BAERVELDT GLAUCOMA IMPLANT (350) BG101350Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 05050474512993), received between Sep 1, 2016 and Mar 30, 2026 — classified as 13 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A BOX OF A GLAUCOMA SHUNT WAS SLICED OPEN ON ONE END AND WAS SQUISHED ON THE OTHER END OF BOX. THE UPS BOX WAS INTACT BUT THE INNER BOX WAS DAMAGED. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE OUTER SHIPPING BOX WAS NOT DAMAGED; HOWEVER, THE DEVICE BOX INSIDE WAS SQUISHED ON ONE END AND THE SEAL ON THE OTHER END WAS OPEN. THE STERILITY OF THE DEVICE WAS POTENTIALLY COMPROMISED AS THE SEAL ON THE DEVICE LID WAS OPENED. THE OUTER BOX CONTAINED PAPER AS VOID FILL ALONG WITH THE PACKING SLIP, AND NO ADDITIONAL PROTECTIVE MATERIALS WERE NOTED. NO PICTURES OF THE DEVICE BOX OR SHIPPING BOX ARE AVAILABLE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24710314 ↗
• MalfunctionFeb 2, 2026Break

  A TEAR IN THE TUBING OF THE BG101-350 IMPLANT LEADING TO THE INTERIOR CHAMBER WAS OBSERVED AFTER ITS IMPLANTATION IN THE PATIENT'S OCULAR DEXTER (RIGHT EYE). THERE WAS NO SERIOUS PATIENT INJURY AND NO SUTURES DURING THE PROCEDURE. PATIENT PROGNOSIS POST-PROCEDURE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24230998 ↗
• MalfunctionApr 17, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) GLAUCOMA IMPLANT WAS NOT FLUSHING PROPERLY. THE DOCTOR SYSTEMATICALLY CHECKS EACH BAERVELDT IMPLANT TO ENSURE THEY FLUSH PROPERLY BEFORE IMPLANTATION, BUT THIS PARTICULAR IMPLANT FAILED THE TEST. IT SEEMS THE SHUNT WAS OCCLUDED. THE DOCTOR FLUSHES OR ATTEMPTS TO FLUSH THE BAERVELDT SHUNT ON THE STERILE FIELD. IF IT DOES NOT FLUSH IT DOES NOT TOUCH THE EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21859515 ↗
• MalfunctionJan 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IN A CLINICAL STUDY CASE, A PATIENT UNDERWENT CATARACT/CLEAR LENS EXCHANGE AND GLAUCOMA SURGERY ON THE RIGHT EYE (OD). SUBSEQUENT POSTOPERATIVE VISITS REVEALED OCULAR FINDINGS. NO SURGICAL COMPLICATIONS, NO OTHER SURGICAL INTERVENTIONS REPORTED DURING THE INITIAL SURGERY. ON (B)(6) 2022, 1-WEEK POST-OP CATARACT SURGERY, ANTERIOR CHAMBER CELLS IN OD WERE NOTED. ON (B)(6) 2023, 6-MONTHS POST-OP CATARACT SURGERY, POSTERIOR CAPSULE OPACIFICATION (PCO) IN OD WAS NOTICED. SUTURE REMOVAL WAS INDICATED AS WELL. ON (B)(6) 2024, 12-MONTHS POST-OP CATARACT SURGERY, POSTERIOR CAPSULE OPACIFICATION (PCO) IN OD REPORTED WHICH REQUIRED A YTTRIUM-ALUMINUM-GARNET (YAG) LASER CAPSULOTOMY PROCEDURE ON (B)(6) 2024. THE STUDY ALSO REPORTED THAT A SECONDARY SURGICAL INTERVENTION AFTER GLAUCOMA SURGERY REQUIRED, WITH THE MODERATE SEVERITY WHICH THE GLAUCOMA TUBE NEEDED TRIMMING, ITS TIP SOMETIMES TOUCHED THE CORNEA. THE PRE-OP COMMENTS MENTIONED "TUBE WELL POSITIONED, NOT TOUCHING CORNEA CENTRALLY AT REST BUT ENDOTHELIAL OPACITY INDICATES TIP IS SOMETIMES TOUCHING CORNEA. PROBABLY WITH EYE RUBBING OR OTHER MOVEMENT. NEEDS TRIM." IT WAS NOTED THAT THE DEVICE IS BELIEVED TO HAVE ATTRIBUTED TO THE REPORTED

