNT THAT WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) IN 2017 WILL BE REPOSITIONED ON (B)(6) 2022, TUBE SHUNT EXTENDER WAS ALSO REQUESTED FOR THE REPOSITIONING PROCEDURE. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED STATING THE TUBE SHUNT IS NOW TOUCHING PATIENT'S CORNEA AND MAY BE CAUSING HIS DESCEMET STRIPPING AUTOMATED ENDOTHELIAL KERATOPLASTY (DSAEK) GRAFT TO FAIL. PATIENT HAS TWO (02) FAILED DSAEK PROCEDURES AND CURRENTLY IS IN GRAFT REJECTION WITH CORNEAL EDEMA PRESENT IN HIS OS. ALSO, THE TUBE IS TOO SHORT AND NEEDS CORRECTING. IT WAS CONFIRMED THERE IS NO SERIOUS PATIENT INJURY. IT IS UNKNOWN IF THE TUBE SHUNT DISLOCATED AFTER INITIAL IMPLANT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Corneal Edema; Insufficient Information

  MAUDE report 14847635 ↗
• InjuryJun 9, 2021Complete Blockage; Complete Blockage

  THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: PRIMARY OUTCOMES OF BAERVELDT GLAUCOMA IMPLANTS WITH A MODIFIED TECHNIQUE TO CONTROL INTRAOCULAR PRESSURE IN DIFFERENT CASES OF GLAUCOMA. A RETROSPECTIVE COHORT STUDY WAS DONE TO DESCRIBE THE OUTCOMES OF BAERVELDT GLAUCOMA IMPLANTS (BGI; ABBOTT MEDICAL OPTICS) IMPLANTED VIA A MODIFIED TECHNIQUE WITH REGARD TO EARLY INTRAOCULAR PRESSURE (IOP) REDUCTION IN CASES OF UNCONTROLLED GLAUCOMA. A TOTAL OF 42 EYES OF 42 PATIENTS WITH GLAUCOMA UNDERWENT BGI IMPLANTATION WITH THE MODIFIED TECHNIQUE WITH OCCLUSION AND FENESTRATIONS OF THE TUBE. THIRTY-SEVEN (37) EYES WERE IMPLANTED WITH BGI 350 MM2 MODEL AND 5 EYES WERE IMPLANTED WITH BGI 250 MM2 MODEL. DURING THE PROCEDURE, A VICRYL 8.0 TRACTION TO THE SUPERIOR PERIPHERAL CORNEA AT 50% THICKNESS WAS PERFORMED THEN AFTER PARACENTESIS WITH A 15-DEGREE KNIFE, A VISCOELASTIC HEALON GV OVD (ABBOTT MEDICAL OPTICS INC.) WAS INJECTED INTO THE ANTERIOR CHAMBER. LASTLY, THREE DOUBLE PERFORATED CUTS WERE MADE IN THE TUBE WITH A SPATULATED NEEDLE, AND FENESTRATIONS WERE MADE WITH A VICRYL 7¿0 SUTURE, 1¿3 MM POSTERIOR TO THE SCLERAL NEEDLE TRACK THEN THE CONJUNCTIVA WAS FINALLY SUTUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11970628 ↗
• MalfunctionApr 24, 2021Break; Break

  IT WAS REPORTED THAT THE GLAUCOMA SHUNT WAS DEFECTIVE. THE TUBE SPLIT WHEN SUTURE WAS PUT THROUGH IT. THERE WAS PATIENT CONTACT. A NEW SHUNT WAS OPENED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING IT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11721535 ↗
• MalfunctionAug 20, 2020Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED BAERVELDT SHUNT WAS PARTIALLY IMPLANTED AND THEN REMOVED WHEN THE DOCTOR NOTED THE SHUNT HAD BLOCKAGE. THE PROCEDURE COMPLETED USING ANOTHER SHUNT. THERE WAS NO MEDICAL INTERVENTION REQUIRED. PATIENT OUTCOME WAS REPORTED AS FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10429494 ↗
• InjuryJan 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LACRIMAL GLAND IS SWELLING SINCE SURGERY BY PUTTING PRESSURE ON THE LEFT EYE CAUSING HEADACHES AND AFFECTING DAILY ACTIVITIES. SYMPTOMS STARTED TWO DAYS AFTER IMPLANTATION AS SHUNT WAS TOUCHING THE EYELID CAUSING IT TO SWELL. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Headache; Swelling

  MAUDE report 9639962 ↗
• MalfunctionFeb 22, 2019Product Quality Problem; Obstruction of Flow; Product Quality Problem; Obstruction of Flow

  IT WAS REPORTED THAT GLAUCOMA SHUNT DID NOT PRIME. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND FOUND TO BE OBSTRUCTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8364412 ↗
• MalfunctionAug 18, 2017Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT WHEN THE DOCTOR TRIED TO FLUSH THE SILICONE TUBE, IT WOULD NOT ADVANCE. THE EVENT OCCURRED DURING HANDLING/PRIOR TO INSERTION. THERE WAS NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Patient Involvement

  MAUDE report 6805842 ↗