Alcon
Sapphire Wide Angle Illuminator, Wide Angle Tip, 20Ga, 2.5m
1manufacturer
14catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| ABA Medical Technology Co Ltd | Guang Dong | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Alcon Laboratories, Inc., United States |
|---|---|
| FDA product code | HQE |
| Device type | Instrument, Vitreous Aspiration And Cutting, Ac-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.4150 |
| Record published | 2016-09-24 |
| Record revised | 2024-03-22 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 12, box of 10, box of 6 |
| Sizes | Length 2 to 2.5 m; length 6 mm; outer diameter 0.5 mm |
| Distribution end date | 2024-09-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8065751448 | 25 Gauge | In distribution |
| 8065751800 | 23 Gauge | In distribution |
| 8065751585 | 23 Gauge | In distribution |
| 8065751446 | 23 Gauge | In distribution |
| 8065751449 | 25 Gauge | In distribution |
| 00380650003935 | In distribution | |
| 8065740258 | Length 2.1 m | Withdrawn |
| 8065750425 | 20 Gauge | Withdrawn |
| 8065751889 | 23 Gauge | Withdrawn |
| 8065751778 | Length 6 mm | Withdrawn |
| 8065751589 | 25 Gauge | Withdrawn |
| 8065740260 | Length 2.1 m | Withdrawn |
| 8065740257 | Outer Diameter 0.5 mm | Withdrawn |
| 8065750426 | 25 Gauge | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bausch + Lomb | Bausch & Lomb Incorporated | 108 |
| Unity | Alcon Laboratories, Inc. | 47 |
| Synergetics | Synergetics USA, Inc. | 44 |
| Bi-Blade® | Medical Instrument Development Laboratories, Inc. | 28 |
| Instrument, Vitreous Aspiration And Cutting, Ac-Powered | Medical Instrument Development Laboratories, Inc. | 21 |
| Constellation | Alcon Laboratories, Inc. | 9 |
| Stellaris | Bausch & Lomb Incorporated | 6 |
| EVA Nexus™ Posterior 25G TDC Pack | D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. | 4 |
| EVA Nexus™ Posterior 23G TDC Pack | D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. | 4 |
| EVA Nexus™ Posterior 27G TDC Pack | D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. | 4 |
| Engauge, Vektor | Alcon Laboratories, Inc. | 3 |
| Alcon, Engauge | Alcon Laboratories, Inc. | 3 |
Showing 12 of 65. All products under Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Alcon Research, LLC | UDI-DI | 2025-08-05 | Class II | Process control | Due to incomplete seals in the pouch which provide the sterile barrier. | 6 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.