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

  MAUDE report 21132309 ↗
• InjuryNov 10, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED IN A RETROSPECTIVE UNMASKED STUDY DONE THAT A GLAUCOMA SHUNT WAS IMPLANTED IN A PATIENT'S LEFT EYE DUE TO PRE-EXISTING GLAUCOMA. IT WAS LEARNED THAT ONE DAY AFTER IMPLANTATION OF THE SHUNT, HYPHEMA WAS DIAGNOSED AND REPORTED BY THE SITE TO BE A DEVICE AND PROCEDURE RELATED (BAERVELDT GLAUCOMA SHUNT SURGERY). THE SUBJECT ALSO COMPLAINED OF BLURRY VISION FOR 1 WEEK VISIT. SITE DID NOT MENTION ANY MEDICATION BUT HYPHEMA CAN RECOVER BY ITSELF BY LETTING THE PATIENT REST. NO CHANGE IN INTRAOCULAR PRESSURE (IOP) DUE TO HYPHEMA. THE SHUNT REMAINS IMPLANTED. NO EXCHANGE. THERE WAS NO DELAY IN PROCEDURE AND NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES DONE. NO OTHER ADVERSE EVENTS. SUBJECT FULLY RECOVERED FROM HYPHEMA AND BLURRED VISION WITHIN 36 DAYS, IOP IS STABILIZED WITHOUT SEQUELAE. THE INTRAOCULAR PRESSURE PREOP: 25 MMHG; 1 DAY POSTOP: 3MMHG; 1 WEEK POSTOP: 6 MMHG; 6 MONTH POSTOP: 13 MMHG; 12 MONTH POSTOP: 12 MMHG. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Hyphema

  MAUDE report 20649353 ↗
• MalfunctionNov 3, 2024Complete Blockage; Complete Blockage

