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INSIGHT INSTRUMENTS, INC.

Last updated May 24, 2026

Information

Device	Model / Reference	Registries	Class	Status
Insight Instruments, Inc. Vitreous Biopsy Probe 27 Ga	71007	FDA UDI	Class II	Active
SUPER VIEW® Disposable Wide Field Lens Set for RESIGHT®	40414	FDA UDI	Class I	Active
Intrector®	71101	FDA UDI	Class II	Active
Intrector®	71004	FDA UDI	N/A	Active
Intrector®	71004.100	FDA UDI	Class II	Active
SUPER VIEW® Pack for ZEISS RESIGHT®	TS-RP-7002	FDA UDI	N/A	Active
SUPER VIEW® Disposable Lens Set for ZEISS RESIGHT®	TS-ZR-LS	FDA UDI	Class II	Active
Retrector®	71005	FDA UDI	N/A	Active
SUPER VIEW® Disposable Lens Set for RESIGHT®	40219	FDA UDI	Class II	Active
Insight Instruments, Inc. Vitreous Biopsy Probe 27 Ga	71007.100	FDA UDI	Class II	Active
SUPER VIEW® Disposable Wide Field Lens for ZEISS RESIGHT®	TS-ZR-SV	FDA UDI	Class I	Active
Retrector®	71005.100	FDA UDI	Class II	Active
Intrector®	71200	FDA UDI	N/A	Active
SUPER VIEW® Pack for ZEISS RESIGHT®	TS-RP-7001	FDA UDI	N/A	Active
Insight Instruments, Inc. Infusion Cannula	60013	FDA UDI	Class I	Active
Intrector®	71102	FDA UDI	Class II	Active
Insight 4000 Endoscope	K000252	FDA 510(k)	Class II	Active
Super View Disposable Biom Lens Set	K051630	FDA 510(k)	Class II	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jun 27, 2013	Z-0144-2014	—	terminated	The product was registered and distributed as a Class I medical device and was subsequently determined to be a Class II medical device which requires FDA market clearance.
Mar 15, 2013	Z-1281-2013	—	terminated	Insight Instruments, Inc., Stuart, FL is recalling M.I.S. (Multi-Port Illumination System), Ophthalmic Cannula due to a misclassification of the medical device.
May 12, 2010	Z-2221-2010	—	terminated	Insight Instruments, Inc., Stuart, FL is recalling CORNEA COAT 2.5% Hydroxypropylmethylcellulose solution in 1.5 ml Syringe due to a potential weakness of the peel pouch seals. Products affected are Item Numbers 600100.000 sold individually and 40201.000 thru 10206.000 sold as components of BIOM Pack.
May 12, 2010	Z-2220-2010	—	terminated	Insight Instruments, Inc., Stuart, FL is recalling CORNEA COAT 2.5% Hydroxypropylmethylcellulose solution in 1.5 ml Syringe due to a potential weakness of the peel pouch seals. Products affected are Item Numbers 600100.000 sold individually and 40201.000 thru 10206.000 sold as components of BIOM Pack.