MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2020-01-02 for DAILIES TOTAL 1 CBV92004051 manufactured by Alcon Research, Llc.
[188836084]
The complaint sample has not returned for evaluation. 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
[188836085]
It was reported on (b)(6) 2019, that a consumer had to throw out a couple of lenses due to it not being clear. Additional information was received on 12dec2019 clarifying that the lenses were only blurry once placed on the eye. It was also reported that the lenses did not sit correctly on the eye after an hour or so and would therefore cause irritation. It was reported that the consumer suffered from a corneal ulcer resulting to the need to seek medical help and the consumer had to go to a number of appointments and an emergency specialist. Treatment modality, duration and eye involvement was not disclosed. The corneal ulcer has resolved leaving only minor scarring and the consumer is able to wear lenses again.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1065835-2020-00001 |
| MDR Report Key | 9537579 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2020-01-02 |
| Date of Report | 2020-01-24 |
| Date of Event | 2019-06-28 |
| Date Mfgr Received | 2020-01-03 |
| Device Manufacturer Date | 2019-01-23 |
| Date Added to Maude | 2020-01-02 |
| 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. 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 | 2020-01-02 |
| Model Number | NA |
| Catalog Number | CBV92004051 |
| Lot Number | A5057878 |
| 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 | 2020-01-02 |