  DURING DEVICE HANDLING AND PRIOR TO INSERTION, THE DOCTOR TRIED TO TIE THE TUBE OF THE BG101-350 MODEL GLAUCOMA IMPLANT OFF SEVERAL TIMES AND IT WOULD NOT OCCLUDE. THERE WAS NO PATIENT CONTACT/NO PATIENT INVOLVEMENT WITH THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20595625 ↗
• MalfunctionJun 3, 2024Break; Device Difficult to Setup or Prepare; Appropriate Device Problem Term/Code Not Available; Break; Device Difficult to Setup or Prepare; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SILICONE TUBING IN BAERVELDT GLAUCOMA SHUNT IS MORE WEAK RECENTLY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SURGEON IS STILL NOTICING THE DEVICE HAS CHANGED AND INDICATED THAT THE TUBING IS MORE FLIMSY. THE SURGEON HAS TROUBLE INSERTING IN THE SCLERA TUNNEL. IT WAS ALSO REPORTED THAT THE IMPLANT WAS FULLY INSERTED. IN ADDITION, BECAUSE THE TUBING IS FLIMSIER, IT HAS A TENDENCY TO KINK. WHEN THE SURGEON SUTURES THE TUBING, BECAUSE IT IS SO FRAGILE, THE SUTURE WILL CUT THE TUBING WHICH IS NOT NORMAL. LASTLY, IT WAS REPORTED THAT AFTER THE SURGEON SUTURED SOME OF THE TUBING'S TO FIXATE IT, WHEN THEY PERFORM THE FLUSHING TEST, IT LEAKS FROM THE MICRO HOLES IN THE TUBING. PATIENT STATUS REPORTED AS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR 5 OF THE 5 REPORTED EVENTS. A SEPARATE REPORT IS BEING SUBMITTED FOR EACH OF THE 5 PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19455476 ↗
• MalfunctionJun 3, 2024Break; Device Difficult to Setup or Prepare; Appropriate Device Problem Term/Code Not Available; Break; Device Difficult to Setup or Prepare; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SILICONE TUBING IN BAERVELDT GLAUCOMA SHUNT IS MORE WEAK RECENTLY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SURGEON IS STILL NOTICING THE DEVICE HAS CHANGED AND INDICATED THAT THE TUBING IS MORE FLIMSY. THE SURGEON HAS TROUBLE INSERTING IN THE SCLERA TUNNEL. IT WAS ALSO REPORTED THAT THE IMPLANT WAS FULLY INSERTED. IN ADDITION, BECAUSE THE TUBING IS FLIMSIER, IT HAS A TENDENCY TO KINK. WHEN THE SURGEON SUTURES THE TUBING, BECAUSE IT IS SO FRAGILE, THE SUTURE WILL CUT THE TUBING WHICH IS NOT NORMAL. LASTLY, IT WAS REPORTED THAT AFTER THE SURGEON SUTURED SOME OF THE TUBING'S TO FIXATE IT, WHEN THEY PERFORM THE FLUSHING TEST, IT LEAKS FROM THE MICRO HOLES IN THE TUBING. PATIENT STATUS REPORTED AS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR 4 OF THE 5 REPORTED EVENTS. A SEPARATE REPORT IS BEING SUBMITTED FOR EACH OF THE 5 PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19455461 ↗
• MalfunctionJun 3, 2024Break; Device Difficult to Setup or Prepare; Appropriate Device Problem Term/Code Not Available; Break; Device Difficult to Setup or Prepare; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SILICONE TUBING IN BAERVELDT GLAUCOMA SHUNT IS MORE WEAK RECENTLY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SURGEON IS STILL NOTICING THE DEVICE HAS CHANGED AND INDICATED THAT THE TUBING IS MORE FLIMSY. THE SURGEON HAS TROUBLE INSERTING IN THE SCLERA TUNNEL. IT WAS ALSO REPORTED THAT THE IMPLANT WAS FULLY INSERTED. IN ADDITION, BECAUSE THE TUBING IS FLIMSIER, IT HAS A TENDENCY TO KINK. WHEN THE SURGEON SUTURES THE TUBING, BECAUSE IT IS SO FRAGILE, THE SUTURE WILL CUT THE TUBING WHICH IS NOT NORMAL. LASTLY, IT WAS REPORTED THAT AFTER THE SURGEON SUTURED SOME OF THE TUBING'S TO FIXATE IT, WHEN THEY PERFORM THE FLUSHING TEST, IT LEAKS FROM THE MICRO HOLES IN THE TUBING. PATIENT STATUS REPORTED AS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR 3 OF THE 5 REPORTED EVENTS. A SEPARATE REPORT IS BEING SUBMITTED FOR EACH OF THE 5 PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19455110 ↗
• MalfunctionJun 3, 2024Break; Device Difficult to Setup or Prepare; Appropriate Device Problem Term/Code Not Available; Break; Device Difficult to Setup or Prepare; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SILICONE TUBING IN BAERVELDT GLAUCOMA SHUNT IS MORE WEAK RECENTLY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SURGEON IS STILL NOTICING THE DEVICE HAS CHANGED AND INDICATED THAT THE TUBING IS MORE FLIMSY. THE SURGEON HAS TROUBLE INSERTING IN THE SCLERA TUNNEL. IT WAS ALSO REPORTED THAT THE IMPLANT WAS FULLY INSERTED. IN ADDITION, BECAUSE THE TUBING IS FLIMSIER, IT HAS A TENDENCY TO KINK. WHEN THE SURGEON SUTURES THE TUBING, BECAUSE IT IS SO FRAGILE, THE SUTURE WILL CUT THE TUBING WHICH IS NOT NORMAL. LASTLY, IT WAS REPORTED THAT AFTER THE SURGEON SUTURED SOME OF THE TUBING'S TO FIXATE IT, WHEN THEY PERFORM THE FLUSHING TEST, IT LEAKS FROM THE MICRO HOLES IN THE TUBING. PATIENT STATUS REPORTED AS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR 2 OF THE 5 REPORTED EVENTS. A SEPARATE REPORT IS BEING SUBMITTED FOR EACH OF THE 5 PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19454933 ↗
• MalfunctionJun 3, 2024Break; Break

