MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-12-19 for BIOTRUE ONEDAY(NESOFILCON A)CONTACT LENS manufactured by Bausch & Lomb Incorporated.
[130902978]
The device is not available for evaluation as it was discarded. A review of the lot manufacturing records is in progress. 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
[130902979]
A practitioner reported one of their patients informed them there was a piece of plastic on one of the lenses. The patient visited a hospital on an unknown date where the lens and/or the piece of plastic was removed with tweezers from the eye. It is unknown if the patient received any additional treatment in the hospital or after the visit. Additional medical information was requested but has not been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2018-00241 |
| MDR Report Key | 8181002 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-12-19 |
| Date of Report | 2018-11-20 |
| Device Manufacturer Date | 2018-05-27 |
| Date Added to Maude | 2018-12-19 |
| 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 | 2018-12-19 |
| Lot Number | W87302605 |
| 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 | BAUSCH & LOMB INCORPORATED |
| Manufacturer Address | 1400 NORTH GOODMAN STREET ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-19 |