MWL

Product Code: MWL

Products Classified as MWL

4360

Lens, Contact (rigid Gas Permeable), Extended Wear

Rigid Gas Permeable Contact Lens.

Total Product Life Cycle (TPLC) Devices

4360

Lens, Contact (rigid Gas Permeable), Extended Wear

Rigid Gas Permeable Contact Lens.

FDA Consensus Standards

• Lens, Contact (Rigid Gas Permeable), Extended Wear [37850]: 21 CFR §886.5916 🔎
• Lens, Contact (Rigid Gas Permeable), Extended Wear [37852]: 21 CFR §886.5916 🔎
• Lens, Contact (Rigid Gas Permeable), Extended Wear [37869]: 21 CFR §886.5916 🔎
• Lens, Contact (Rigid Gas Permeable), Extended Wear [31258]: 21 CFR §886.5916 🔎
• Lens, Contact (Rigid Gas Permeable), Extended Wear [38769]: 21 CFR §886.5916 🔎
• Lens, Contact (Rigid Gas Permeable), Extended Wear [37075]: 21 CFR §886.5916 🔎
• Lens, Contact (Rigid Gas Permeable), Extended Wear [38809]: 21 CFR §886.5916 🔎
• Lens, Contact (Rigid Gas Permeable), Extended Wear [33619]: 21 CFR §886.5916 🔎
• Lens, Contact (Rigid Gas Permeable), Extended Wear [34448]: 21 CFR §886.5916 🔎
• Lens, Contact (Rigid Gas Permeable), Extended Wear [37081]: 21 CFR §886.5916 🔎
• Lens, Contact (Rigid Gas Permeable), Extended Wear [37077]: 21 CFR §886.5916 🔎
• Lens, Contact (Rigid Gas Permeable), Extended Wear [37868]: 21 CFR §886.5916 🔎

Pre-market Approvals for MWL

P850038	PARAPERM E.W. BLUE RIGID GAS PERMEABLE CONTACT LEN	PARAGON OPTICAL CO.
P860022	BOSTON EQUALENS (ITAFLUROFOCON A)/EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS	POLYMER TECHNOLOGY CORP.
P880098	MENICON SF-P RGP (MELAFOCON A) CONTACT LENS	MENICON CO. LTD.
P890020	FLUOROCON TM-60	CIBA VISION CORPORATION
P990018	MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS	MENICON CO. LTD.
P050031	PARAGON CRT LENS	PARAGON VISION SCIENCES
P010062	BOSTON ORTHOKERATOLOGY SHAPING LENS FOR OVERNIGHT WEAR	BAUSCH & LOMB
P870024	FluoroPerm 92, FluoroPerm 60, FluoroPerm 30, FluoroPerm 151, HDS and HDS 100	PARAGON VISION SCIENCES

Global Unique Device Identification Database

• 00785811435639: Lens,Contact(Rigid Gas Permeable)-Extended Wear
• 00785811435622: Lens,Contact(Rigid Gas Permeable)-Extended Wear
• 00884465092011: Lens,Contact(Rigid Gas Permeable)-Extended Wear
• 00884465091014: Lens,Contact(Rigid Gas Permeable)-Extended Wear
• B22204: Lens,Contact(Rigid Gas Permeable)-Extended Wear
• B22203: Lens,Contact(Rigid Gas Permeable)-Extended Wear
• 00192538901086: Lens, Contact (Rigid Gas Permeable), Extended Wear

Maude Adverse Events

RIGID GAS PERMEABLE CONTACTS	ART OPTICAL CONTACT LENS	2020-01-24
ORTHOKERATOTIC CONTACT LENS	EUCLID SYSTEMS CORP.	2019-07-31
ORTHOKERATOTIC CONTACT LENS	EUCLID SYSTEMS CORP	2019-07-31
PARAGON CRT CONTACT LENS	PARAGON VISION SCIENCES, INC.	2019-05-10
PARAGON CRT100 CONTACT LENS	PARAGON VISION SCIENCES, INC.	2019-04-29
ORTHOKERATOLOGY CONTACT LENSES		2018-12-11
PARAGON Z CRT	PARGAON VISION SCIENCES	2018-10-09
CRTCRT CONTACT LENS	PARAGON	2017-04-12
MENICON Z RIGID GAS PERMEABLE LENS	MENICON CO. LTD.	2012-12-26
MENICON EX-Z RIGID GAS PERMEABLE LENS	MENICON CO. LTD.	2012-02-07
MENICON Z RIGID GAS PERMEABLE LENS	MENICON CO. LTD.	2010-06-13
MENICON Z RIGID GAS PERMEABLE LENS MATERIAL	MENICON CO. LTD.	2010-04-29
**	*	2004-06-22
MENICON Z RIGID GAS PERMEABLE (RGP) CONTACT LENS	MENICON CO. LTD.	2004-06-22
MENICON Z RIGID GAS PERMEABLE (RGP) CONTACT LENS	MENICON CO. LTD.	2004-04-23
**	*	2004-04-23
MENICON Z RIGID GAS PERMEABLE (RGP) CONTACT LENS	MENICON CO. LTD.	2004-04-23
**	*	2004-04-23
MENICON Z RIGID GAS PERMEABLE (RGP) CONTACT LENS	MENICON CO., LTD.	2003-12-16
		2003-12-16
BOSTON EQUALENS II	BAUSCH & LOMB, INC.	2001-07-26