  IT WAS REPORTED THAT THE TUBE OF THE BAERVELDT GLAUCOMA IMPLANT BROKE, CAME OFF COMPLETELY WHEN THEY TRIED TO INSERT IT. IT WAS CLARIFIED THAT THERE WAS NO LOOSE PIECES/PARTICLES. THAT WHEN THE DOCTOR WAS TRYING TO MANIPULATE THE SHUT, IT BROKE, IT WAS CONNECTED, DID NOT NOT BREAK INTO PIECES AND DID NOT FALL INTO THE PATIENT'S EYE. THE DOCTOR HAD SUTURED THE SHUNT TO SCLERA AND HAD TO REMOVE THE SUTURES IN ORDER TO REMOVE THE DEVICE. ANOTHER SHUNT OF THE SAME MODEL SUCCESSFULLY IMPLANTED. ALL OF THIS WAS ON THE SAME DAY. THERE WAS NO INTERVENTIONS AND NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19453947 ↗
• MalfunctionJun 3, 2024Break; Device Difficult to Setup or Prepare; Appropriate Device Problem Term/Code Not Available; Break; Device Difficult to Setup or Prepare; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SILICONE TUBING IN BAERVELDT GLAUCOMA SHUNT IS MORE WEAK RECENTLY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SURGEON IS STILL NOTICING THE DEVICE HAS CHANGED AND INDICATED THAT THE TUBING IS MORE FLIMSY. THE SURGEON HAS TROUBLE INSERTING IN THE SCLERA TUNNEL. IT WAS ALSO REPORTED THAT THE IMPLANT WAS FULLY INSERTED. IN ADDITION, BECAUSE THE TUBING IS FLIMSIER, IT HAS A TENDENCY TO KINK. WHEN THE SURGEON SUTURES THE TUBING, BECAUSE IT IS SO FRAGILE, THE SUTURE WILL CUT THE TUBING WHICH IS NOT NORMAL. LASTLY, IT WAS REPORTED THAT AFTER THE SURGEON SUTURED SOME OF THE TUBING'S TO FIXATE IT, WHEN THEY PERFORM THE FLUSHING TEST, IT LEAKS FROM THE MICRO HOLES IN THE TUBING. PATIENT STATUS REPORTED AS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR 1 OF THE 5 REPORTED EVENTS. A SEPARATE REPORT IS BEING SUBMITTED FOR EACH OF THE 5 PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19451520 ↗
• MalfunctionJun 1, 2024Break; Device Difficult to Setup or Prepare; Appropriate Device Problem Term/Code Not Available; Break; Device Difficult to Setup or Prepare; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SILICONE TUBING IN BAERVELDT GLAUCOMA SHUNT IS MORE WEAK RECENTLY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SURGEON IS STILL NOTICING THE DEVICE HAS CHANGED AND INDICATED THAT THE TUBING IS MORE FLIMSY. THE SURGEON HAS TROUBLE INSERTING IN THE SCLERA TUNNEL. IT WAS ALSO REPORTED THAT THE IMPLANT WAS FULLY INSERTED. IN ADDITION, BECAUSE THE TUBING IS FLIMSIER, IT HAS A TENDENCY TO KINK. WHEN THE SURGEON SUTURES THE TUBING, BECAUSE IT IS SO FRAGILE, THE SUTURE WILL CUT THE TUBING WHICH IS NOT NORMAL. LASTLY, IT WAS REPORTED THAT AFTER THE SURGEON SUTURED SOME OF THE TUBING'S TO FIXATE IT, WHEN THEY PERFORM THE FLUSHING TEST, IT LEAKS FROM THE MICRO HOLES IN THE TUBING. PATIENT STATUS REPORTED AS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR 4 OF THE 5 REPORTED EVENTS. A SEPARATE REPORT IS BEING SUBMITTED FOR EACH OF THE 5 PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19443231 ↗
