MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-11-01 for BIOTRUE ONEDAY(NESOFILCON A)CONTACT LENS manufactured by Bausch & Lomb Incorporated.
[125828585]
Additional information was requested from the doctor with no response. A lot number was not provided. Based on all available information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[125828586]
A practitioner reported to a sales representative that a patient had an ulcer as a result of wearing the lenses. The practitioner indicated that no patient information would be given. Numerous attempts were made to contact the practitioner for details regarding the event without success. For the initial report to the sales representative, the practitioner did not report symptoms, location or size of the ulcer, vision loss or treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2018-00198 |
| MDR Report Key | 8029032 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-01 |
| Date of Report | 2018-10-04 |
| Date Added to Maude | 2018-11-01 |
| 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 | MS. JENNIFER GAMET |
| Manufacturer Street | 1400 NORTH GOODMAN STREET |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 5853386853 |
| Manufacturer G1 | BAUSCH + LOMB |
| Manufacturer Street | UNIT 424/425, CORK ROAD INDUSTRIAL ESTATE |
| Manufacturer City | WATERFORD |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOTRUE ONEDAY(NESOFILCON A)CONTACT LENS |
| Generic Name | LENS, CONTACT, DISPOSABLE |
| Product Code | MVN |
| Date Received | 2018-11-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH & LOMB INCORPORATED |
| Manufacturer Address | 1400 NORTH GOODMAN STREET ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-01 |