MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-07-20 for BOSTON ADVANCE CONDITIONING SOLUTION manufactured by Bausch & Lomb.
[2841101]
Optometrist in (b)(6) reported a orthokeratology patient diagnosed with acanthamoeba keratitis. Patient was initially seen by optometrist and referred to ophthalmologist due to suspected acanthamoeba keratitis. Patient was admitted to hospital on (b)(6) 2012. Anterior stromal calcification was present, a corneal scraping was performed and acanthamoeba cysts were confirmed. Aggressive therapy was administered, but the patient slowly responded to treatment. Penetrating keratoplasty will be performed once the patient's corneal tissue is substantial enough to accept the transplanted corneal tissue. Doctor feels the solution is not likely the cause of the event and relates condition to the tap water rinsing of the contact lens and the topping of the storage solution.
Patient Sequence No: 1, Text Type: D, B5
[10054130]
The product was not returned for evaluation. The lot number is unknown. Doctor feels the solution is not likely the cause of the event and relates condition to the tap water rinsing of the contact lens and the topping of the storage solution. Based on all information, no causal factors can be determined and no conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1313525-2012-00020 |
| MDR Report Key | 2670560 |
| Report Source | 01,05 |
| Date Received | 2012-07-20 |
| Date of Report | 2012-06-26 |
| Date of Event | 2012-03-07 |
| Date Mfgr Received | 2012-06-26 |
| Date Added to Maude | 2012-07-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| 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 | 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 | BOSTON ADVANCE CONDITIONING SOLUTION |
| Product Code | LYL |
| Date Received | 2012-07-20 |
| 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 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-07-20 |