• MalfunctionJun 1, 2024Break; Device Difficult to Setup or Prepare; Appropriate Device Problem Term/Code Not Available; Break; Device Difficult to Setup or Prepare; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SILICONE TUBING IN BAERVELDT GLAUCOMA SHUNT IS MORE WEAK RECENTLY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SURGEON IS STILL NOTICING THE DEVICE HAS CHANGED AND INDICATED THAT THE TUBING IS MORE FLIMSY. THE SURGEON HAS TROUBLE INSERTING IN THE SCLERA TUNNEL. IT WAS ALSO REPORTED THAT THE IMPLANT WAS FULLY INSERTED. IN ADDITION, BECAUSE THE TUBING IS FLIMSIER, IT HAS A TENDENCY TO KINK. WHEN THE SURGEON SUTURES THE TUBING, BECAUSE IT IS SO FRAGILE, THE SUTURE WILL CUT THE TUBING WHICH IS NOT NORMAL. LASTLY, IT WAS REPORTED THAT AFTER THE SURGEON SUTURED SOME OF THE TUBING'S TO FIXATE IT, WHEN THEY PERFORM THE FLUSHING TEST, IT LEAKS FROM THE MICRO HOLES IN THE TUBING. PATIENT STATUS REPORTED AS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR 3 OF THE 5 REPORTED EVENTS. A SEPARATE REPORT IS BEING SUBMITTED FOR EACH OF THE 5 PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19443085 ↗
• MalfunctionJun 1, 2024Break; Device Difficult to Setup or Prepare; Appropriate Device Problem Term/Code Not Available; Break; Device Difficult to Setup or Prepare; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SILICONE TUBING IN BAERVELDT GLAUCOMA SHUNT IS MORE WEAK RECENTLY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SURGEON IS STILL NOTICING THE DEVICE HAS CHANGED AND INDICATED THAT THE TUBING IS MORE FLIMSY. THE SURGEON HAS TROUBLE INSERTING IN THE SCLERA TUNNEL. IT WAS ALSO REPORTED THAT THE IMPLANT WAS FULLY INSERTED. IN ADDITION, BECAUSE THE TUBING IS FLIMSIER, IT HAS A TENDENCY TO KINK. WHEN THE SURGEON SUTURES THE TUBING, BECAUSE IT IS SO FRAGILE, THE SUTURE WILL CUT THE TUBING WHICH IS NOT NORMAL. LASTLY, IT WAS REPORTED THAT AFTER THE SURGEON SUTURED SOME OF THE TUBING'S TO FIXATE IT, WHEN THEY PERFORM THE FLUSHING TEST, IT LEAKS FROM THE MICRO HOLES IN THE TUBING. PATIENT STATUS REPORTED AS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR 5 OF THE 5 REPORTED EVENTS. A SEPARATE REPORT IS BEING SUBMITTED FOR EACH OF THE 5 PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19443033 ↗
• MalfunctionJun 1, 2024Break; Device Difficult to Setup or Prepare; Appropriate Device Problem Term/Code Not Available; Break; Device Difficult to Setup or Prepare; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SILICONE TUBING IN BAERVELDT GLAUCOMA SHUNT IS MORE WEAK RECENTLY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SURGEON IS STILL NOTICING THE DEVICE HAS CHANGED AND INDICATED THAT THE TUBING IS MORE FLIMSY. THE SURGEON HAS TROUBLE INSERTING IN THE SCLERA TUNNEL. IT WAS ALSO REPORTED THAT THE IMPLANT WAS FULLY INSERTED. IN ADDITION, BECAUSE THE TUBING IS FLIMSIER, IT HAS A TENDENCY TO