Instrumed International, Inc. 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. Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Instrumed International, Inc.
Lot Codes / Batch Numbers
1) Instrumed Product Name: Schoitz Tonometer, Instrumed Product Number: 720-55800, Trade Name: Millennium Surgical, Millennium Surgical Product Name: Schoitz Tonometer, Millennium Surgical Item Number: 3-5754, Lot Number: 030212. 2) Instrumed Product Name: Schoitz Tonometer, Instrumed Product Number: 720-55800, Trade Name: Symmetry Surgical, Symmetry Surgical Product Name: Schoitz Tonometer, Symmetry Surgical Item Number: 60-6031, Lot Numbers: 030212, 030413, 040113, 100312, 120113. 3) Instrumed Product Name: Schoitz Tonometer, Instrumed Product Number: 720-55800, Trade Name: Accutome, Accutome Product Name: Schoitz Tonometer, Accutome Item Number: AM0530, Lot Number: 030212, 120113. 4) Instrumed Product Name: Schoitz Tonometer, Instrumed Product Number: 720-55800, Trade Name: Boss Instruments, Boss Instruments Product Name: Schoitz Tonometer, Boss Instruments Item Number: 80-9010, Lot Number: 100312. 5) Instrumed Product Name: Schoitz Tonometer, Instrumed Product Number: 720-55800, Trade Name: Medline Industries, Medline Industries Product Name: Tonometer, Eye, Schiotz, w/ 3 Weights, Case, Medline Industries Item Number: MDG0781649, Lot Number: 030212, 040113, 100312, 120113.
Products Sold
1) Instrumed Product Name: Schoitz Tonometer; Instrumed Product Number: 720-55800; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Schoitz Tonometer; Millennium Surgical Item Number: 3-5754; Lot Number: 030212. 2) Instrumed Product Name: Schoitz Tonometer; Instrumed Product Number: 720-55800; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Schoitz Tonometer; Symmetry Surgical Item Number: 60-6031; Lot Numbers: 030212, 030413, 040113, 100312, 120113. 3) Instrumed Product Name: Schoitz Tonometer; Instrumed Product Number: 720-55800; Trade Name: Accutome; Accutome Product Name: Schoitz Tonometer; Accutome Item Number: AM0530; Lot Number: 030212, 120113. 4) Instrumed Product Name: Schoitz Tonometer; Instrumed Product Number: 720-55800; Trade Name: Boss Instruments; Boss Instruments Product Name: Schoitz Tonometer; Boss Instruments Item Number: 80-9010; Lot Number: 100312. 5) Instrumed Product Name: Schoitz Tonometer; Instrumed Product Number: 720-55800; Trade Name: Medline Industries; Medline Industries Product Name: Tonometer, Eye, Schiotz, w/ 3 Weights, Case; Medline Industries Item Number: MDG0781649; Lot Number: 030212, 040113, 100312, 120113.
Instrumed International, Inc. is recalling Tonometers are manual devices intended to measure intraocular pressure by applying a known force on due to 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, . This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026