MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-01-09 for DAILIES AQUACOMFORT PLUS CBV92001362 manufactured by Ciba Vision Asian Mfg And Logistics Pte Ltd..
| Report Number | 3003657720-2020-00001 |
| MDR Report Key | 9573231 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-01-09 |
| Date of Report | 2020-03-06 |
| Date of Event | 2019-10-19 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2018-11-07 |
| Date Added to Maude | 2020-01-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JONATHAN SCHLECH |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175514979 |
| Manufacturer G1 | CIBA VISION ASIAN MFG AND LOGISTICS PTE LTD. |
| Manufacturer Street | 133 TUAS SOUTH AVENUE 3 |
| Manufacturer City | TUAS 637550 |
| Manufacturer Country | SN |
| Manufacturer Postal Code | 637550 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DAILIES AQUACOMFORT PLUS |
| Generic Name | LENSES, SOFT CONTACT, DAILY WEAR |
| Product Code | LPL |
| Date Received | 2020-01-09 |
| Returned To Mfg | 2020-02-04 |
| Model Number | NA |
| Catalog Number | CBV92001362 |
| Lot Number | C0353529 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CIBA VISION ASIAN MFG AND LOGISTICS PTE LTD. |
| Manufacturer Address | 133 TUAS SOUTH AVENUE 3 TUAS 637550 SN 637550 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-09 |