Disposable EVA Drapes
Catalogue number 8110.DRA01, listed by D.o.r.c. Dutch Ophthalmic Research Center (International) B.V., Netherlands, under Unit, Phacofragmentation. 4 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Guangdong (2), Shanghai (1), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Providence Enterprise Limited | Shenzhen | Guangdong | Contract manufacturer | 9 |
| ABA Medical Technology Co Ltd | Guang Dong | Guangdong | Contract manufacturer | 6 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
Record
| Listed by | D.o.r.c. Dutch Ophthalmic Research Center (International) B.V., Netherlands |
|---|---|
| FDA product code | HQC |
| Device type | Unit, Phacofragmentation |
| Device class | Class 2 |
| Regulation | 21 CFR 886.4670 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K190875 |
| Record published | 2016-09-23 |
| Record revised | 2020-03-19 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 8110.DRA01 | 6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bausch + Lomb | Bausch & Lomb Incorporated | 109 |
| Alcon | Alcon Laboratories, Inc. | 95 |
| Oertli® | Oertli Instrumente AG | 66 |
| Laminar | Johnson & Johnson Surgical Vision, Inc. | 40 |
| Engauge | Alcon Laboratories, Inc. | 18 |
| Unity | Alcon Laboratories, Inc. | 18 |
| Constellation | Alcon Laboratories, Inc. | 16 |
| MST/Packard A1.7mm Phaco Tip Bent Dewey 30° | Microsurgical Technology, Inc. | 11 |
| Whitestar Signature | Johnson & Johnson Surgical Vision, Inc. | 10 |
| Alcon, Infiniti, MicroSmooth, ABS | Alcon Laboratories, Inc. | 10 |
| Compact Intuitiv | Johnson & Johnson Surgical Vision, Inc. | 9 |
| Alcon, Infiniti, Intrepid | Alcon Laboratories, Inc. | 9 |
Showing 12 of 619. All products under Unit, Phacofragmentation
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Dutch Ophthalmic USA, Inc. | 510(k) number | 2019-05-21 | Class II | Under Investigation by firm | Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line | 16 boxes |
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-01-15 | Class II | Process control | When using those products you may experience difficulties to extend or retract the laser fiber, and in some occasions may also have difficulties to direct the laser fiber tip precisely. | 14 boxes x 6 units per box = 84 units |
| 2024-01-15 | Class II | Process control | When using those products you may experience difficulties to extend or retract the laser fiber, and in some occasions may also have difficulties to direct the laser fiber tip precisely. | 13 boxes x 6 units per box = 78 units |
| 2024-01-15 | Class II | Process control | When using those products you may experience difficulties to extend or retract the laser fiber, and in some occasions may also have difficulties to direct the laser fiber tip precisely. | 21 boxes x 6 units each = 126 units |
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.