MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-02-21 for BOSTON ADVANCE CONDITIONING SOLUTION manufactured by Bausch & Lomb, Inc..
[4236649]
Pt reported experiencing a corneal ulcer and also three eye infections. Reaction onset dates were not provided. The patient stated she recovered and was not sure if she would sign and return the medical release or provide her doctor's info. The pt reported using the solution incorrectly by rinsing with tap water in the morning after soaking her contact lenses in the conditioning solution. She stated the product was discarded and requested coupons for a future purchase. The patient did not respond to attempts for add'l event details and no further info was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1313525-2014-00001 |
| MDR Report Key | 3678929 |
| Report Source | 04 |
| Date Received | 2014-02-21 |
| Date of Report | 2014-01-24 |
| Date Mfgr Received | 2014-01-24 |
| Date Added to Maude | 2014-03-18 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 1400 NORTH GOODMAN ST. |
| Manufacturer City | ROCHESTER NY 146093547 |
| Manufacturer Country | US |
| Manufacturer Postal | 146093547 |
| Manufacturer Phone | 5853388549 |
| Manufacturer G1 | BAUSCH & LOMB, INC. |
| Manufacturer Street | 1400 NORTH GOODMAN ST. |
| Manufacturer City | ROCHESTER NY 14609354 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14609 3547 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOSTON ADVANCE CONDITIONING SOLUTION |
| Generic Name | SOFT CONTACT LENS CARE PRODUCT |
| Product Code | LYL |
| Date Received | 2014-02-21 |
| 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, INC. |
| Manufacturer Address | 1400 NORTH GOODMAN ST. ROCHESTER NY 14609354 US 14609 3547 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-02-21 |