MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2019-03-19 for BIOTRUE ONEDAY(NESOFILCON A)CONTACT LENS manufactured by Bausch & Lomb Incorporated.
[139167650]
The complaint lens, doctors contact information and additional medical information have been requested but not received. 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
[139167651]
A consumer reported that while skiing, they attempted to remove a lens from their right eye multiple times but were unable to. After experiencing pain, the consumer visited an eye clinic on an unknown day. No lens material was found in the eye; however, slight bleeding was observed. The clinic performed an eye wash and recommend that the consumer follow up with their eye doctor. The consumer was seen the next day by the eye doctor and was diagnosed with a corneal injury. The consumer reported that a corneal suture surgery was performed the day after the diagnosis. The consumer did not require hospitalization and at their follow up appointment the doctor observed they were 90% recovered. The consumer was cleared to play sports at the time of this visit, however there was some bleeding in the center of the right eye. The consumer was prescribed levofloxacin opthalmic solution, hyalonsan ophthalmic solution, flumetholon ophthalmic suspension and ofloxin ophthalmic. They were instructed to return for a follow up appointment. Doctors contact information and additional medical information was requested but has not been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2019-00052 |
| MDR Report Key | 8431600 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2019-03-19 |
| Date of Report | 2019-02-21 |
| Device Manufacturer Date | 2017-04-12 |
| Date Added to Maude | 2019-03-19 |
| 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. 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 | 2019-03-19 |
| Lot Number | W77214440 |
| 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 | 2019-03-19 |