MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-11 for AIR OPTIX PLUS HYDRAGLYDE CBV92071303 manufactured by Ciba Vision Johor Sdn, Bhd..
| Report Number | 3006186389-2020-00001 |
| MDR Report Key | 9691586 |
| Report Source | CONSUMER |
| Date Received | 2020-02-11 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-11-01 |
| Date Mfgr Received | 2020-03-27 |
| Device Manufacturer Date | 2018-03-15 |
| Date Added to Maude | 2020-02-11 |
| 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 |
| 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 JOHOR SDN, BHD. |
| Manufacturer Street | #1 DPB/5 TANJUNG PELEPAS PORT GELANG PATAH |
| Manufacturer City | JOHOR DARUL TAKZIM JOHOR 81560 |
| Manufacturer Country | MY |
| Manufacturer Postal Code | 81560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIR OPTIX PLUS HYDRAGLYDE |
| Generic Name | EXTENDED WEAR SOFT CONTACT LENS |
| Product Code | LPM |
| Date Received | 2020-02-11 |
| Returned To Mfg | 2020-03-12 |
| Model Number | NA |
| Catalog Number | CBV92071303 |
| Lot Number | 10401418 |
| 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 JOHOR SDN, BHD. |
| Manufacturer Address | #1 DPB/5 TANJUNG PELEPAS PORT GELANG PATAH JOHOR DARUL TAKZIM JOHOR 81560 MY 81560 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-11 |