MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-12-09 for BIOTRUE MULTI-PURPOSE SOLUTION manufactured by Bausch & Lomb Incorporated.
[61861071]
The complaint sample was not available for evaluation and the lot number is unknown. Additional medical information has been requested but has not been received. Based on available information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
[61861072]
Eye care professional reported that while being seen for a lens fitting, patient? S lenses were placed into the contact lens solution for a few minutes. Patient reinserted lenses. A few hours later, the patient returned to the office and reported painful and red eyes. Doctor placed one drop of anti-inflammatory drop, ilevro, into each eye. Office reports patient to be fully recovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001313525-2016-00768 |
| MDR Report Key | 6157553 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-12-09 |
| Date of Report | 2016-11-16 |
| Date of Event | 2016-11-11 |
| Date Mfgr Received | 2016-11-16 |
| Date Added to Maude | 2016-12-09 |
| 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. SHARON SPENCER |
| Manufacturer Street | 50 TECHNOLOGY DRIVE WEST |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9493985698 |
| Manufacturer G1 | BAUSCH + LOMB |
| Manufacturer Street | 8507 PELHAM ROAD |
| Manufacturer City | GREENVILLE SC 29615 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 29615 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOTRUE MULTI-PURPOSE SOLUTION |
| Generic Name | ACCESSORIES, SOLUTION, CLEANERS FOR LENSES |
| Product Code | LYL |
| Date Received | 2016-12-09 |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2016-12-09 |