Molteno3 SL-245Recalls & reported problems
Molteno Ophthalmic Limited · Molteno3 SL (245mm2) Glaucoma Drainage Device · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 09419196000229), received between Jun 11, 2026 and Jun 11, 2026 — classified as 2 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 11, 2026Appropriate Device Problem Term/Code Not Available
A MOLTENO3 SL-245 WAS IMPLANTED THEN EXPLANTED. CUSTOMER RELAYED THAT THE TUBE WAS NOT LIGATING. THE SURGEON EXPLANTED THE DEVICE AND REPLACED IT WITH A DIFFERENT BRAND GLAUCOMA DRAINAGE DEVICE WITH NO ISSUE.
Patient problems: Insufficient Information
MAUDE report 25480674 ↗InjuryJun 11, 2026Appropriate Device Problem Term/Code Not Available
A MOLTENO3 SL-245 WAS IMPLANTED THEN EXPLANTED. CUSTOMER RELAYED THAT THE TUBE WAS NOT LIGATING. THE SURGEON EXPLANTED THE DEVICE AND REPLACED IT WITH A DIFFERENT BRAND GLAUCOMA DRAINAGE DEVICE WITH NO ISSUE.
Patient problems: Insufficient Information
MAUDE report 25480630 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.