MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-12-30 for DAILIES TOTAL 1 CBV92004051 manufactured by Alcon Research, Llc.
[175222967]
The lot number was not provided and the complaint sample was not made available for evaluation. The investigation consisted of a review of the complaint trend for category corneal ulcer infectious for delefilcon (dailies total 1) product. A product specific investigation was not performed as no lot number was available. No sample evaluation was completed as no product was returned. There were no adverse trends identified for complaint category corneal ulcer infectious for this product from (b)(6) 2017 to (b)(6) 2019. A root cause was not confirmed. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[175222968]
It was reported by an eye care professional on 05dec2019, that three consumers had come into office with corneal ulcers over the course of the past month. It was reported that none of the consumers were misusing the lenses in any way. Additional information has been requested but not yet received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1065835-2019-00021 |
| MDR Report Key | 9529234 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-12-30 |
| Date of Report | 2020-03-09 |
| Date of Event | 2019-10-16 |
| Date Mfgr Received | 2020-02-13 |
| Device Manufacturer Date | 2017-03-08 |
| Date Added to Maude | 2019-12-30 |
| 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 | 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 | 2019-12-30 |
| Returned To Mfg | 2020-01-24 |
| Model Number | NA |
| Catalog Number | CBV92004051 |
| Lot Number | A5022716 |
| Device Expiration Date | 2020-02-29 |
| 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 | ALCON RESEARCH, LLC |
| Manufacturer Address | 11440 JOHNS CREEK PARKWAY DULUTH GA 30097 US 30097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-12-30 |