# Micromed Srl · 89-08 · ITALY — FDA import alert red lists: firms subject to detention without physical examination

For Micromed Srl · 89-08 · ITALY, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is ITALY; product is Perfluorodecaline | GasMate | Intraocular Silicone Oil | Perfluorodecaline | Intraocular Silicone Oil | GasMate; product code is 86 L - - PO Gases Used Within Eye To Place Pressure On Detached Retina | 86 L - - PO Gases Used Within Eye To Place Pressure On Detached Retina | 86 L - - PO Gases Used Within Eye To Place Pressure On Detached Retina | 86 L - - WL Fluid, Intraocular | 86 L - - WL Fluid, Intraocular | 86 L - - WL Fluid, Intraocular; date published is 09/29/2009; address is Via Oberdan 21 , Fonte Nuova, Rome ITALY, verified against its source on 2026-09-16.

- **Firm:** Micromed Srl _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** ITALY _(verified: appears in the quote below)_
- **Address:** Via Oberdan 21 , Fonte Nuova, Rome ITALY _(verified: appears in the quote below)_
- **Date published:** 09/29/2009 _(verified: appears in the quote below)_
- **Product code:** 86 L - - PO Gases Used Within Eye To Place Pressure On Detached Retina | 86 L - - PO Gases Used Within Eye To Place Pressure On Detached Retina | 86 L - - PO Gases Used Within Eye To Place Pressure On Detached Retina | 86 L - - WL Fluid, Intraocular | 86 L - - WL Fluid, Intraocular | 86 L - - WL Fluid, Intraocular _(verified: each item appears in the quote below)_
- **Product:** Perfluorodecaline | GasMate | Intraocular Silicone Oil | Perfluorodecaline | Intraocular Silicone Oil | GasMate _(verified: each item appears in the quote below)_
- **FDA notes:** Class III; 8/18/2009 | Class III; 8/18/2009 | Class III; 8/18/2009 | Class III; 8/18/2009 | Class III; 8/18/2009 | Class III; 8/18/2009 _(verified: each item appears in the quote below)_

## What the source says

> Micromed Srl Date Published : 09/29/2009 Via Oberdan 21 , Fonte Nuova, Rome ITALY 86 L - - PO Gases Used Within Eye To Place Pressure On Detached Retina Date Published: 01/23/2019 Desc: Perfluorodecaline Notes: Class III; 8/18/2009 86 L - - PO Gases Used Within Eye To Place Pressure On Detached Retina Date Published: 01/23/2019 Desc: GasMate Notes: Class III; 8/18/2009 86 L - - PO Gases Used Within Eye To Place Pressure On Detached Retina Date Published: 01/23/2019 Desc: Intraocular Silicone Oil Notes: Class III; 8/18/2009 86 L - - WL Fluid, Intraocular Date Published: 01/23/2019 Desc: Perfluorodecaline Notes: Class III; 8/18/2009 86 L - - WL Fluid, Intraocular Date Published: 01/23/2019 Desc: Intraocular Silicone Oil Notes: Class III; 8/18/2009 86 L - - WL Fluid, Intraocular Date Published: 01/23/2019 Desc: GasMate Notes: Class III; 8/18/2009

## The same source also states

> Micromed Srl Date Published : 01/23/2019 Vle Valpadana 126 , Romaroma, ITALY 86 L - - PO Gases Used Within Eye To Place Pressure On Detached Retina Date Published: 01/23/2019 Desc: Intraocular Silicone Oil Notes: Class III; 8/18/2009 86 L - - PO Gases Used Within Eye To Place Pressure On Detached Retina Date Published: 01/23/2019 Desc: GasMate Notes: Class III; 8/18/2009 86 L - - PO Gases Used Within Eye To Place Pressure On Detached Retina Date Published: 01/23/2019 Desc: Perfluorodecaline Notes: Class III; 8/18/2009 86 L - - WL Fluid, Intraocular Date Published: 01/23/2019 Desc: GasMate Notes: Class III; 8/18/2009 86 L - - WL Fluid, Intraocular Date Published: 01/23/2019 Desc: Perfluorodecaline Notes: Class III; 8/18/2009 86 L - - WL Fluid, Intraocular Date Published: 01/23/2019 Desc: Intraocular Silicone Oil Notes: Class III; 8/18/2009

Source: https://www.accessdata.fda.gov/cms_ia/importalert_244.html

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).