KINK. WHEN THE SURGEON SUTURES THE TUBING, BECAUSE IT IS SO FRAGILE, THE SUTURE WILL CUT THE TUBING WHICH IS NOT NORMAL. LASTLY, IT WAS REPORTED THAT AFTER THE SURGEON SUTURED SOME OF THE TUBING'S TO FIXATE IT, WHEN THEY PERFORM THE FLUSHING TEST, IT LEAKS FROM THE MICRO HOLES IN THE TUBING. PATIENT STATUS REPORTED AS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR 2 OF THE 5 REPORTED EVENTS. A SEPARATE REPORT IS BEING SUBMITTED FOR EACH OF THE 5 PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19443017 ↗
• MalfunctionJun 1, 2024Break; Device Difficult to Setup or Prepare; Appropriate Device Problem Term/Code Not Available; Break; Device Difficult to Setup or Prepare; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE SILICONE TUBING IN BAERVELDT GLAUCOMA SHUNT IS MORE WEAK RECENTLY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SURGEON IS STILL NOTICING THE DEVICE HAS CHANGED AND INDICATED THAT THE TUBING IS MORE FLIMSY. THE SURGEON HAS TROUBLE INSERTING IN THE SCLERA TUNNEL. IT WAS ALSO REPORTED THAT THE IMPLANT WAS FULLY INSERTED. IN ADDITION, BECAUSE THE TUBING IS FLIMSIER, IT HAS A TENDENCY TO KINK. WHEN THE SURGEON SUTURES THE TUBING, BECAUSE IT IS SO FRAGILE, THE SUTURE WILL CUT THE TUBING WHICH IS NOT NORMAL. LASTLY, IT WAS REPORTED THAT AFTER THE SURGEON SUTURED SOME OF THE TUBING'S TO FIXATE IT, WHEN THEY PERFORM THE FLUSHING TEST, IT LEAKS FROM THE MICRO HOLES IN THE TUBING. PATIENT STATUS REPORTED AS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR 1 OF THE 5 REPORTED EVENTS. A SEPARATE REPORT IS BEING SUBMITTED FOR EACH OF THE 5 PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19442956 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE BG101-350 MODEL GLAUCOMA IMPLANT WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE) TO ADDRESS HIGH EYE PRESSURE. THE PATIENT REPORTED FLUCTUATIONS IN EYE PRESSURE AND EXPERIENCED EXCESSIVE WATERY EYES. THE PATIENT REPORTED THE FOLLOWING EVENTS WITH THE EYES. GLAUCOMA SURGERY RESULTING IN TWO INTRAOCULAR LENS (IOL) IMPLANTS AND HAD LASER SURGERY. THE PATIENT REPORTED NO ISSUES WITH THE PRODUCT. THE PATIENT IS DISABLED FROM AN UNRELATED HEALTH ISSUE (POOR BACK AND ROTATOR CUFF). THE SHUNTS WERE PUT IN DUE TO VERY LOW PRESSURE; 1% IN LEFT EYE AND 5% IN THE RIGHT. THE PATIENT WAS PRESCRIBED FOUR ANTIBIOTICS. THE PATIENT STATED THAT THE EYES WERE WATERING SO MUCH THAT THE PATIENT STOPPED TAKING THE MEDICATION AND ENDED UP WITH EYE PRESSURE OF 40. THE DOCTOR REMOVED "RIP CORDS" FROM THE SHUNTS AND MENTIONED THAT THE PATIENT MAY NEED ADDITIONAL SUTURES. ON MONDAY (UNSPECIFIED DATE), THE PATIENT WENT TO SEE THE DOCTOR BECAUSE THE EYES STAYED DILATED AND MADE THE PATIENT FEEL SICK. THE DOCTOR REMOVED THE RIP CORDS AND DISCOVERED ULCERS IN THE RIGHT EYE. IN ADDITION, THERE WAS AN ISSUE THAT REQUIRED THREE TRIES TO REMOVE THE RIP CORDS. THE PATIENT REPORTED

