Reported Dec 17, 2014 · Terminated
Tonometers are manual devices intended to measure intraocular pressure by applying a known force on the globe of the…
Instrumed International, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Instrumed International, Inc. · 626 Cooper Ct · Schaumburg, IL · 60173-4537
Is this the product you have?
- Tonometers are manual devices intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea) and are sold under the Millennium Surgical, Symmetry Surgical, Accutome, Boss Instruments, and Medline Industries brand names.
- Lot codes and dates
26 of 26 products
Products covered by this recall Model / number Product as published — Schoitz Tonometer 720-55800Instrumed — Trade Name: Millennium Surgical — Millennium Surgical Product Name: Schoitz Tonometer 3-5754Millennium Surgical — Lot Number: 030212. 2) Instrumed Product Name: Schoitz Tonometer 720-55800Instrumed — Trade Name: Symmetry Surgical — Symmetry Surgical Product Name: Schoitz Tonometer 60-6031Symmetry Surgical — Lot Numbers: 030212, 030413, 040113, 100312, 120113. 3) Instrumed Product Name: Schoitz Tonometer 720-55800Instrumed — Trade Name: Accutome — Accutome Product Name: Schoitz Tonometer AM0530Accutome — Lot Number: 030212, 120113. 4) Instrumed Product Name: Schoitz Tonometer 720-55800Instrumed — Trade Name: Boss Instruments — Boss Instruments Product Name: Schoitz Tonometer 80-9010Boss Instruments - Amount recalled
- 23 tonometers
This recall covers 28 products
The agency filed one notice per product. You are reading one of them; the other 27 are below.
15 more are in the archive.
Where it was sold
Why it was recalled
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
This product could cause temporary or reversible health problems — stop using it.
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