FDA Device recall Z-0558-2015

Tonometers are manual devices intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the…

FDA Device
Class II
terminated
Published 2014-12-17

On 2014-12-17 the FDA classified a Class II recall of Tonometers are manual devices intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the… by Instrumed International, citing the reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0558-2015
Classification	Class II
Status	terminated
Initiated	2014-09-08
Published	2014-12-17
Last updated	2026-09-13 11:53 UTC
Company	Instrumed International
Distribution	US

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.

Reason

The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.

Identifiers

code_info	1) Instrumed Product Name: Schoitz Tonometer; Instrumed Product Number: 720-55800; Trade Name: Millennium Surgical; Mil… 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 Numbe

code_info

1) Instrumed Product Name: Schoitz Tonometer; Instrumed Product Number: 720-55800; Trade Name: Millennium Surgical; Mil…

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 Numbe

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0558-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.