  Patient problems: Blurred Vision; Excessive Tear Production; Unspecified Eye / Vision Problem

  MAUDE report 19217956 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE BG101-350 MODEL GLAUCOMA IMPLANT WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) TO ADDRESS HIGH EYE PRESSURE. THE PATIENT REPORTED FLUCTUATIONS IN EYE PRESSURE AND EXPERIENCED EXCESSIVE WATERY EYES. THE PATIENT REPORTED THE FOLLOWING EVENTS WITH THE EYES. GLAUCOMA SURGERY RESULTING IN TWO INTRAOCULAR LENS (IOL) IMPLANTS AND HAD LASER SURGERY. THE PATIENT REPORTED NO ISSUES WITH THE PRODUCT. THE PATIENT IS DISABLED FROM AN UNRELATED HEALTH ISSUE (POOR BACK AND ROTATOR CUFF). THE SHUNTS WERE PUT IN DUE TO VERY LOW PRESSURE; 1% IN LEFT EYE AND 5% IN THE RIGHT. THE PATIENT WAS PRESCRIBED FOUR ANTIBIOTICS. THE PATIENT STATED THAT THE EYES WERE WATERING SO MUCH THAT THE PATIENT STOPPED TAKING THE MEDICATION AND ENDED UP WITH EYE PRESSURE OF 40. THE DOCTOR REMOVED "RIP CORDS" FROM THE SHUNTS AND MENTIONED THAT THE PATIENT MAY NEED ADDITIONAL SUTURES. ON MONDAY (UNSPECIFIED DATE), THE PATIENT WENT TO SEE THE DOCTOR BECAUSE THE EYES STAYED DILATED AND MADE THE PATIENT FEEL SICK. THE DOCTOR REMOVED THE RIP CORDS AND DISCOVERED ULCERS IN THE RIGHT EYE. IN ADDITION, THERE WAS AN ISSUE THAT REQUIRED THREE TRIES TO REMOVE THE RIP CORDS. THE PATIENT REPORTED T

