MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-08 for DAILIES TOTAL 1 CBV92004051 manufactured by Alcon Research, Llc.
[175227584]
(b)(4). The complaint sample has not returned for evaluation; the lot number is unknown. Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[175227585]
It was reported on 19dec2019 via email that a consumer experienced a blurry, painful, red and photophobic right eye on (b)(6) 2019. It was also reported that the eye affected was only the right eye. The consumer sought medical attention on (b)(6) 2019 and was diagnosed with corneal infiltrate/ulcer. The consumer was prescribed with tobramycin and dexamethasone ophthalmic suspension every 30 minutes for four hours then every four hours thereafter, the duration of the treatment was not indicated. It was reported that the symptoms have resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1065835-2020-00002 |
| MDR Report Key | 9563505 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-08 |
| Date of Report | 2020-01-29 |
| Date of Event | 2019-10-21 |
| Date Mfgr Received | 2020-01-08 |
| Device Manufacturer Date | 2019-04-22 |
| Date Added to Maude | 2020-01-08 |
| 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. JASON MICHAELIDES |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175686438 |
| Manufacturer G1 | ALCON RESEARCH, LLC |
| Manufacturer Street | 11440 JOHNS CREEK PARKWAY |
| Manufacturer City | DULUTH GA 30097 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30097 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DAILIES TOTAL 1 |
| Generic Name | LENSES, SOFT CONTACT, DAILY WEAR |
| Product Code | LPL |
| Date Received | 2020-01-08 |
| Model Number | NA |
| Catalog Number | CBV92004051 |
| Lot Number | A5062751 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LLC |
| Manufacturer Address | 11440 JOHNS CREEK PARKWAY DULUTH GA 30097 US 30097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-08 |