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 2010-06-22 for BOSTON ORTHO-K (OPRIFOCON A) SHAPING LENS manufactured by Bausch + Lomb.
[17060508]
Patient presented to a local clinic with symptoms of ocular pain, light sensitivity, and decreased vision in both eyes, after wearing orthokeratology contact lenses over night for five days. The patient was diagnosed as having bilateral infectious corneal ulcers, with either viral or fungal keratitis. The patient was treated with antiviral and antifungal medications. Approximately one month later, the patient presented to a hospital doctor, as symptoms continued after one month of treatment. The patient was diagnosed as having (b)(6) infection, with a secondary bacterial infections. The patient was treated with antiprotozoal, antibiotic, and anti-inflammatory therapy. After one month of treatment, the corneal ulcer had healed, and the patient's best corrected visual acuity was 20/100 od and 20/25 os.
Patient Sequence No: 1, Text Type: D, B5
[17285376]
The device was not returned to the manufacturer and no lot number information was provided. However, the doctor stated that irregular cleaning and disinfecting of lenses, along with the use of tap water during lens cleaning by the patient, seemed to have caused the event. 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 | 1313525-2010-00009 |
| MDR Report Key | 1738433 |
| Report Source | 01,03,05 |
| Date Received | 2010-06-22 |
| Date of Report | 2010-06-04 |
| Date Mfgr Received | 2010-06-04 |
| Date Added to Maude | 2010-07-16 |
| 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 | TES PROUD |
| Manufacturer Street | 1400 NORTH GOODMAN STREET |
| Manufacturer City | ROCHESTER NY 14609 |
| Manufacturer Country | US |
| Manufacturer Postal | 14609 |
| Manufacturer Phone | 5853388549 |
| Manufacturer G1 | BAUSCH & LOMB WILMINGTON |
| Manufacturer Street | 100 RESEARCH DRIVE |
| Manufacturer City | WILMINGTON MA 01887440 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01887 4406 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOSTON ORTHO-K (OPRIFOCON A) SHAPING LENS |
| Product Code | MUW |
| Date Received | 2010-06-22 |
| 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. Required No Informationntervention | 2010-06-22 |