MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,03,05 report with the FDA on 2012-01-11 for BOSTON ADVANCE CONDITIONING SOLUTION manufactured by Bausch + Lomb.
[2429072]
Article stated a (b)(6) female pt presented with ocular pain, blurred vision, eyelid swelling, and foreign body sensation in the right eye. Pt was initially mis-diagnosed and treated for possible viral keratitis due to (b)(6). Pt did not respond to treatment and six weeks later, corneal scrapings were positive for (b)(6). Pt was treated with chlorhexidine, propamidine, and cycloplegic eye drops which resulted in significant improvement. Pt followed treatment for three months and possibly to continue for a year. Upon questioning, the pt stated used tap water to "wash" the lenses and her own saliva to moisten them. The lenses and lens case were approx 10 yrs old.
Patient Sequence No: 1, Text Type: D, B5
[9581335]
The product was not returned for eval. The lot number is unk. The article noted that the pt did not fully comply with proper lens care maintenance. Based on all info, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1313525-2012-00002 |
| MDR Report Key | 2421261 |
| Report Source | 01,03,05 |
| Date Received | 2012-01-11 |
| Date of Report | 2011-09-27 |
| Date Mfgr Received | 2011-09-27 |
| Date Added to Maude | 2012-01-19 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARLENE MARTRANO |
| Manufacturer Street | 1400 NORTH GOODMAN ST. |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 5853388995 |
| Manufacturer G1 | BAUSCH + LOMB |
| Manufacturer Street | VIA PASUBIO 34 |
| Manufacturer City | MACHERIO, MILAN 20050 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 20050 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOSTON ADVANCE CONDITIONING SOLUTION |
| Product Code | LYL |
| Date Received | 2012-01-11 |
| 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 |
| Manufacturer Address | ROCHESTER NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2012-01-11 |