BAERVELDT PARS PLANA GLAUCOMA IMPLANT BG102350Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · GLAUCOMA IMPLANT BG102-350 GLOBAL · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474513006), received between Apr 12, 2019 and Jul 28, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Complete Blockage” (2 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.
Reports received per month
Most reported problems
Device problems
- Complete Blockage2
- Device Dislodged or Dislocated1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Endophthalmitis1
- No Code Available1
- Vitrectomy1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50063563 ↗MalfunctionJul 14, 2022Complete Blockage; Complete Blockage
IT WAS REPORTED THAT THE WATER FLOW IN A GLAUCOMA IMPLANT SHUNT WAS CHECKED DURING THE PRE-OPERATIVE PREPARATION STAGE AND THE WATER DID NOT FLOW OR IT WAS DIFFICULT TO GET THROUGH. THE CUSTOMER THEN REPLACED IT WITH A NEW PRODUCT. THE PATIENT IS OK. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15021906 ↗InjuryApr 12, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT A GLAUCOMA SHUNT (BG102-350) IMPLANTED IN THE SUMMER OF 2017 WAS EXPOSED FROM THE SCLERA AND IT CAUSED ENDOPHTHALMITIS. THE GLAUCOMA SHUNT WAS PUT ON A 6 MM × 6 MM SCLERA SEMI-SECTION INCISION, BUT IT PIERCED AND EXPOSED THE SCLERA. THE PRODUCT WAS EXPLANTED AND VITRECTOMY WAS PERFORMED AT THE SAME TIME. ANTIMICROBIAL TREATMENT IS CURRENTLY BEING PERFORMED. THE PREOPERATIVE VISION WAS 0.06, BUT IT DROPPED TO 0.02 LAST FALL AND NOW THE SYMPTOMS ARE STABLE WITH A MANUAL VALVE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Endophthalmitis; No Code Available; Vitrectomy
MAUDE report 8507602 ↗
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- BAERVELDT GLAUCOMA IMPLANT (350) BG101350Johnson & Johnson Surgical Vision, Inc. · IMPLANT, EYE VALVE35 reports
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- EX-PRESS® P-50Alcon Laboratories, Inc. · Implant, Eye Valve12 reports
- Ahmed™ ClearPath 250New World Medical, Incorporated · IMPLANT, EYE VALVE6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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