MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-11-18 for AIR OPTIX NIGHT & DAY AQUA CBV92002040 manufactured by Pt. Ciba Vision Batam.
| Report Number | 9681121-2019-00016 |
| MDR Report Key | 9334054 |
| Report Source | CONSUMER |
| Date Received | 2019-11-18 |
| Date of Report | 2019-11-18 |
| Date of Event | 2019-10-11 |
| Date Mfgr Received | 2019-10-25 |
| Device Manufacturer Date | 2019-04-30 |
| Date Added to Maude | 2019-11-18 |
| 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 | MS. CINDY MILAM |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152231 |
| Manufacturer G1 | PT. CIBA VISION BATAM |
| Manufacturer Street | BERINGIN KAV. #204 BATAMINDO INDUSTRIAL PARK MUKA KUNING |
| Manufacturer City | PULAU BATAM 29433 |
| Manufacturer Country | ID |
| Manufacturer Postal Code | 29433 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIR OPTIX NIGHT & DAY AQUA |
| Generic Name | LENSES, SOFT CONTACT, DAILY WEAR |
| Product Code | LPL |
| Date Received | 2019-11-18 |
| Model Number | NA |
| Catalog Number | CBV92002040 |
| Lot Number | 31398756 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PT. CIBA VISION BATAM |
| Manufacturer Address | BERINGIN KAV. #204 BATAMINDO INDUSTRIAL PARK MUKA KUNING PULAU BATAM 29433 ID 29433 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-11-18 |