  Patient problems: Blurred Vision; Corneal Ulcer; Excessive Tear Production; Unspecified Eye / Vision Problem

  MAUDE report 19217953 ↗
• MalfunctionApr 4, 2024Break; Break

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON(JNJ) GLAUCOMA IMPLANT WAS DAMAGED. THE DOCTOR NOTICED TUBBING AND DID NOT LIKE THE WAY IT LOOKED. THE ISSUE WAS NOTICED AFTER THE DEVICE WAS INSERTED, TOUCHED THE PATIENT. THERE WERE NO IOL ISSUES. ANOTHER SHUNT OF THE SAME MODEL WAS IMPLANTED. SUTURES WERE USED, UNKNOWN HOW MANY. THERE WERE NO OTHER COMPLICATIONS AND NO PATIENT INJURY. THE PATIENT OUTCOME WAS REPORTED AS ¿GOOD¿. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19047197 ↗
• InjuryNov 21, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A GLAUCOMA IMPLANT SHUNT WAS EXPLANTED FROM THE PATIENT'S LEFT EYE. LOTS OF FENESTRATIONS OF THE TUBE, FLAT ANTERIOR CHAMBER AND PERSISTENT HYPOTONY WITH LEAKAGE AROUND THE TUBE NOTED. THE EYE WAS EXAMINED, AND IT WAS NOTED TO BE SEIDEL POSITIVE AROUND THE WOUND SITES WITH A BLEB FORMING OVER THE BAERVELDT TUBE. THE ANTERIOR CHAMBER WAS FILLED WITH COHESIVE VISCOELASTIC. THE PATIENT WAS FOLLOWED UP THE NEXT DAY. HE CONTINUED TO HAVE A FLATTENED ANTERIOR CHAMBER AND WAS EXPERIENCING DISCOMFORT. THE RISKS AND BENEFITS WERE DISCUSSED WITH THE PATIENT AND THE DECISION WAS MADE TO DO A TUBE REVISION FOR THE BAERVELDT SHUNT. AT THE BEGINNING OF THE CASE THE ANTERIOR CHAMBER WAS NOTED TO BE FLAT. A SIDE PORT INCISION WAS MADE, AND THE ANTERIOR CHAMBER WAS DEEPENED WITH COHESIVE VISCOELASTIC. THERE WAS A NOTICEABLE BLEB PRESENT OVER THE BEARVELDT TUBE SHUNT. THE CONJUNCTIVA WAS PEELED BACK REVEALING A FLOW THROUGH THE TUBE SHUNT. THE TUBE WAS REMOVED FROM THE ANTERIOR CHAMBER AND WAS TESTED WITH BSS (BALANCED SALINE SOLUTION). THERE WAS FLOW NOTED AROUND THE TUBE AND THROUGH THE FENESTRATION¿S STITCHES AND AT THE RESERVATION PLATE. THE DECISION WAS MADE TO EXCHANGE THE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Decreased

  MAUDE report 18188441 ↗
• InjuryApr 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S PARENT THAT THEIR DAUGHTER HAD TWO BAERVELDT GLAUCOMA SHUNTS IMPLANTED TIN BOTH EYES IN 2019. IN 2020, THE PATIENT HAD ORBITAL PANOPHTHALMITIS IN THE RIGHT EYE WITH NO COMPLICATIONS; HOWEVER, SOMETIME IN 2022, THE PATIENT HAD PANOPHTHALMITIS IN THE LEFT EYE. THE BAERVELDT GLAUCOMA SHUNT WAS EXTRACTED FROM THE LEFT EYE AND THAT LEFT EYE LOST VISION. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE GLAUCOMA IMPLANT WAS EXTRACTED FROM THE LEFT EYE DUE TO A STREPTOCOCCUS AUREUS INFECTION WHICH STARTED WITH AN ORBITAL CELLULITIS THAT DEVELOPED INTO ENDOPHTHALMITIS. BAERVELDT GLAUCOMA SHUNT SERVED AS AN ENTRY MODE FOR THE INFECTION. THE FINAL DIAGNOSIS WAS ENDOPHTHALMITIS SEPTAL CELLULITIS WITH PANOPHTHALMITIS. THE VISION WAS COMPLETELY LOST AND THERE IS NO SUBSEQUENT PERCEPTION OF LIGHT. PATIENT IS UNDER CONSTANT OBSERVATION, BECAUSE SHE ALSO HAS AN IMPLANT IN THE RIGHT EYE. THE PATIENT'S PARENT WAS NOT PROVIDED ANY OTHER INFORMATION, THEREFORE, HAD LIMITED INFORMATION TO PROVIDE JOHNSON & JOHNSON SURGICAL VISION. PATIENT HAD BILATERAL GLAUCOMA IMPLANTS. THIS REPORT CAPTURES THE GLAUCOMA IMPLANT IN PATIENTS LEFT EYE. ONLY THE LEFT EYE HAD THE REPORTABLE ISSUE.

  Patient problems: Endophthalmitis; Loss of Vision

  MAUDE report 14190901 ↗
• InjuryJun 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11971033 ↗
• InjuryJun 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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: Corneal Decompensation

  MAUDE report 11971008 ↗
• InjuryJun 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11970966 ↗